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Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00666263
Recruitment Status : Completed
First Posted : April 24, 2008
Results First Posted : March 13, 2013
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multifocal Motor Neuropathy
Interventions Biological: Immune Globulin Intravenous (human), 10%
Biological: 0.25% human albumin solution (Placebo)
Enrollment 50
Recruitment Details Recruitment was conducted in the U.S., Canada, and Europe at 17 study sites. The first participant was enrolled in August 2008.
Pre-assignment Details Fifty unique potential participants were enrolled at clinical study sites in North America and Europe. Six were screen failures. Therefore, 44 participants were randomized.
Arm/Group Title IGIV, 10% Then Placebo (During Cross-Over Periods) Placebo Then IGIV, 10% (During Cross-Over Periods)
Hide Arm/Group Description Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3) Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)
Period Title: Study Part 1 (Stabilization Phase 1)
Started 22 22
Completed 22 21
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Period Title: Study Part 2 (Cross-over Period 1)
Started 22 21
Completed 22 21
Not Completed 0 0
Period Title: Study Part 3 (Stabilization Phase 2)
Started 22 21
Completed 22 21
Not Completed 0 0
Period Title: Study Part 4 (Cross-over Period 2)
Started 22 21
Completed 21 21
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Study Part 5 (Stabilization Phase 3)
Started 21 21
Completed 21 20
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: End of Study Visit
Started 22 [1] 22 [1]
Completed 22 22
Not Completed 0 0
[1]
End of Study Visit done on all 22 randomized regardless of participation in Study Parts
Arm/Group Title All Study Participants
Hide Arm/Group Description Each participant was to complete 5 study parts (3 stabilization phases of open label treatment with IGIV, 10%, and 1 cross-over period each of double-blind treatment with IGIV, 10% and placebo according to a randomized sequence). Each study part lasted 12 weeks and comprised 3, 4 or 6 infusion cycles depending on treatment interval. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) for all participants Study Part 2: Participants were randomized to 1 of 2 sequences of double-blind treatment (either: IGIV, 10% or placebo) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Participants were crossed-over to second sequence of double-blind treatment (IGIV, 10% or placebo) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
51.64  (10.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
12
  27.3%
Male
32
  72.7%
1.Primary Outcome
Title Grip Strength in the More Affected Hand
Hide Description The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand.
Time Frame Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Before Stabilization 1 End of Stabilization 1 End of Cross-Over 1 End of Stabilization 2 End of Cross-Over 2 End of Stabilization 3 End of the Study
Hide Arm/Group Description:
Baseline Measurements
IGIV, 10% (IGIV)
Either IGIV, 10% or Placebo
IGIV, 10%
Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
IGIV, 10%
Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
Overall Number of Participants Analyzed 44 44 42 43 43 36 43
Median (Inter-Quartile Range)
Unit of Measure: kilograms
IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
18.14
(9.30 to 30.43)
21.68
(14.05 to 30.83)
19.54
(10.15 to 29.15)
19.39
(12.75 to 33.25)
11.28
(5.50 to 25.92)
17.77
(9.23 to 27.07)
17.37
(10.80 to 29.03)
Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
13.17
(5.30 to 20.08)
14.17
(8.08 to 27.47)
8.38
(4.86 to 17.03)
14.18
(7.60 to 27.35)
15.98
(10.73 to 29.65)
14.28
(9.47 to 28.25)
14.00
(7.48 to 24.82)
2.Primary Outcome
Title Mean Relative Change in Grip Strength in the More Affected Hand
Hide Description Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.
Time Frame Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- Crossover Period 1 Arm 1: IGIV, 10% Then Placebo- Crossover Period 2 Arm 2: Placebo Then IGIV, 10% - Crossover Period 1 Arm 2: Placebo Then IGIV, 10% - Crossover Period 2
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 20 21
Mean (95% Confidence Interval)
Unit of Measure: Percent change in grip strength
-16.36
(-30.92 to -1.80)
-30.52
(-43.68 to -17.36)
-30.11
(-48.41 to -11.81)
23.86
(-23.11 to 70.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: IGIV, 10% Then Placebo- Crossover Period 1, Arm 1: IGIV, 10% Then Placebo- Crossover Period 2, Arm 2: Placebo Then IGIV, 10% - Crossover Period 1, Arm 2: Placebo Then IGIV, 10% - Crossover Period 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANOVA
Comments Fixed effects ANOVA with factors for sequence (1 or 2), nested within sequence, period (Cross-Over Period 1 or 2), & treatment (IGIV, 10% or placebo)
Method of Estimation Estimation Parameter Difference in least squared means
Estimated Value 35.13
Confidence Interval (2-Sided) 95%
8.81 to 61.46
Estimation Comments [Not Specified]
3.Primary Outcome
Title Co-Primary Endpoint: Guy's Neurologic Disability Scale (GNDS) for Upper Limbs
Hide Description GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.
Time Frame Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Before Stabilization 1 End of Stabilization 1 End of Cross-Over 1 End of Stabilization 2 End of Cross-Over 2 End of Stabilization 3 End of the Study
Hide Arm/Group Description:
Baseline Measurements
IGIV, 10% (IGIV)
Either IGIV, 10% or Placebo
IGIV, 10%
Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
IGIV, 10%
Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
Overall Number of Participants Analyzed 44 44 42 43 43 36 43
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale
IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
2.0
(2.0 to 3.0)
2.0
(2.0 to 2.0)
2.0
(2.0 to 2.0)
2.0
(2.0 to 3.0)
2.5
(2.0 to 3.0)
2.0
(2.0 to 2.0)
2.0
(2.0 to 2.0)
Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
2.0
(2.0 to 3.0)
2.0
(2.0 to 3.0)
2.0
(2.0 to 3.0)
2.0
(1.0 to 3.0)
2.0
(2.0 to 3.0)
2.0
(2.0 to 3.0)
2.0
(2.0 to 3.0)
4.Primary Outcome
Title Co-Primary Endpoint: Proportion of Participants With Deterioration in Guy's Neurological Disability Score (GNDS)
Hide Description GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.
Time Frame Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Deterioration After IGIV, 10% and Placebo Deterioration After Placebo, But Not IGIV, 10% Deterioration After IGIV, 10%, But Not Placebo No Deterioration After IGIV, 10% or Placebo
Hide Arm/Group Description:
Participants with deterioration in GNDS scores after IGIV, 10% and placebo
Participants with deterioration in GNDS scores after Placebo, but not IGIV, 10%
Participants with deterioration in GNDS scores after IGIV, 10%, but not Placebo
Participants with no deterioration in GNDS scores after IGIV, 10% or Placebo
Overall Number of Participants Analyzed 42 42 42 42
Measure Type: Number
Unit of Measure: Proportion of participants
4.8 35.7 11.9 47.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deterioration After IGIV, 10% and Placebo, Deterioration After Placebo, But Not IGIV, 10%, Deterioration After IGIV, 10%, But Not Placebo, No Deterioration After IGIV, 10% or Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
5.Primary Outcome
Title Rate of Temporally Associated Adverse Events (AEs) Per Infusion
Hide Description The total number of all AEs which begin during or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product (IGIV, 10% or Placebo), divided by the total number of infusions, and multiplied by 100.
Time Frame Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Dataset
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
 104 68 61 138
Measure Type: Number
Unit of Measure: Percentage of AEs per infusion
11.5 13.2 24.6 11.6
6.Primary Outcome
Title The Percentage of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason
Hide Description [Not Specified]
Time Frame Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Dataset
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 21 21
Measure Type: Number
Unit of Measure: percentage of participants
9.1 0.0 4.8 4.8
7.Primary Outcome
Title The Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason
Hide Description [Not Specified]
Time Frame Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Dataset
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
 104 68 61 138
Measure Type: Number
Unit of Measure: percentage of infusions
2.9 0.0 1.6 0.7
8.Primary Outcome
Title The Percentage of Participants Reporting One or More Moderate or Severe AEs That Began During Infusion or Within 72 Hours of Completion of an Infusion
Hide Description [Not Specified]
Time Frame Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Dataset
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 21 21
Measure Type: Number
Unit of Measure: percentage of participants
4.5 27.3 19.0 4.8
9.Secondary Outcome
Title Percentage of Participants With at Least a 30% Decline in Relative Grip Strength in the More Affected Hand (Measured Using a DynEx Digital Dynamometer)
Hide Description Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.
Time Frame Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
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Hide Analysis Population Description
Intent to treat
Arm/Group Title Decline Only During IGIV, 10% Decline Only During Placebo Decline During Both Placebo and IGIV, 10% No Decline During Placebo or IGIV, 10%
Hide Arm/Group Description:
Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, but not after the placebo
Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following the placebo, but not after IGIV, 10%
Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
Participants who did not experience a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
Overall Number of Participants Analyzed 42 42 42 42
Measure Type: Number
Unit of Measure: Percentage of participants
4.8 42.9 4.8 47.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Decline Only During IGIV, 10%, Decline Only During Placebo, Decline During Both Placebo and IGIV, 10%, No Decline During Placebo or IGIV, 10%
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
10.Secondary Outcome
Title Grip Strength in the Less Affected Hand
Hide Description The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand.
Time Frame Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Before Stabilization 1 End of Stabilization 1 End of Cross-Over 1 End of Stabilization 2 End of Cross-Over 2 End of Stabilization 3 End of the Study
Hide Arm/Group Description:
Baseline Measurements
IGIV, 10% (IGIV)
Either IGIV, 10% or Placebo
IGIV, 10%
Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
IGIV, 10%
Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
Overall Number of Participants Analyzed 44 44 42 43 43 36 43
Median (Inter-Quartile Range)
Unit of Measure: kilograms
IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
27.98
(22.35 to 36.35)
29.52
(23.28 to 36.98)
29.79
(20.48 to 37.88)
29.17
(21.68 to 37.70)
26.58
(13.67 to 32.83)
28.97
(15.95 to 34.38)
29.68
(14.72 to 34.35)
Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
27.23
(18.73 to 34.45)
28.23
(19.72 to 36.80)
20.28
(9.61 to 33.44)
26.92
(17.52 to 37.72)
27.35
(21.58 to 37.12)
25.72
(20.18 to 36.55)
24.98
(16.02 to 35.85)
11.Secondary Outcome
Title Mean Relative Change in Grip Strength in the Less Affected Hand
Hide Description Relative Change is defined as 100 * (End of the Cross-Over Period - Baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.
Time Frame Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
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Hide Analysis Population Description
Intent to treat
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1 Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2 Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1 Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 20 21
Mean (95% Confidence Interval)
Unit of Measure: Percent change in grip strength
-2.52
(-7.90 to 2.85)
-17.96
(-29.81 to -6.10)
-29.22
(-40.62 to -17.83)
19.67
(-10.84 to 50.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1, Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2, Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1, Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squared means
Estimated Value 32.54
Confidence Interval (2-Sided) 95%
14.01 to 51.06
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Proportion of Participants That Were Accelerated Forward Into the Next Stabilization Phase (ie Switched to Open-Label IGIV, 10%)
Hide Description Participants were permitted to switch from blinded treatment with placebo or IGIV, 10% to open label IGIV, 10% if they and investigator agreed that deterioration had occurred to the extent that the participant had unacceptable difficulty carrying out daily activities involving the affected muscles, or decline in grip strength of ≥50% in the more affected hand had occurred.
Time Frame During the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
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Intent to treat
Arm/Group Title Accelerated Switch During IGIV, 10% and Placebo Accelerated Switch During Placebo, But Not IGIV, 10% Accelerated Switch During IGIV, 10%, But Not Placebo No Accelerated Switch During IGIV, 10% or Placebo
Hide Arm/Group Description:
Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, and placebo
Participants who required a switch to open label IGIV, 10% when receiving the placebo, but not during IGIV, 10%
Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, but not during placebo
Participants who did not require a switch to open label IGIV, 10% when receiving IGIV, 10%, or placebo
Overall Number of Participants Analyzed 42 42 42 42
Measure Type: Number
Unit of Measure: Proportion of participants
0.0 69.0 2.4 28.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Accelerated Switch During IGIV, 10% and Placebo, Accelerated Switch During Placebo, But Not IGIV, 10%, Accelerated Switch During IGIV, 10%, But Not Placebo, No Accelerated Switch During IGIV, 10% or Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
13.Secondary Outcome
Title Patient Global Impression of Change
Hide Description Patient Global Impression of Change was measured on an ordinal scale of 1-7, higher scores representing greater perceived deterioration since the previous efficacy assessment (ranging from (1) very much improved to very much worse (7)). 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse
Time Frame Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
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Intent to treat
Arm/Group Title End of Stabilization 1 End of Cross-Over 1 End of Stabilization 2 End of Cross-Over 2 End of Stabilization 3 End of the Study
Hide Arm/Group Description:
(IGIV, 10%)
Either IGIV, 10% or Placebo
(IGIV, 10%)
Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
(IGIV, 10%)
Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
Overall Number of Participants Analyzed 44 42 43 43 36 43
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale
IGIV, 10% then Placebo (N= 22, 22, 22, 21, 17, 21)
4.0
(3.0 to 4.0)
4.0
(4.0 to 4.0)
4.0
(4.0 to 4.0)
5.0
(5.0 to 6.0)
2.0
(2.0 to 4.0)
4.0
(3.0 to 4.0)
Placebo then IGIV, 10% (N= 22, 20, 21, 21, 19, 22)
4.0
(3.0 to 4.0)
6.0
(5.0 to 6.0)
3.0
(2.0 to 3.0)
4.0
(3.0 to 4.0)
4.0
(4.0 to 4.0)
4.0
(4.0 to 4.0)
14.Secondary Outcome
Title Overall Disability Sum Score
Hide Description The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability. Overall disability sum score = arm disability scale (range 0-5) + leg disability scale (range 0-7); Overall Range: 0 (no signs of disability) to 12 (maximum disability).
Time Frame Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Before Stabilization 1 End of Stabilization 1 End of Cross-Over 1 End of Stabilization 2 End of Cross-Over 2 End of Stabilization 3 End of the Study
Hide Arm/Group Description:
Baseline Measurements
IGIV, 10% (IGIV)
Either IGIV, 10% or Placebo
IGIV, 10%
Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
IGIV, 10%
Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
Overall Number of Participants Analyzed 44 44 42 43 43 36 43
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale
IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
3
(2 to 4)
2
(2 to 4)
3
(2 to 4)
2
(2 to 4)
3
(2 to 4)
2
(2 to 4)
2
(2 to 4)
Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
3
(2 to 4)
3
(2 to 4)
4
(3 to 5)
3
(2 to 4)
3
(2 to 4)
4
(2 to 4)
3
(2 to 4)
15.Secondary Outcome
Title Overall Disability Sum Score - Standardized
Hide Description The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability. Overall disability sum score = arm disability scale (range 0-5) + leg disability scale (range 0-7); Overall Range: 0 (no signs of disability) to 12 (maximum disability). This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes.
Time Frame Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Before Stabilization 1 End of Stabilization 1 End of Cross-Over 1 End of Stabilization 2 End of Cross-Over 2 End of Stabilization 3 End of the Study
Hide Arm/Group Description:
Baseline Measurements
IGIV, 10% (IGIV)
Either IGIV, 10% or Placebo
IGIV, 10%
Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
IGIV, 10%
Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
Overall Number of Participants Analyzed 44 44 42 43 43 36 43
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale
IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
75.0
(66.7 to 83.3)
83.3
(66.7 to 83.3)
79.2
(66.7 to 83.3)
83.3
(66.7 to 83.3)
75.0
(66.7 to 83.3)
83.3
(66.7 to 83.3)
83.3
(66.7 to 83.3)
Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
75.0
(66.7 to 83.3)
75.0
(66.7 to 83.3)
66.7
(58.3 to 75.0)
75.0
(66.7 to 83.3)
75.0
(66.7 to 83.3)
66.7
(66.7 to 83.3)
75.0
(66.7 to 83.3)
16.Secondary Outcome
Title Mean Relative Change in Overall Disability Sum Score
Hide Description Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability (from 0, "no signs of disability" to 12, "most severe disability"). This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes.
Time Frame Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1 Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2 Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1 Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 20 21
Mean (95% Confidence Interval)
Unit of Measure: percent change in score
-3.14
(-6.55 to 0.27)
-5.77
(-10.33 to -1.20)
-8.46
(-12.81 to -4.11)
0.92
(-2.88 to 4.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1, Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2, Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1, Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squared Means
Estimated Value 6.03
Confidence Interval (2-Sided) 95%
2.14 to 9.92
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand
Hide Description The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.
Time Frame Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Before Stabilization 1 End of Stabilization 1 End of Cross-Over 1 End of Stabilization 2 End of Cross-Over 2 End of Stabilization 3 End of the Study
Hide Arm/Group Description:
Baseline Measurements
IGIV, 10% (IGIV)
Either IGIV, 10% or Placebo
IGIV, 10%
Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
IGIV, 10%
Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
Overall Number of Participants Analyzed 44 44 42 43 43 36 43
Median (Inter-Quartile Range)
Unit of Measure: Seconds
IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
20.75
(19.50 to 27.50)
22.00
(19.50 to 29.00)
20.25
(18.00 to 29.00)
21.00
(18.00 to 24.50)
20.50
(18.50 to 27.50)
20.50
(19.00 to 24.50)
20.00
(19.00 to 25.50)
Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
26.75
(20.50 to 39.00)
25.25
(19.00 to 33.50)
27.75
(23.00 to 43.50)
24.50
(19.00 to 34.50)
25.00
(20.00 to 30.50)
27.50
(20.50 to 35.50)
26.25
(19.50 to 33.00)
18.Secondary Outcome
Title Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand
Hide Description Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.
Time Frame Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
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Intent to treat
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1 Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2 Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1 Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 20 21
Mean (95% Confidence Interval)
Unit of Measure: Percent change in time
-2.57
(-9.99 to 4.86)
3.90
(-4.59 to 12.39)
29.89
(12.46 to 47.31)
4.89
(-9.45 to 19.23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1, Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2, Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1, Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squared Means
Estimated Value -15.57
Confidence Interval (2-Sided) 95%
-24.37 to -6.77
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand
Hide Description The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.
Time Frame Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
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Intent to treat
Arm/Group Title Before Stabilization 1 End of Stabilization 1 End of Cross-Over 1 End of Stabilization 2 End of Cross-Over 2 End of Stabilization 3 End of the Study
Hide Arm/Group Description:
Baseline Measurements
IGIV, 10% (IGIV)
Either IGIV, 10% or Placebo
IGIV, 10%
Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
IGIV, 10%
Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
Overall Number of Participants Analyzed 44 44 42 43 43 36 43
Median (Inter-Quartile Range)
Unit of Measure: Seconds
IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
25.75
(20.00 to 29.50)
22.50
(19.50 to 27.00)
24.00
(19.50 to 28.50)
23.50
(19.50 to 27.00)
25.25
(22.50 to 29.50)
21.00
(19.50 to 24.50)
23.00
(20.50 to 26.50)
Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
31.25
(22.50 to 51.00)
28.00
(22.50 to 40.00)
37.25
(26.25 to 82.75)
31.50
(24.00 to 38.50)
32.50
(22.00 to 41.00)
30.00
(22.50 to 39.50)
30.00
(21.00 to 38.50)
20.Secondary Outcome
Title Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand
Hide Description Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.
Time Frame Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
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Hide Analysis Population Description
Intent to treat
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1 Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2 Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1 Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 20 21
Mean (95% Confidence Interval)
Unit of Measure: Percent change in time
4.78
(-1.65 to 11.21)
13.06
(4.46 to 21.65)
52.93
(26.82 to 79.05)
8.56
(-4.88 to 22.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1, Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2, Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1, Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squared Means
Estimated Value -26.11
Confidence Interval (2-Sided) 95%
-38.96 to -13.26
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)
Hide Description The VAS measured patients' assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents "no symptoms" and 10 "disabled, unable to use affected limbs".
Time Frame Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Before Stabilization 1 End of Stabilization 1 End of Cross-Over 1 End of Stabilization 2 End of Cross-Over 2 End of Stabilization 3 End of the Study
Hide Arm/Group Description:
Baseline Measurements
IGIV, 10% (IGIV)
Either IGIV, 10% or Placebo
IGIV, 10%
Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
IGIV, 10%
Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
Overall Number of Participants Analyzed 44 44 42 43 43 36 43
Median (Inter-Quartile Range)
Unit of Measure: Scores on a scale
IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
4.80
(2.90 to 6.30)
2.95
(1.60 to 5.10)
4.10
(2.00 to 5.60)
3.50
(1.70 to 5.10)
6.85
(5.90 to 8.10)
4.50
(2.60 to 5.10)
3.70
(1.90 to 5.40)
Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
4.95
(2.30 to 7.60)
3.15
(2.70 to 5.50)
7.15
(6.75 to 7.60)
5.10
(2.30 to 6.10)
4.60
(2.40 to 5.90)
4.50
(2.60 to 6.00)
5.15
(2.80 to 6.30)
22.Secondary Outcome
Title Mean Relative Change in Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)
Hide Description Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The VAS measured patients' assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents "no symptoms" and 10 "disabled, unable to use affected limbs".
Time Frame Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1 Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2 Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1 Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 20 21
Mean (95% Confidence Interval)
Unit of Measure: Percent change in assessment
140.92
(-1.35 to 283.19)
321.75
(-73.45 to 716.95)
258.09
(-100.83 to 617.01)
5.75
(-11.54 to 23.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1, Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2, Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1, Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squared Means
Estimated Value -216.60
Confidence Interval (2-Sided) 95%
-490.41 to 57.22
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Rate of Related AEs Per Infusion
Hide Description The total number of AEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.
Time Frame Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Hide Outcome Measure Data
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Safety Dataset
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
 104 68 61 138
Measure Type: Number
Unit of Measure: AEs per infusion
4.8 20.6 44.3 15.9
24.Secondary Outcome
Title Rate of Related SAEs Per Infusion
Hide Description The total number of SAEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.
Time Frame Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Dataset
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
 104 68 61 138
Measure Type: Number
Unit of Measure: SAEs per infusion
0.0 0.0 0.0 0.7
25.Secondary Outcome
Title The Proportion of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs
Hide Description [Not Specified]
Time Frame Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Dataset
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 21 21
Measure Type: Number
Unit of Measure: proportion of participants
0.0 0.0 0.0 4.8
26.Secondary Outcome
Title The Proportion of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs
Hide Description [Not Specified]
Time Frame Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
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Safety Dataset
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
 104 68 61 138
Measure Type: Number
Unit of Measure: proportion of infusions
0.0 0.0 0.0 0.7
27.Secondary Outcome
Title The Proportion of Infusions Associated With One or More AEs Related to the Study Product
Hide Description [Not Specified]
Time Frame Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Dataset
Arm/Group Title Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
Hide Arm/Group Description:
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
Overall Number of Participants Analyzed 22 22 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
 104 68 61 138
Measure Type: Number
Unit of Measure: proportion of infusions
3.8 19.1 34.4 13.0
28.Post-Hoc Outcome
Title Proportion of Participants With at Least a 30% Decline in Relative Grip Strength in the Less Affected Hand (Measured Using a DynEx Digital Dynamometer)
Hide Description Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.
Time Frame Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
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Intent to treat
Arm/Group Title Decline Only During IGIV, 10% Decline Only During Placebo Decline During Both Placebo and IGIV, 10% No Decline During Placebo and IGIV, 10%
Hide Arm/Group Description:
Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, but not after the placebo
Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following the placebo, but not after IGIV, 10%
Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
Participants who did not experience a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
Overall Number of Participants Analyzed 42 42 42 42
Measure Type: Number
Unit of Measure: Proportion of participants
0.0 31.0 2.4 66.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Decline Only During IGIV, 10%, Decline Only During Placebo, Decline During Both Placebo and IGIV, 10%, No Decline During Placebo and IGIV, 10%
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Time Frame Throughout the study period, approximately three years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IGIV, 10% Placebo
Hide Arm/Group Description Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle) 0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used)
All-Cause Mortality
IGIV, 10% Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
IGIV, 10% Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/44 (4.55%)      0/43 (0.00%)    
Eye disorders     
Vision blurred 1  1/44 (2.27%)  1 0/43 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism 1  1/44 (2.27%)  1 0/43 (0.00%)  0
1
Term from vocabulary, MeDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IGIV, 10% Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/44 (79.55%)      33/43 (76.74%)    
Gastrointestinal disorders     
DIARRHOEA 1  3/44 (6.82%)  3 0/43 (0.00%)  0
NAUSEA 1  3/44 (6.82%)  31 2/43 (4.65%)  3
TOOTHACHE 1  3/44 (6.82%)  3 0/43 (0.00%)  0
General disorders     
INFLUENZA LIKE ILLNESS 1  7/44 (15.91%)  9 1/43 (2.33%)  1
CHEST DISCOMFORT 1  3/44 (6.82%)  3 0/43 (0.00%)  0
FATIGUE 1  3/44 (6.82%)  5 0/43 (0.00%)  0
NASOPHARYNGITIS 1  3/44 (6.82%)  3 2/43 (4.65%)  2
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION 1  9/44 (20.45%)  15 0/43 (0.00%)  0
URINARY TRACT INFECTION 1  3/44 (6.82%)  3 0/43 (0.00%)  0
Injury, poisoning and procedural complications     
CONTUSION 1  5/44 (11.36%)  9 2/43 (4.65%)  2
Musculoskeletal and connective tissue disorders     
MUSCLE SPASMS 1  8/44 (18.18%)  12 2/43 (4.65%)  2
MUSCULAR WEAKNESS 1  6/44 (13.64%)  9 2/43 (4.65%)  3
BACK PAIN 1  5/44 (11.36%)  5 1/43 (2.33%)  2
PAIN IN EXTREMITY 1  4/44 (9.09%)  6 3/43 (6.98%)  3
NECK PAIN 1  3/44 (6.82%)  3 1/43 (2.33%)  1
Nervous system disorders     
HEADACHE 1  16/44 (36.36%)  34 2/43 (4.65%)  3
NEUROLOGICAL DECOMPENSATION 1  10/44 (22.73%)  10 25/43 (58.14%)  25
NEUROLOGICAL SYMPTOM 1  3/44 (6.82%)  3 2/43 (4.65%)  2
PARAESTHESIA 1  3/44 (6.82%)  4 1/43 (2.33%)  1
SINUS HEADACHE 1  3/44 (6.82%)  3 0/43 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
OROPHARYNGEAL PAIN 1  7/44 (15.91%)  8 0/43 (0.00%)  0
SINUS CONGESTION 1  3/44 (6.82%)  3 0/43 (0.00%)  0
1
Term from vocabulary, MeDRA
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Baxter's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 18 months after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥90 days prior to submission or communication. Baxter may request an additional delay of ≤120 days(e.g., for intellectual property protection)
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Shire
Phone: +1 866 842 5335
EMail: ClinicalTransparency@shire.com
Publications of Results:
Koski CL, Schiff RI, Oh M, Lee D. Characteristics of patients with multifocal motor neuropathy enrolled in a randomized controlled trial of intravenous gammaglobulin. Poster. 63rd Annual Meeting of American Academy of Neurology (AAN), April 9-16, 2011, Honolulu, HI, USA.
Other Publications:
Layout table for additonal information
Responsible Party: Takeda ( Baxalta now part of Shire )
ClinicalTrials.gov Identifier: NCT00666263    
Other Study ID Numbers: 160604
2009-013841-27 ( EudraCT Number )
First Submitted: April 23, 2008
First Posted: April 24, 2008
Results First Submitted: October 19, 2012
Results First Posted: March 13, 2013
Last Update Posted: May 19, 2021