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Trial record 53 of 720 for:    Botulinum Toxins, Type A

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Upper Limb Spasticity

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: NCT01153815
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : May 17, 2012
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cerebrovascular Accident
Interventions Drug: GSK1358820(Botulinum toxin type A)
Drug: placebo
Enrollment 170
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo BTX 200 U
Hide Arm/Group Description Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Period Title: Overall Study
Started 83 87
Completed 74 82
Not Completed 9 5
Reason Not Completed
Adverse Event             3             1
Withdrawal by Subject             6             4
Arm/Group Title Placebo BTX 200 U Total
Hide Arm/Group Description Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). Total of all reporting groups
Overall Number of Baseline Participants 83 87 170
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 87 participants 170 participants
56.3  (12.23) 55.4  (10.69) 55.8  (11.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 87 participants 170 participants
Female
18
  21.7%
23
  26.4%
41
  24.1%
Male
65
  78.3%
64
  73.6%
129
  75.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Chinese Number Analyzed 83 participants 87 participants 170 participants
83 87 170
1.Primary Outcome
Title Change From Baseline at Week 6 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)
Hide Description The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 was calculated as the value at Week 6 minus the value at Baseline.
Time Frame Baseline (Day 0) and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) Population: all randomized and treated participants. The missing data imputation method was used for analysis. For each participant, missing data points were replaced by the mean of the non-missing scores from both treatment groups for that variable at the specific visit.
Arm/Group Title Placebo BTX 200 U
Hide Arm/Group Description:
Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Overall Number of Participants Analyzed 83 87
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.56  (0.735) -1.21  (0.936)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BTX 200 U
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Exact Smirnov test
Comments [Not Specified]
2.Secondary Outcome
Title Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score
Hide Description The MAS wrist score was assessed by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Mean change from Baseline for the MAS wrist score was calculated as the value at Week 6 and Week 12 minus the value at Baseline. In a graph plotting time points on the horizontal axis (HA) and changes from Baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the HA was calculated and used as a summary index (AUC) for assessment of the MAS wrist score.
Time Frame Baseline (Day 0), Week 6, and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. The missing data imputation method was used for analysis.
Arm/Group Title Placebo BTX 200 U
Hide Arm/Group Description:
Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Overall Number of Participants Analyzed 83 87
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 6 -2.341  (2.8894) -5.672  (4.3340)
Week 12 -5.618  (6.5412) -12.712  (9.0510)
3.Secondary Outcome
Title Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS
Hide Description The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.
Time Frame Baseline (Day 0) and Weeks 1, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. The missing data imputation method was used for analysis.
Arm/Group Title Placebo BTX 200 U
Hide Arm/Group Description:
Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Overall Number of Participants Analyzed 83 87
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 -0.31  (0.504) -0.80  (0.752)
Week 4 -0.46  (0.581) -1.14  (0.843)
Week 8 -0.59  (0.757) -1.27  (0.926)
Week 12 -0.48  (0.640) -1.01  (0.822)
4.Secondary Outcome
Title Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits
Hide Description Wrist treatment responders were defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension).
Time Frame Weeks 1, 4, 6, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. The missing data imputation method was used for analysis.
Arm/Group Title Placebo BTX 200 U
Hide Arm/Group Description:
Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Overall Number of Participants Analyzed 83 87
Measure Type: Number
Unit of Measure: participants
Week 1 24 51
Week 4 33 63
Week 6 36 62
Week 8 36 64
Week 12 23 54
5.Secondary Outcome
Title Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS
Hide Description The investigator, physiotherapist, or occupational therapist extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.
Time Frame Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. The missing data imputation method was used for analysis.
Arm/Group Title Placebo BTX 200 U
Hide Arm/Group Description:
Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Overall Number of Participants Analyzed 83 87
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 -0.30  (0.552) -0.67  (0.769)
Week 4 -0.37  (0.654) -0.98  (0.848)
Week 6 -0.42  (0.718) -1.05  (0.879)
Week 8 -0.45  (0.683) -1.04  (0.834)
Week 12 -0.28  (0.639) -0.73  (0.773)
6.Secondary Outcome
Title Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS
Hide Description The investigator, physotherapist, or occupational therapist extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.
Time Frame Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. Only participants with thumb spasticity who received injection in the thumb muscles were evaluated. The missing data imputation method was used for analysis.
Arm/Group Title Placebo BTX 200 U
Hide Arm/Group Description:
Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Overall Number of Participants Analyzed 66 57
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 -0.33  (0.546) -0.85  (0.841)
Week 4 -0.44  (0.655) -1.02  (0.820)
Week 6 -0.53  (0.758) -1.06  (0.844)
Week 8 -0.51  (0.804) -1.06  (0.861)
Week 12 -0.43  (0.759) -0.80  (0.797)
7.Secondary Outcome
Title Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS)
Hide Description The investigator assessed 4 areas of disability, hygiene, pain, dressing, and limb posture, using the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the first dose, the investigator, in consultation with the participant, selected 1functional disability item (which had to have a score of 2 or greater as measured on the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at the indicated time points was calculated as the value at Weeks 1, 4, 6, 8, and 12 minus the value at Baseline.
Time Frame Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. The missing data imputation method was used for analysis.
Arm/Group Title Placebo BTX 200 U
Hide Arm/Group Description:
Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Overall Number of Participants Analyzed 83 87
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 -0.13  (0.406) -0.32  (0.560)
Week 4 -0.18  (0.446) -0.49  (0.663)
Week 6 -0.28  (0.548) -0.54  (0.696)
Week 8 -0.29  (0.594) -0.59  (0.708)
Week 12 -0.29  (0.571) -0.53  (0.676)
8.Secondary Outcome
Title Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points
Hide Description The physician used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsenig, -0=unchanged, +4=very marked improvement) at the indicated time points.
Time Frame Weeks 1, 4, 6, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. The missing data imputation method was used for analysis.
Arm/Group Title Placebo BTX 200 U
Hide Arm/Group Description:
Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Overall Number of Participants Analyzed 83 87
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 0.5  (0.80) 1.2  (1.01)
Week 4 0.7  (0.94) 1.5  (1.08)
Week 6 0.7  (1.04) 1.5  (1.12)
Week 8 0.7  (0.98) 1.4  (1.08)
Week 12 0.6  (0.86) 1.2  (1.06)
9.Secondary Outcome
Title GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points
Hide Description The care giver or participants used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, -0=unchanged, +4=very marked improvement) at the indicated time point.
Time Frame Weeks 1, 4, 6, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. The missing data imputation method was used for analysis.
Arm/Group Title Placebo BTX 200 U
Hide Arm/Group Description:
Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Overall Number of Participants Analyzed 83 87
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 0.6  (0.81) 1.1  (1.05)
Week 4 0.7  (0.93) 1.4  (1.14)
Week 6 0.7  (1.06) 1.5  (1.13)
Week 8 0.7  (0.99) 1.5  (1.08)
Week 12 0.5  (0.85) 1.2  (1.02)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo BTX 200 U
Hide Arm/Group Description Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
All-Cause Mortality
Placebo BTX 200 U
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo BTX 200 U
Affected / at Risk (%) Affected / at Risk (%)
Total   1/83 (1.20%)   2/87 (2.30%) 
Injury, poisoning and procedural complications     
Wound  1  1/83 (1.20%)  0/87 (0.00%) 
Nervous system disorders     
Cerebral infarction  1  0/83 (0.00%)  1/87 (1.15%) 
Convulsion  1  0/83 (0.00%)  1/87 (1.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo BTX 200 U
Affected / at Risk (%) Affected / at Risk (%)
Total   21/83 (25.30%)   16/87 (18.39%) 
Blood and lymphatic system disorders     
Thrombocytopenia  1  1/83 (1.20%)  0/87 (0.00%) 
Cardiac disorders     
Angina pectoris  1  1/83 (1.20%)  0/87 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/83 (1.20%)  0/87 (0.00%) 
Gastrointestinal disorders     
Diarrhea  1  1/83 (1.20%)  1/87 (1.15%) 
Nausea  1  1/83 (1.20%)  0/87 (0.00%) 
Vomiting  1  1/83 (1.20%)  0/87 (0.00%) 
General disorders     
Pyrexia  1  2/83 (2.41%)  0/87 (0.00%) 
Immune system disorders     
Hypersensitivity  1  1/83 (1.20%)  0/87 (0.00%) 
Infections and infestations     
Upper respiratory tract infection  1  1/83 (1.20%)  1/87 (1.15%) 
Varicella  1  0/83 (0.00%)  1/87 (1.15%) 
Erysipelas  1  1/83 (1.20%)  0/87 (0.00%) 
Nasopharyngitis  1  1/83 (1.20%)  0/87 (0.00%) 
Pneumonia  1  1/83 (1.20%)  0/87 (0.00%) 
Urinary tract infection  1  1/83 (1.20%)  0/87 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  0/83 (0.00%)  1/87 (1.15%) 
Head injury  1  1/83 (1.20%)  0/87 (0.00%) 
Investigations     
Blood bilirubin increased  1  0/83 (0.00%)  1/87 (1.15%) 
Blood urea increased  1  0/83 (0.00%)  1/87 (1.15%) 
Gamma-glutamyltransferase increased  1  1/83 (1.20%)  1/87 (1.15%) 
Lipids abnormal  1  0/83 (0.00%)  1/87 (1.15%) 
Platelet count decreased  1  0/83 (0.00%)  1/87 (1.15%) 
Alanine aminotransferase increased  1  1/83 (1.20%)  0/87 (0.00%) 
Blood cholesterol increased  1  1/83 (1.20%)  0/87 (0.00%) 
Blood glucose increased  1  2/83 (2.41%)  0/87 (0.00%) 
Blood potassium increased  1  1/83 (1.20%)  0/87 (0.00%) 
Blood triglycerides increased  1  1/83 (1.20%)  0/87 (0.00%) 
Liver function test abnormal  1  2/83 (2.41%)  0/87 (0.00%) 
Platelet count abnormal  1  1/83 (1.20%)  0/87 (0.00%) 
Urine analysis abnormal  1  1/83 (1.20%)  0/87 (0.00%) 
Metabolism and nutrition disorders     
Hyperlipidemia  1  1/83 (1.20%)  2/87 (2.30%) 
Electrolyte imbalance  1  0/83 (0.00%)  1/87 (1.15%) 
Hypokalemia  1  1/83 (1.20%)  1/87 (1.15%) 
Hyperglycemia  1  1/83 (1.20%)  0/87 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  0/83 (0.00%)  1/87 (1.15%) 
Pain in extremity  1  0/83 (0.00%)  1/87 (1.15%) 
Nervous system disorders     
Epilepsy  1  2/83 (2.41%)  1/87 (1.15%) 
Psychiatric disorders     
Bruxism  1  0/83 (0.00%)  1/87 (1.15%) 
Renal and urinary disorders     
Renal failure  1  1/83 (1.20%)  0/87 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  2/83 (2.41%)  1/87 (1.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01153815     History of Changes
Other Study ID Numbers: 112958
First Submitted: June 17, 2010
First Posted: June 30, 2010
Results First Submitted: April 19, 2012
Results First Posted: May 17, 2012
Last Update Posted: June 28, 2017