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Trial record 43 of 720 for:    Botulinum Toxins, Type A

A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity

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ClinicalTrials.gov Identifier: NCT01205451
Recruitment Status : Completed
First Posted : September 20, 2010
Results First Posted : September 24, 2012
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Spasticity, Post-Stroke
Intervention Drug: Botulinum toxin type A
Enrollment 109
Recruitment Details  
Pre-assignment Details Study LOC114609 (NCT01205451) is the open-label (OL) extension of Study 112958 (a double-blind [DB] study; NCT01153815). Within 3 months of completion of Study 112958, eligible participants were enrolled in Study 114609.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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). Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 53 56
Completed 47 46
Not Completed 6 10
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             5             9
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study Total
Hide Arm/Group Description Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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). Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 53 53 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 53 participants 106 participants
54.4  (10.90) 55.4  (12.53) 54.9  (11.70)
[1]
Measure Description: Baseline characteristics are summarized for members of the Full Analysis Set (FAS), comprised of all enrolled and treated participants with at least one post-treatment modified Ashworth scale (MAS) wrist score. Three participants (all receiving placebo in the original DB study) didn't have any post-treatment MAS wrist score; therefore, the FAS included 106 participants (53 participants in each group).
Gender   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 106 participants
Female
10
  18.9%
10
  18.9%
20
  18.9%
Male
43
  81.1%
43
  81.1%
86
  81.1%
[1]
Measure Description: Baseline characteristics are summarized for members of the Full Analysis Set (FAS), comprised of all enrolled and treated participants with at least one post-treatment MAS wrist score. Three participants (all receiving placebo in the original DB study) didn't have any post-treatment MAS wrist score; therefore, the FAS included 106 participants (53 participants in each group).
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Chinese Number Analyzed 53 participants 53 participants 106 participants
53 53 106
[1]
Measure Description: Baseline characteristics are summarized for members of the Full Analysis Set (FAS), comprised of all enrolled and treated participants with at least one post-treatment MAS wrist score. Three participants (all receiving placebo in the original DB study) didn't have any post-treatment MAS wrist score; therefore, the FAS included 106 participants (53 participants in each group).
Number of participants with the absence or presence of thumb spasticity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 106 participants
Absence 6 6 12
Presence 47 47 94
[1]
Measure Description: Baseline characteristics are summarized for members of the Full Analysis Set (FAS), comprised of all enrolled and treated participants with at least one post-treatment MAS wrist score. Three participants (all receiving placebo in the original DB study) didn't have any post-treatment MAS wrist score; therefore, the FAS included 106 participants (53 participants in each group).
1.Primary Outcome
Title Change From Baseline at Week 6 and Week 12 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)
Hide Description The investigator or assessor 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 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
Time Frame Baseline (Day 0), Week 6, and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) Population: all randomized and treated participants with at least one post-treatment MAS wrist score. 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 BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 53 53
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 6 -1.21  (0.616) -1.33  (0.753)
Week 12 -0.88  (0.589) -1.12  (0.752)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BOTOX in Original DB Study; BOTOX in OL Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter t-distribution
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-1.38 to -1.04
Estimation Comments Confidence intervals for means were based on the t-distribution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo in Original DB Study; BOTOX in OL Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter t-distribution
Estimated Value -1.33
Confidence Interval (2-Sided) 95%
-1.54 to -1.12
Estimation Comments Confidence intervals for means were based on the t-distribution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BOTOX in Original DB Study; BOTOX in OL Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter t-distribution
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-1.04 to -0.72
Estimation Comments Confidence intervals for means were based on the t-distribution.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo in Original DB Study; BOTOX in OL Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter t-distribution
Estimated Value -1.12
Confidence Interval (2-Sided) 95%
-1.33 to -0.91
Estimation Comments Confidence intervals for means were based on the t-distribution.
2.Secondary Outcome
Title Number of Participants Classified as Wrist Treatment Responders at Week 6 and Week 12
Hide Description Wrist treatment responders are defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS from Baseline. 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 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 BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 53 53
Measure Type: Number
Unit of Measure: participants
Week 6 43 42
Week 12 35 39
3.Secondary Outcome
Title Change From Baseline at Week 6 and Week 12 for Finger Flexor Muscle Tone as Measured on the MAS
Hide Description The investigator or assessor 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 Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
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 BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 53 53
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 6 -1.14  (0.716) -1.29  (0.769)
Week 12 -0.72  (0.607) -0.96  (0.805)
4.Secondary Outcome
Title Change From Baseline at Week 6 and Week 12 for Thumb Flexor Muscle Tone as Measured on the MAS
Hide Description The investigator or assessor 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 Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
Time Frame Baseline (Day 0), Week 6, and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population. Only those participants who had thumb spasticity were analyzed. The missing data imputation method was used for analysis.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 47
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 6 -1.02  (0.642) -1.22  (0.721)
Week 12 -0.80  (0.631) -0.92  (0.716)
5.Secondary Outcome
Title Change From Baseline at Week 6 and Week 12 for the 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 Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
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 BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 53 53
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 6 -0.64  (0.591) -0.72  (0.662)
Week 12 -0.59  (0.570) -0.57  (0.665)
6.Secondary Outcome
Title Global Assessment Scale (GAS) Score as Evaluated by the Physician at Week 6 and Week 12
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 worsening, -0=unchanged, +4=very marked improvement) at Week 6 and Week 12.
Time Frame 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 BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 53 53
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 6 1.9  (0.91) 2.2  (0.84)
Week 12 1.6  (0.82) 1.9  (0.93)
7.Secondary Outcome
Title GAS Score as Evaluated by the Care Giver or the Participant at Week 6 and Week 12
Hide Description The care giver or participant 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 Week 6 and Week 12.
Time Frame 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 BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 53 53
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 6 1.8  (0.91) 2.1  (0.85)
Week 12 1.6  (0.81) 1.7  (0.91)
8.Secondary Outcome
Title Mean Change From Baseline in Red Blood Cell (RBC) Count at the Exit Visit
Hide Description Blood samples of participants were collected and evaluated for RBC count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Time Frame Baseline (Day 0) and exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population: all enrolled and treated participants. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 44
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per Liter
-0.050  (0.3682) -0.039  (0.3087)
9.Secondary Outcome
Title Mean Change From Baseline in White Blood Cell (WBC) and Platelet Count at the Exit Visit
Hide Description Blood samples of participants were collected and evaluated for WBC count and platelet count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Time Frame Baseline (Day 0) and the exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 44
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per Liter
WBCs 0.111  (1.3340) -0.273  (2.1714)
Platelets -10.660  (38.8734) -1.386  (41.5828)
10.Secondary Outcome
Title Mean Change From Baseline in the Percentage of Neutrophils, the Percentage of Lymphocytes, the Percentage of Monocytes, the Percentage of Eosinophils, and the Percentage of Basophils at the Exit Visit
Hide Description Blood samples of participants were collected and evaluated for the percentage of neutrophils, lymphocytes, monocytes, eosinophils, and basophils comprising the total WBC count in the blood at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Time Frame Baseline (Day 0) and the exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 44
Mean (Standard Deviation)
Unit of Measure: Percentage of the total WBC
Neutrophils -0.009  (6.3905) -0.757  (7.8585)
Lymphocytes 0.118  (6.4613) 0.734  (6.7396)
Monocytes -0.217  (1.6570) 0.55  (2.7845)
Eosinophils 0.094  (1.3067) 0.49  (2.3799)
Basophils 0.032  (0.2920) 0.010  (0.2185)
11.Secondary Outcome
Title Mean Change From Baseline in Hemoglobin Content at the Exit Visit
Hide Description Blood samples of participants were collected and evaluated for hemoglobin at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Time Frame Baseline (Day 0) and the exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 44
Mean (Standard Deviation)
Unit of Measure: Grams per Liter (grams/L)
-0.255  (10.9989) -1.409  (8.7559)
12.Secondary Outcome
Title Mean Change From Baseline in Hematocrit Value at the Exit Visit
Hide Description The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Time Frame Baseline (Day 0) and the exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 44
Mean (Standard Deviation)
Unit of Measure: percentage
-0.003  (0.0254) -0.007  (0.0257)
13.Secondary Outcome
Title Mean Change From Baseline in Total Protein and Albumin Values at the Exit Visit
Hide Description Blood samples of participants were collected for a biochemical test of total protein and albumin, at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Time Frame Baseline (Day 0) and the exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 44
Mean (Standard Deviation)
Unit of Measure: grams/L
Total Protein -0.711  (5.8908) -1.484  (6.0077)
Albumin -0.400  (3.5067) -0.236  (4.4753)
14.Secondary Outcome
Title Mean Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (y-GT), and Alkaline Phosphatase (ALP) Values at the Exit Visit
Hide Description Blood samples of participants were collected and evaluated for liver function, including measuring ALT, AST, y-GT, and ALP. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Time Frame Baseline (Day 0) and the exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 44
Mean (Standard Deviation)
Unit of Measure: International Units per Liter (IU/L)
ALT, n=47, 44 -1.100  (10.9938) -0.005  (13.6079)
AST, n=47, 44 -0.153  (9.3633) -0.302  (8.2277)
y-GT, n=47, 44 -1.098  (14.0099) 0.316  (17.4397)
ALP, n=46, 44 -3.087  (10.4821) -4.225  (17.2055)
15.Secondary Outcome
Title Mean Change From Baseline in Serum Creatinine, Uric Acid, and Total Bilirubin Values at the Exit Visit
Hide Description Blood samples of participants were collected for a biochemical test of creatine, uric acid, and total bilirubin. Creatine and uric acid are evaluated for kidney function. The liver function test includes total bilirubin. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Time Frame Baseline (Day 0) and the exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 44
Mean (Standard Deviation)
Unit of Measure: Micromoles per Liter (μmol/L)
Creatinine -1.509  (9.8783) -0.984  (20.1303)
Uric Acid -3.670  (61.1350) -16.198  (67.7636)
Total Bilirubin 0.249  (4.6873) -0.293  (3.6399)
16.Secondary Outcome
Title Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit
Hide Description Blood samples of participants were collected for biochemical tests of BUN, FBG, electrolytes, cholesterol, and triglycerides. The BUN test is primarily used to evaluate kidney function. Electrolytes include sodium, potassium, and chloride. Change from Baseline was calculated as the value at the exit visit minus the value at Baseline.
Time Frame Baseline (Day 0) and the exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 44
Mean (Standard Deviation)
Unit of Measure: Millimoles per Liter (mmol/L)
BUN, n=47, 44 -0.292  (1.1855) 0.226  (2.9929)
FBG, n=47, 43 0.209  (1.3513) -0.081  (0.8000)
Sodium, n=47, 44 0.423  (3.5990) -0.034  (2.7857)
Potassium, n=47, 44 -0.008  (0.4014) -0.060  (0.5128)
Chloride, n=47, 44 1.077  (4.0509) -0.143  (3.4336)
Total cholesterol, n=47, 43 -0.057  (0.8410) 0.282  (0.9535)
Triglycerides, n=47, 43 -0.039  (0.6525) 0.119  (0.5698)
17.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
Hide Description Urine samples of participants were collected for urinalysis, including measuring protein, blood, leukocyte, glucose, and urobilinogen. All values out of the normal range were evaluated by the investigator. Classification of clinically significant and not clinically significant was based on the investigator’s clinical judgment; no specific criteria were used.
Time Frame Screening visit (-Week 1) and the exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population. Only those participants for whom data were available for both the Screening and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 44
Measure Type: Number
Unit of Measure: participants
Urine protein, Screening 0 0
Urine protein, Exit visit 0 0
Blood, Screening 0 3
Blood, Exit visit 0 1
Leukocytes, Screening 1 3
Leukocytes, Exit visit 1 0
Urine glucose, Screeing 2 3
Urine glucose, Exit visit 0 2
Urobilinogen, Screening 0 0
Urobilinogen, Exit visit 0 0
18.Secondary Outcome
Title Mean Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at the Exit Visit
Hide Description Systolic blood pressure (SBP) and diastolic BP of participants were measured in the sitting position. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Time Frame Baseline (Day 0) and the exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 46
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
Systolic BP -3.1  (8.96) -2.3  (10.02)
Diastolic BP -1.4  (6.27) -2.5  (7.79)
19.Secondary Outcome
Title Mean Change From Baseline in Pulse Rate at the Exit Visit
Hide Description The pulse rate of participants was recorded. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Time Frame Baseline (Screening) and the exit visit (Week 12 or earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description:
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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).
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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 47 46
Mean (Standard Deviation)
Unit of Measure: beats per minute
-3.0  (9.27) 1.0  (8.49)
Time Frame Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Adverse Event Reporting Description Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
 
Arm/Group Title BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Hide Arm/Group Description Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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). Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 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
BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Affected / at Risk (%) Affected / at Risk (%)
Total   1/53 (1.89%)   0/56 (0.00%) 
Congenital, familial and genetic disorders     
Cerebral arteriovenous malformation haemorrhagic  1  1/53 (1.89%)  0/56 (0.00%) 
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%
BOTOX in Original DB Study; BOTOX in OL Study Placebo in Original DB Study; BOTOX in OL Study
Affected / at Risk (%) Affected / at Risk (%)
Total   4/53 (7.55%)   7/56 (12.50%) 
Blood and lymphatic system disorders     
Leukopenia  1  1/53 (1.89%)  0/56 (0.00%) 
Cardiac disorders     
Palpitations  1  0/53 (0.00%)  1/56 (1.79%) 
Gastrointestinal disorders     
Constipation  1  0/53 (0.00%)  1/56 (1.79%) 
Investigations     
Aspartate aminotransferase increased  1  1/53 (1.89%)  0/56 (0.00%) 
Blood bilirubin increased  1  1/53 (1.89%)  0/56 (0.00%) 
Blood glucose increased  1  1/53 (1.89%)  0/56 (0.00%) 
Blood potassium increased  1  1/53 (1.89%)  0/56 (0.00%) 
Protein total decreased  1  0/53 (0.00%)  1/56 (1.79%) 
Renal function test abnormal  1  0/53 (0.00%)  1/56 (1.79%) 
Metabolism and nutrition disorders     
Hyperlipidaemia  1  2/53 (3.77%)  3/56 (5.36%) 
Dyslipidaemia  1  0/53 (0.00%)  1/56 (1.79%) 
Hyperuricaemia  1  0/53 (0.00%)  1/56 (1.79%) 
Hypokalaemia  1  0/53 (0.00%)  1/56 (1.79%) 
Nervous system disorders     
Epilepsy  1  1/53 (1.89%)  0/56 (0.00%) 
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: NCT01205451     History of Changes
Other Study ID Numbers: 114609
First Submitted: September 3, 2010
First Posted: September 20, 2010
Results First Submitted: July 19, 2012
Results First Posted: September 24, 2012
Last Update Posted: February 28, 2017