Trial Outcomes & Findings for 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 (NCT NCT01153815)
NCT ID: NCT01153815
Last Updated: 2017-06-28
Results Overview
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.
COMPLETED
PHASE3
170 participants
Baseline (Day 0) and Week 6
2017-06-28
Participant Flow
Participant milestones
| Measure |
Placebo
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).
|
BTX 200 U
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 Study
STARTED
|
83
|
87
|
|
Overall Study
COMPLETED
|
74
|
82
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
Placebo
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).
|
BTX 200 U
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 Study
Adverse Event
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Placebo
n=83 Participants
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).
|
BTX 200 U
n=87 Participants
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
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 Years
STANDARD_DEVIATION 12.23 • n=99 Participants
|
55.4 Years
STANDARD_DEVIATION 10.69 • n=107 Participants
|
55.8 Years
STANDARD_DEVIATION 11.44 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
83 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) and Week 6Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=83 Participants
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).
|
BTX 200 U
n=87 Participants
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).
|
|---|---|---|
|
Change From Baseline at Week 6 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)
|
-0.56 scores on a scale
Standard Deviation 0.735
|
-1.21 scores on a scale
Standard Deviation 0.936
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Week 6, and Week 12Population: FAS Population. The missing data imputation method was used for analysis.
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.
Outcome measures
| Measure |
Placebo
n=83 Participants
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).
|
BTX 200 U
n=87 Participants
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).
|
|---|---|---|
|
Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score
Week 6
|
-2.341 scores on a scale
Standard Deviation 2.8894
|
-5.672 scores on a scale
Standard Deviation 4.3340
|
|
Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score
Week 12
|
-5.618 scores on a scale
Standard Deviation 6.5412
|
-12.712 scores on a scale
Standard Deviation 9.0510
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Weeks 1, 4, 8, and 12Population: FAS Population. The missing data imputation method was used for analysis.
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.
Outcome measures
| Measure |
Placebo
n=83 Participants
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).
|
BTX 200 U
n=87 Participants
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).
|
|---|---|---|
|
Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS
Week 1
|
-0.31 scores on a scale
Standard Deviation 0.504
|
-0.80 scores on a scale
Standard Deviation 0.752
|
|
Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS
Week 4
|
-0.46 scores on a scale
Standard Deviation 0.581
|
-1.14 scores on a scale
Standard Deviation 0.843
|
|
Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS
Week 8
|
-0.59 scores on a scale
Standard Deviation 0.757
|
-1.27 scores on a scale
Standard Deviation 0.926
|
|
Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS
Week 12
|
-0.48 scores on a scale
Standard Deviation 0.640
|
-1.01 scores on a scale
Standard Deviation 0.822
|
SECONDARY outcome
Timeframe: Weeks 1, 4, 6, 8, and 12Population: FAS Population. The missing data imputation method was used for analysis.
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).
Outcome measures
| Measure |
Placebo
n=83 Participants
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).
|
BTX 200 U
n=87 Participants
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).
|
|---|---|---|
|
Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits
Week 6
|
36 participants
|
62 participants
|
|
Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits
Week 8
|
36 participants
|
64 participants
|
|
Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits
Week 1
|
24 participants
|
51 participants
|
|
Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits
Week 4
|
33 participants
|
63 participants
|
|
Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits
Week 12
|
23 participants
|
54 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12Population: FAS Population. The missing data imputation method was used for analysis.
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.
Outcome measures
| Measure |
Placebo
n=83 Participants
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).
|
BTX 200 U
n=87 Participants
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).
|
|---|---|---|
|
Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS
Week 8
|
-0.45 scores on a scale
Standard Deviation 0.683
|
-1.04 scores on a scale
Standard Deviation 0.834
|
|
Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS
Week 12
|
-0.28 scores on a scale
Standard Deviation 0.639
|
-0.73 scores on a scale
Standard Deviation 0.773
|
|
Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS
Week 1
|
-0.30 scores on a scale
Standard Deviation 0.552
|
-0.67 scores on a scale
Standard Deviation 0.769
|
|
Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS
Week 4
|
-0.37 scores on a scale
Standard Deviation 0.654
|
-0.98 scores on a scale
Standard Deviation 0.848
|
|
Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS
Week 6
|
-0.42 scores on a scale
Standard Deviation 0.718
|
-1.05 scores on a scale
Standard Deviation 0.879
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=66 Participants
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).
|
BTX 200 U
n=57 Participants
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).
|
|---|---|---|
|
Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS
Week 1
|
-0.33 scores on a scale
Standard Deviation 0.546
|
-0.85 scores on a scale
Standard Deviation 0.841
|
|
Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS
Week 4
|
-0.44 scores on a scale
Standard Deviation 0.655
|
-1.02 scores on a scale
Standard Deviation 0.820
|
|
Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS
Week 6
|
-0.53 scores on a scale
Standard Deviation 0.758
|
-1.06 scores on a scale
Standard Deviation 0.844
|
|
Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS
Week 8
|
-0.51 scores on a scale
Standard Deviation 0.804
|
-1.06 scores on a scale
Standard Deviation 0.861
|
|
Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS
Week 12
|
-0.43 scores on a scale
Standard Deviation 0.759
|
-0.80 scores on a scale
Standard Deviation 0.797
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12Population: FAS Population. The missing data imputation method was used for analysis.
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.
Outcome measures
| Measure |
Placebo
n=83 Participants
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).
|
BTX 200 U
n=87 Participants
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).
|
|---|---|---|
|
Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS)
Week 1
|
-0.13 scores on a scale
Standard Deviation 0.406
|
-0.32 scores on a scale
Standard Deviation 0.560
|
|
Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS)
Week 4
|
-0.18 scores on a scale
Standard Deviation 0.446
|
-0.49 scores on a scale
Standard Deviation 0.663
|
|
Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS)
Week 6
|
-0.28 scores on a scale
Standard Deviation 0.548
|
-0.54 scores on a scale
Standard Deviation 0.696
|
|
Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS)
Week 8
|
-0.29 scores on a scale
Standard Deviation 0.594
|
-0.59 scores on a scale
Standard Deviation 0.708
|
|
Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS)
Week 12
|
-0.29 scores on a scale
Standard Deviation 0.571
|
-0.53 scores on a scale
Standard Deviation 0.676
|
SECONDARY outcome
Timeframe: Weeks 1, 4, 6, 8, and 12Population: FAS Population. The missing data imputation method was used for analysis.
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.
Outcome measures
| Measure |
Placebo
n=83 Participants
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).
|
BTX 200 U
n=87 Participants
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).
|
|---|---|---|
|
Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points
Week 1
|
0.5 scores on a scale
Standard Deviation 0.80
|
1.2 scores on a scale
Standard Deviation 1.01
|
|
Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points
Week 4
|
0.7 scores on a scale
Standard Deviation 0.94
|
1.5 scores on a scale
Standard Deviation 1.08
|
|
Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points
Week 6
|
0.7 scores on a scale
Standard Deviation 1.04
|
1.5 scores on a scale
Standard Deviation 1.12
|
|
Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points
Week 8
|
0.7 scores on a scale
Standard Deviation 0.98
|
1.4 scores on a scale
Standard Deviation 1.08
|
|
Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points
Week 12
|
0.6 scores on a scale
Standard Deviation 0.86
|
1.2 scores on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Weeks 1, 4, 6, 8, and 12Population: FAS Population. The missing data imputation method was used for analysis.
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.
Outcome measures
| Measure |
Placebo
n=83 Participants
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).
|
BTX 200 U
n=87 Participants
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).
|
|---|---|---|
|
GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points
Week 12
|
0.5 scores on a scale
Standard Deviation 0.85
|
1.2 scores on a scale
Standard Deviation 1.02
|
|
GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points
Week 1
|
0.6 scores on a scale
Standard Deviation 0.81
|
1.1 scores on a scale
Standard Deviation 1.05
|
|
GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points
Week 4
|
0.7 scores on a scale
Standard Deviation 0.93
|
1.4 scores on a scale
Standard Deviation 1.14
|
|
GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points
Week 6
|
0.7 scores on a scale
Standard Deviation 1.06
|
1.5 scores on a scale
Standard Deviation 1.13
|
|
GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points
Week 8
|
0.7 scores on a scale
Standard Deviation 0.99
|
1.5 scores on a scale
Standard Deviation 1.08
|
Adverse Events
Placebo
BTX 200 U
Serious adverse events
| Measure |
Placebo
n=83 participants at risk
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).
|
BTX 200 U
n=87 participants at risk
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).
|
|---|---|---|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/83
|
1.1%
1/87
|
|
Nervous system disorders
Convulsion
|
0.00%
0/83
|
1.1%
1/87
|
|
Injury, poisoning and procedural complications
Wound
|
1.2%
1/83
|
0.00%
0/87
|
Other adverse events
| Measure |
Placebo
n=83 participants at risk
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).
|
BTX 200 U
n=87 participants at risk
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).
|
|---|---|---|
|
Investigations
Blood bilirubin increased
|
0.00%
0/83
|
1.1%
1/87
|
|
Investigations
Blood urea increased
|
0.00%
0/83
|
1.1%
1/87
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.2%
1/83
|
1.1%
1/87
|
|
Investigations
Lipids abnormal
|
0.00%
0/83
|
1.1%
1/87
|
|
Investigations
Platelet count decreased
|
0.00%
0/83
|
1.1%
1/87
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/83
|
0.00%
0/87
|
|
Investigations
Blood cholesterol increased
|
1.2%
1/83
|
0.00%
0/87
|
|
Investigations
Blood glucose increased
|
2.4%
2/83
|
0.00%
0/87
|
|
Investigations
Blood potassium increased
|
1.2%
1/83
|
0.00%
0/87
|
|
Investigations
Blood triglycerides increased
|
1.2%
1/83
|
0.00%
0/87
|
|
Investigations
Liver function test abnormal
|
2.4%
2/83
|
0.00%
0/87
|
|
Investigations
Platelet count abnormal
|
1.2%
1/83
|
0.00%
0/87
|
|
Investigations
Urine analysis abnormal
|
1.2%
1/83
|
0.00%
0/87
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
1.2%
1/83
|
2.3%
2/87
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/83
|
1.1%
1/87
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.2%
1/83
|
1.1%
1/87
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.2%
1/83
|
0.00%
0/87
|
|
Nervous system disorders
Epilepsy
|
2.4%
2/83
|
1.1%
1/87
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/83
|
1.1%
1/87
|
|
Infections and infestations
Varicella
|
0.00%
0/83
|
1.1%
1/87
|
|
Infections and infestations
Erysipelas
|
1.2%
1/83
|
0.00%
0/87
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
1/83
|
0.00%
0/87
|
|
Infections and infestations
Pneumonia
|
1.2%
1/83
|
0.00%
0/87
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/83
|
0.00%
0/87
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/83
|
1.1%
1/87
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/83
|
1.1%
1/87
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
1/83
|
1.1%
1/87
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/83
|
0.00%
0/87
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/83
|
0.00%
0/87
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/83
|
1.1%
1/87
|
|
Injury, poisoning and procedural complications
Head injury
|
1.2%
1/83
|
0.00%
0/87
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/83
|
1.1%
1/87
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
2/83
|
1.1%
1/87
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/83
|
0.00%
0/87
|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/83
|
0.00%
0/87
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
1/83
|
0.00%
0/87
|
|
General disorders
Pyrexia
|
2.4%
2/83
|
0.00%
0/87
|
|
Immune system disorders
Hypersensitivity
|
1.2%
1/83
|
0.00%
0/87
|
|
Renal and urinary disorders
Renal failure
|
1.2%
1/83
|
0.00%
0/87
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER