Trial · NCT01153815
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
NCT01153815, Phase 3, Completed, GlaxoSmithKline; results first posted 2012-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01153815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01153815
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT01153815
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 170 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Cerebrovascular Accident
- Interventions
- GSK1358820(Botulinum toxin type A), placebo
- First posted
- 2010-06-30
- Last updated
- 2017-06-28
- Results first posted
- 2012-05-17
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at Week 6 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS) | Baseline (Day 0) and Week 6 | 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. |
| Secondary | Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score | Baseline (Day 0), Week 6, and Week 12 | 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. |
| Secondary | Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS | Baseline (Day 0) and Weeks 1, 4, 8, and 12 | 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. |
| Secondary | Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits | Weeks 1, 4, 6, 8, and 12 | 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). |
| Secondary | Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS | Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 | 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. |
| Secondary | Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS | Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 | 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. |
| Secondary | Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS) | Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 | 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. |
| Secondary | Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points | Weeks 1, 4, 6, 8, and 12 | 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. |
| Secondary | GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points | Weeks 1, 4, 6, 8, and 12 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline at Week 6 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS) | Baseline (Day 0) and Week 6 | 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. | scores on a scale | MEAN |
| SECONDARY | Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score | Baseline (Day 0), Week 6, and Week 12 | FAS Population. The missing data imputation method was used for analysis. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS | Baseline (Day 0) and Weeks 1, 4, 8, and 12 | FAS Population. The missing data imputation method was used for analysis. | scores on a scale | MEAN |
| SECONDARY | Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits | Weeks 1, 4, 6, 8, and 12 | FAS Population. The missing data imputation method was used for analysis. | participants | NUMBER |
| SECONDARY | Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS | Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 | FAS Population. The missing data imputation method was used for analysis. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS | Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 | 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. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS) | Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 | FAS Population. The missing data imputation method was used for analysis. | scores on a scale | MEAN |
| SECONDARY | Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points | Weeks 1, 4, 6, 8, and 12 | FAS Population. The missing data imputation method was used for analysis. | scores on a scale | MEAN |
| SECONDARY | GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points | Weeks 1, 4, 6, 8, and 12 | FAS Population. The missing data imputation method was used for analysis. | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline at Week 6 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS) | Placebo | -0.56 | Standard Deviation 0.735 | scores on a scale | |
| Change From Baseline at Week 6 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS) | BTX 200 U | -1.21 | Standard Deviation 0.936 | scores on a scale | |
| Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score | Placebo | Week 6 | -2.341 | Standard Deviation 2.8894 | scores on a scale |
| Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score | BTX 200 U | Week 6 | -5.672 | Standard Deviation 4.3340 | scores on a scale |
| Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score | Placebo | Week 12 | -5.618 | Standard Deviation 6.5412 | scores on a scale |
| Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score | BTX 200 U | Week 12 | -12.712 | Standard Deviation 9.0510 | scores on a scale |
| Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS | Placebo | Week 1 | -0.31 | Standard Deviation 0.504 | scores on a scale |
| Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS | BTX 200 U | Week 1 | -0.80 | Standard Deviation 0.752 | scores on a scale |
| Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS | Placebo | Week 4 | -0.46 | Standard Deviation 0.581 | scores on a scale |
| Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS | BTX 200 U | Week 4 | -1.14 | Standard Deviation 0.843 | scores on a scale |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 83 | |
| Overall Study | STARTED | BTX 200 U | 87 | |
| Overall Study | COMPLETED | Placebo | 74 | |
| Overall Study | COMPLETED | BTX 200 U | 82 | |
| Overall Study | NOT COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | BTX 200 U | 5 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood bilirubin increased | Investigations | Placebo | 0 | 83 | |
| other | Blood bilirubin increased | Investigations | BTX 200 U | 1 | 87 | |
| other | Blood urea increased | Investigations | Placebo | 0 | 83 | |
| other | Blood urea increased | Investigations | BTX 200 U | 1 | 87 | |
| other | Gamma-glutamyltransferase increased | Investigations | Placebo | 1 | 83 | |
| other | Gamma-glutamyltransferase increased | Investigations | BTX 200 U | 1 | 87 | |
| other | Lipids abnormal | Investigations | Placebo | 0 | 83 | |
| other | Lipids abnormal | Investigations | BTX 200 U | 1 | 87 | |
| other | Platelet count decreased | Investigations | Placebo | 0 | 83 | |
| other | Platelet count decreased | Investigations | BTX 200 U | 1 | 87 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | BTX 200 U | ||
| Total, other adverse events | Placebo | 21 | 83 |
| Total, other adverse events | BTX 200 U | 16 | 87 |
| Total, serious adverse events | Placebo | 1 | 83 |
| Total, serious adverse events | BTX 200 U | 2 | 87 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| BTX 200 U vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01153815
GET https://conductscience.org/api/trials/v1/NCT01153815/results?page=2