Trial · NCT00460655
Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity
NCT00460655, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity. Trials, record NCT00460655. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00460655
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity
- NCT number
- NCT00460655
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 120 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Post-Stroke Spasticity, Cerebrovascular Accident
- Interventions
- GSK1358820, Placebo
- First posted
- 2007-04-16
- Last updated
- 2010-09-08
- Results first posted
- 2010-01-26
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12) | Baseline, Week 12 | Change from baseline in MAS ankle score using a 6-point scale (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) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS ankle score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS ankle score. Negative changes from baseline indicate improvement, and the AUC has a negative sign. |
| Secondary | Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part\[s\] rigid in flexion or extension) at each time point in the double-blind phase. The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder \[less than half\] of ROM \[range of motion\]) of MAS score is regarded as score 1.5. |
| Secondary | Mean Change From Baseline in the Physician's Rating Score (PRS) From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point in double-blind phase. |
| Secondary | Mean Change From Baseline in the Time (Seconds) to Walk 10 Meters From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | The time (seconds) required to walk 10 meters was measured at each time point in the double-blind phase. |
| Secondary | Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase. |
| Secondary | Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase |
| Secondary | Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase |
| Secondary | Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Ankle Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) | The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part\[s\] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to Week 48. The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder \[less than half\] of ROM \[range of motion\]) of MAS score is regarded as score 1.5. |
| Secondary | Mean Change From Baseline (at the Start of the Double-blind Phase) in the Physician's Rating Score (PRS) at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) | The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point from baseline (at the start of the double-blind phase) to Week 48. |
| Secondary | Mean Change From Baseline (at the Start of the Double-blind Phase) in the Time (Seconds) to Walk 10 Meters at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) | The time (seconds) required to walk 10 meters was measured at each time point from baseline (at the start of the double-blind phase) to Week 48. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12) | Baseline, Week 12 | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Score*week | MEAN |
| SECONDARY | Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Physician's Rating Score (PRS) From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Time (Seconds) to Walk 10 Meters From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | seconds | MEAN |
| SECONDARY | Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Ankle Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (at the Start of the Double-blind Phase) in the Physician's Rating Score (PRS) at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (at the Start of the Double-blind Phase) in the Time (Seconds) to Walk 10 Meters at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | seconds | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group170
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12) | BTX 300U | -8.513 | Standard Deviation 6.6904 | Score*week | |
| Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12) | Placebo | -5.085 | Standard Deviation 6.6496 | Score*week | |
| Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | BTX 300U | Week 1 | -0.61 | Standard Deviation 0.675 | Points on a scale |
| Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | Placebo | Week 1 | -0.52 | Standard Deviation 0.765 | Points on a scale |
| Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | BTX 300U | Week 4 | -0.88 | Standard Deviation 0.687 | Points on a scale |
| Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | Placebo | Week 4 | -0.43 | Standard Deviation 0.718 | Points on a scale |
| Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | BTX 300U | Week 6 | -0.91 | Standard Deviation 0.733 | Points on a scale |
| Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | Placebo | Week 6 | -0.47 | Standard Deviation 0.712 | Points on a scale |
| Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | BTX 300U | Week 8 | -0.82 | Standard Deviation 0.660 | Points on a scale |
| Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | Placebo | Week 8 | -0.43 | Standard Deviation 0.676 | Points on a scale |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Phase (12 Weeks) | STARTED | BTX 300U | 58 | |
| Double-Blind Phase (12 Weeks) | STARTED | Placebo | 62 | |
| Double-Blind Phase (12 Weeks) | STARTED | DB BTX + OL BTX | 0 | |
| Double-Blind Phase (12 Weeks) | STARTED | DB Placebo + OL BTX | 0 | |
| Double-Blind Phase (12 Weeks) | COMPLETED | BTX 300U | 52 | |
| Double-Blind Phase (12 Weeks) | COMPLETED | Placebo | 61 | |
| Double-Blind Phase (12 Weeks) | COMPLETED | DB BTX + OL BTX | 0 | |
| Double-Blind Phase (12 Weeks) | COMPLETED | DB Placebo + OL BTX | 0 | |
| Double-Blind Phase (12 Weeks) | NOT COMPLETED | BTX 300U | 6 | |
| Double-Blind Phase (12 Weeks) | NOT COMPLETED | Placebo | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events104
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 | Nasopharyngitis | Infections and infestations | BTX 300U | 8 | 58 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 12 | 62 | |
| other | Nasopharyngitis | Infections and infestations | DB BTX + OL BTX | 15 | 50 | |
| other | Nasopharyngitis | Infections and infestations | DB Placebo + OL BTX | 6 | 57 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | BTX 300U | 2 | 58 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Placebo | 2 | 62 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | DB BTX + OL BTX | 3 | 50 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | DB Placebo + OL BTX | 0 | 57 | |
| other | Injection site pain | General disorders | BTX 300U | 3 | 58 | |
| other | Injection site pain | General disorders | Placebo | 1 | 62 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BTX 300U | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | DB BTX + OL BTX | ||
| Total, all-cause mortality | DB Placebo + OL BTX | ||
| Total, other adverse events | BTX 300U | 16 | 58 |
| Total, other adverse events | Placebo | 16 | 62 |
| Total, other adverse events | DB BTX + OL BTX | 23 | 50 |
| Total, other adverse events | DB Placebo + OL BTX | 16 | 57 |
| Total, serious adverse events | BTX 300U | 5 | 58 |
| Total, serious adverse events | Placebo | 1 | 62 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20358216 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00460655
GET https://conductscience.org/api/trials/v1/NCT00460655/results?page=2