Trial · NCT01575054
BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
NCT01575054, Phase 3, Completed, Allergan; results first posted 2016-02-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity. Trials, record NCT01575054. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01575054
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
- NCT number
- NCT01575054
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 468 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Muscle Spasticity
- Interventions
- botulinum toxin Type A, Normal Saline
- First posted
- 2012-04-11
- Last updated
- 2016-09-28
- Other registries' IDs
- eudract:2011-004980-63
- Results first posted
- 2016-02-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale | Baseline, 6 Weeks | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the ankle flexors by passively moving the ankle plantar flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
| Secondary | Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale | Baseline, 6 weeks | The CGI is a 9-point scale evaluating change from baseline status by the Physician. Scores range from +4 (very marked improvement) to -4 (very marked worsening). The average of the weeks 4 and 6 CGI by Physician score is used as a secondary end point. Higher scores indicate a greater improvement from baseline. |
| Secondary | Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS) | Week 8 | The physician-assessed GAS is an individualized, goal-oriented 6-point scale used to track functional improvement toward active and passive goals. GAS scoring ranged from -3 to 2 (-3 = worse than start; 0 = expected goal/attained the defined therapeutic goal; 2 = much more than expected/improvements clearly exceeded the defined therapeutic goal). Active and Passive Goal scores are presented. |
| Secondary | Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale | Baseline, Week 6 | The patient is asked to select a number that best describes his/her pain while walking on an 11-point scale from 0 = "no pain" to 10 = "pain as bad as can be imagined". Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score \>0 are included in the analyses. |
| Secondary | Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale | Baseline, Week 6 | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the optional muscles by passively moving the muscles through their range of motion. Optional muscles treated include: Rectus Femoris, Flexor Digitorum Longus, Flexor Hallucis Longus, and Extensor Hallucis. The scores range from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale | Baseline, 6 Weeks | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale | Baseline, 6 weeks | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS) | Week 8 | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale | Baseline, Week 6 | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale | Baseline, Week 6 | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Scores on a Scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale | Botulinum Toxin Type A | Baseline | 4.1 | Standard Deviation 0.27 | Scores on a Scale |
| Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale | Normal Saline (Placebo) Followed by Botulinum Toxin Type A | Baseline | 4.1 | Standard Deviation 0.25 | Scores on a Scale |
| Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale | Botulinum Toxin Type A | Change from Baseline at 6 weeks | -0.81 | Standard Deviation 0.874 | Scores on a Scale |
| Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale | Normal Saline (Placebo) Followed by Botulinum Toxin Type A | Change from Baseline at 6 weeks | -0.61 | Standard Deviation 0.835 | Scores on a Scale |
| Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale | Botulinum Toxin Type A | 0.86 | Standard Deviation 0.953 | Scores on a Scale | |
| Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale | Normal Saline (Placebo) Followed by Botulinum Toxin Type A | 0.65 | Standard Deviation 0.902 | Scores on a Scale | |
| Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS) | Botulinum Toxin Type A | Active Goals (N=226, 228) | -0.8 | Standard Deviation 1.34 | Scores on a Scale |
| Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS) | Normal Saline (Placebo) Followed by Botulinum Toxin Type A | Active Goals (N=226, 228) | -1.0 | Standard Deviation 1.33 | Scores on a Scale |
| Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS) | Botulinum Toxin Type A | Passive Goals--use (N=214, 217) | -0.5 | Standard Deviation 1.42 | Scores on a Scale |
| Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS) | Normal Saline (Placebo) Followed by Botulinum Toxin Type A | Passive Goals--use (N=214, 217) | -0.8 | Standard Deviation 1.33 | Scores on a Scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Botulinum Toxin Type A | 233 | |
| Overall Study | STARTED | Normal Saline (Placebo) Followed by Botulinum Toxin Type A | 235 | |
| Overall Study | COMPLETED | Botulinum Toxin Type A | 204 | |
| Overall Study | COMPLETED | Normal Saline (Placebo) Followed by Botulinum Toxin Type A | 209 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Type A | 29 | |
| Overall Study | NOT COMPLETED | Normal Saline (Placebo) Followed by Botulinum Toxin Type A | 26 |
Source ClinicalTrials.gov
Adverse events60
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 |
|---|---|---|---|---|---|---|
| serious | Bifascicular block | Cardiac disorders | Botulinum Toxin Type A | 0 | 231 | |
| serious | Bifascicular block | Cardiac disorders | Normal Saline (Placebo) | 1 | 233 | |
| serious | Bradycardia | Cardiac disorders | Botulinum Toxin Type A | 0 | 231 | |
| serious | Bradycardia | Cardiac disorders | Normal Saline (Placebo) | 1 | 233 | |
| serious | Bundle branch block left | Cardiac disorders | Botulinum Toxin Type A | 0 | 231 | |
| serious | Bundle branch block left | Cardiac disorders | Normal Saline (Placebo) | 1 | 233 | |
| serious | Bundle branch block right | Cardiac disorders | Botulinum Toxin Type A | 0 | 231 | |
| serious | Bundle branch block right | Cardiac disorders | Normal Saline (Placebo) | 1 | 233 | |
| serious | Coronary artery disease | Cardiac disorders | Botulinum Toxin Type A | 0 | 231 | |
| serious | Coronary artery disease | Cardiac disorders | Normal Saline (Placebo) | 1 | 233 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botulinum Toxin Type A | ||
| Total, all-cause mortality | Normal Saline (Placebo) | ||
| Total, other adverse events | Botulinum Toxin Type A | 0 | 231 |
| Total, other adverse events | Normal Saline (Placebo) | 0 | 233 |
| Total, serious adverse events | Botulinum Toxin Type A | 10 | 231 |
| Total, serious adverse events | Normal Saline (Placebo) | 9 | 233 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29330071 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Botulinum Toxin Type A vs Normal Saline (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/NCT01575054
GET https://conductscience.org/api/trials/v1/NCT01575054/results?page=2