Trial · NCT01392300
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
NCT01392300, Phase 3, Completed, Merz Pharmaceuticals GmbH; results first posted 2016-02-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke. Trials, record NCT01392300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01392300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
- NCT number
- NCT01392300
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 317 participants, actual
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Conditions
- Post-stroke Spasticity of the Upper Limb
- Interventions
- IncobotulinumtoxinA (400 Units), Placebo Comparator
- First posted
- 2011-07-12
- Last updated
- 2017-01-16
- Other registries' IDs
- eudract:2010-023043-15
- Results first posted
- 2016-02-11
Source ClinicalTrials.gov
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern | Week 4 | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
| Primary | Investigator's Global Impression of Change | Week 4 | This is the co-primary outcome measure. The Global Impression of Change Scale \[GICS\] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved. |
| Secondary | Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern | Week 4 | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Secondary | Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern | Week 8 | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Secondary | Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern | Week 12 | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Secondary | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Secondary | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Secondary | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist | Week 12 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Secondary | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow | Week 4 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
| Secondary | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow | Week 8 | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 registered outcomesOutcomes50
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 Ashworth Scale (AS) Score of Primary Target Clinical Pattern | Week 4 | Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Investigator's Global Impression of Change | Week 4 | Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by zero change (worst case). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern | Week 4 | Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder). | participants | NUMBER |
| SECONDARY | Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern | Week 8 | Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder). | participants | NUMBER |
| SECONDARY | Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern | Week 12 | Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder). | participants | NUMBER |
| SECONDARY | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist | Week 4 | Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder). | participants | NUMBER |
| SECONDARY | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist | Week 8 | Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder). | participants | NUMBER |
| SECONDARY | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist | Week 12 | Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder). | participants | NUMBER |
| SECONDARY | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow | Week 4 | Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder). | participants | NUMBER |
| SECONDARY | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow | Week 8 | Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder). | participants | NUMBER |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 outcomesResults by group100
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 Ashworth Scale (AS) Score of Primary Target Clinical Pattern | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | -0.9 | Standard Error 0.06 | units on a scale | |
| Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern | Double-blind Placebo Comparator | -0.5 | Standard Error 0.08 | units on a scale | |
| Investigator's Global Impression of Change | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 1.2 | Standard Error 0.07 | units on a scale | |
| Investigator's Global Impression of Change | Double-blind Placebo Comparator | 0.9 | Standard Error 0.09 | units on a scale | |
| Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 119 | participants | ||
| Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern | Double-blind Placebo Comparator | 33 | participants | ||
| Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 104 | participants | ||
| Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern | Double-blind Placebo Comparator | 34 | participants | ||
| Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 68 | participants | ||
| Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern | Double-blind Placebo Comparator | 22 | participants |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Period (MP) | STARTED | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 210 | |
| Main Period (MP) | STARTED | Double-blind Placebo Comparator | 107 | |
| Main Period (MP) | STARTED | OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections) | 0 | |
| Main Period (MP) | COMPLETED | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 199 | |
| Main Period (MP) | COMPLETED | Double-blind Placebo Comparator | 100 | |
| Main Period (MP) | COMPLETED | OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections) | 0 | |
| Main Period (MP) | NOT COMPLETED | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 11 | |
| Main Period (MP) | NOT COMPLETED | Double-blind Placebo Comparator | 7 | |
| Main Period (MP) | NOT COMPLETED | OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections) | 0 | |
| Open Label Extension (OLEX) Period | STARTED | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events129
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 | Headache | Nervous system disorders | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 1 | 210 | 1 |
| other | Headache | Nervous system disorders | Double-blind Placebo Comparator | 3 | 107 | 6 |
| other | Headache | Nervous system disorders | OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections) | 3 | 296 | 6 |
| other | Blood glucose increased | Investigations | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 1 | 210 | 1 |
| other | Blood glucose increased | Investigations | Double-blind Placebo Comparator | 0 | 107 | 0 |
| other | Blood glucose increased | Investigations | OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections) | 8 | 296 | 9 |
| other | International normalised ratio increased | Investigations | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 1 | 210 | 1 |
| other | International normalised ratio increased | Investigations | Double-blind Placebo Comparator | 0 | 107 | 0 |
| other | International normalised ratio increased | Investigations | OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections) | 8 | 296 | 10 |
| other | Gamma-glutamyltransferase increased | Investigations | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 0 | 210 | 0 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | ||
| Total, all-cause mortality | Double-blind Placebo Comparator | ||
| Total, all-cause mortality | OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections) | ||
| Total, other adverse events | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 6 | 210 |
| Total, other adverse events | Double-blind Placebo Comparator | 4 | 107 |
| Total, other adverse events | OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections) | 32 | 296 |
| Total, serious adverse events | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | 7 | 210 |
| Total, serious adverse events | Double-blind Placebo Comparator | 2 | 107 |
| Total, serious adverse events | OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections) | 22 | 296 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons18
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) vs Double-blind Placebo Comparator: Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist | Trial comparisons |
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) vs Double-blind Placebo Comparator: Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow | Trial comparisons |
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) vs Double-blind Placebo Comparator: Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern | Trial comparisons |
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) vs Double-blind Placebo Comparator: Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm | Trial comparisons |
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) vs Double-blind Placebo Comparator: Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist | Trial comparisons |
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) vs Double-blind Placebo Comparator: Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist | Trial comparisons |
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) vs Double-blind Placebo Comparator: Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm | Trial comparisons |
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) vs Double-blind Placebo Comparator: Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow | Trial comparisons |
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) vs Double-blind Placebo Comparator: Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist | Trial comparisons |
| Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) vs Double-blind Placebo Comparator: Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm | Trial comparisons |
1 to 10 of 18
See all 18 trial comparisonsTests0
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/NCT01392300
GET https://conductscience.org/api/trials/v1/NCT01392300/registered?page=2