Comparison · NCT01392300-87a88aef
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
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT01392300-87a88aef. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01392300-87a88aef
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.304 | 0.24 | 0.377 | wilson | |
| Risk in group 2 | 0.239 | 0.162 | 0.337 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0655 | -0.0523 | 0.171 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.27 | 0.823 | 1.97 | log | |
| Odds ratio, group 1 over group 2 | 1.39 | 0.774 | 2.51 | log | |
| Number needed to treat, for one more participant with the outcome on Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) than on Double-blind Placebo Comparator | 15.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) | IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment | 52 | 171 | OG000 |
| Group 2 | Double-blind Placebo Comparator | Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment | 21 | 88 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow
- Description
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.
- Time frame
- Week 12
- Population
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).
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
- NCT number
- NCT01392300
- Phases
- PHASE3
- Conditions
- Post-stroke Spasticity of the Upper Limb
- Interventions
- IncobotulinumtoxinA (400 Units), Placebo Comparator
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Results first posted
- 2016-02-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01392300?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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