Comparison · NCT01392300-e2eb70ba
Double-blind IncobotulinumtoxinA (Xeomin) (400 Units) vs Double-blind Placebo Comparator: Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern
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 Primary Target Clinical Pattern. Trial comparisons, record NCT01392300-e2eb70ba. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01392300-e2eb70ba
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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 | 0.398 | 0.327 | 0.472 | wilson | |
| Risk in group 2 | 0.25 | 0.171 | 0.35 | wilson | |
| Risk difference, group 1 minus group 2 | 0.148 | 0.0257 | 0.256 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.59 | 1.06 | 2.39 | log | |
| Odds ratio, group 1 over group 2 | 1.98 | 1.12 | 3.51 | 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 | 6.77 | 3.9 | 38.9 | from the risk difference interval |
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 | 68 | 171 | OG000 |
| Group 2 | Double-blind Placebo Comparator | Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment | 22 | 88 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern
- Description
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.
- 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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