Comparison · NCT00465738-9c7e17cd
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL vs incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL: Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set
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. incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL vs incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL: Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set. Trial comparisons, record NCT00465738-9c7e17cd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00465738-9c7e17cd
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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 | 0.627 | 0.514 | 0.727 | wilson | |
| Risk in group 2 | 0.617 | 0.508 | 0.716 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00938 | -0.14 | 0.158 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.795 | 1.3 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.544 | 1.99 | log | |
| Number needed to treat, for one more participant with the outcome on incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL than on incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 107 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 47 | 75 | OG000 | |
| Group 2 | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 50 | 81 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set
- Description
Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. The Ashworth Scale is a 5-point-scale to rate to degree of spasticity: 0 = No increase in tone; 1 = Slight increase in tone giving a catch when the limb was moved in flexion or extension; 2 = More marked increase in tone, but limb easily flexed; 3 = Considerable increase in tone - passive movements difficult; 4 = Limb rigid in flexion or extension.
- Time frame
- week 4
- Population
- Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.
Source ClinicalTrials.gov
Trial
- Title
- IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
- NCT number
- NCT00465738
- Phases
- PHASE3
- Conditions
- Upper Limb Spasticity
- Interventions
- incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Results first posted
- 2010-12-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00465738?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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