Comparison · NCT00465738-430d097c
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL vs incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL: Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing
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: Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing. Trial comparisons, record NCT00465738-430d097c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00465738-430d097c
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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 | 0.107 | 0.055 | 0.197 | wilson | |
| Risk in group 2 | 0.0986 | 0.0486 | 0.19 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00808 | -0.0967 | 0.111 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.414 | 2.83 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.374 | 3.18 | 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 | 124 | 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 | 8 | 75 | OG000 | |
| Group 2 | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 7 | 71 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing
- Description
Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.
- Time frame
- follow up visit, between week 12 and week 20
- 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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