Trial · NCT00465738
IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
NCT00465738, Phase 3, Completed, Merz Pharmaceuticals GmbH; results first posted 2010-12-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity. Trials, record NCT00465738. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00465738
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
- NCT number
- NCT00465738
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 216 participants, actual
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Conditions
- Upper Limb Spasticity
- Interventions
- incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
- First posted
- 2007-04-25
- Last updated
- 2010-12-31
- Results first posted
- 2010-12-06
Source ClinicalTrials.gov
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set | At week 4 | The primary efficacy endpoint is the number of responder at Week 4; response defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit to Week 4. The DAS determines the functional impairment for the domains hygiene, dressing, limb position and pain according to the following scale: 0 = no disability; 1 = mild disability; 2 = moderate disability; 3 = severe disability. At Screening visit, the subject and investigator, selected together one of the four domains as the primary therapeutic target. |
| Secondary | Responder in DAS at Week 4 - Full Analysis Set | week 4 | Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit. |
| Secondary | Responder in DAS at Week 12 - Full Analysis Set | week 12 | Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit. |
| Secondary | Responder in DAS at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit. |
| Secondary | Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set | Week 4 | Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5. |
| Secondary | Responder in FAT at Week 12 - Full Analysis Set | Week 12 | Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5. |
| Secondary | Responder in FAT at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5. |
| Secondary | Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set | week 4 | 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. |
| Secondary | Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set | week 12 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set | At week 4 | Analysis is based on Per Protocol Set, defined as all randomized subjects who received at least one dose of study drug and who have no major deviation from study protocol. For this set of subjects no missing values can occur for the primary endpoint. | participants | NUMBER |
| SECONDARY | Responder in DAS at Week 4 - Full Analysis Set | week 4 | 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. | participants | NUMBER |
| SECONDARY | Responder in DAS at Week 12 - Full Analysis Set | week 12 | 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. | participants | NUMBER |
| SECONDARY | Responder in DAS at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | 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. | participants | NUMBER |
| SECONDARY | Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set | Week 4 | 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. | participants | NUMBER |
| SECONDARY | Responder in FAT at Week 12 - Full Analysis Set | Week 12 | 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. | participants | NUMBER |
| SECONDARY | Responder in FAT at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | 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. | participants | NUMBER |
| SECONDARY | Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set | week 4 | 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. | participants | NUMBER |
| SECONDARY | Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set | week 12 | 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. | participants | NUMBER |
| SECONDARY | Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | 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. | participants | NUMBER |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 51 | participants | ||
| Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 44 | participants | ||
| Responder in DAS at Week 4 - Full Analysis Set | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 59 | participants | ||
| Responder in DAS at Week 4 - Full Analysis Set | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 49 | participants | ||
| Responder in DAS at Week 12 - Full Analysis Set | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 46 | participants | ||
| Responder in DAS at Week 12 - Full Analysis Set | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 38 | participants | ||
| Responder in DAS at Follow up - Full Analysis Set | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 40 | participants | ||
| Responder in DAS at Follow up - Full Analysis Set | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 33 | participants | ||
| Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 17 | participants | ||
| Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 24 | participants |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 97 | |
| Overall Study | STARTED | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 95 | |
| Overall Study | COMPLETED | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 91 | |
| Overall Study | COMPLETED | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 89 | |
| Overall Study | NOT COMPLETED | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 6 | |
| Overall Study | NOT COMPLETED | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 6 |
Source ClinicalTrials.gov
Adverse events58
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 | Bronchitis | Infections and infestations | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 0 | 96 | |
| other | Bronchitis | Infections and infestations | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 2 | 96 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 2 | 96 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 0 | 96 | |
| other | Diarrhoea | Gastrointestinal disorders | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 2 | 96 | |
| other | Diarrhoea | Gastrointestinal disorders | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 1 | 96 | |
| other | Epilepsy | Nervous system disorders | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 3 | 96 | |
| other | Epilepsy | Nervous system disorders | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 1 | 96 | |
| other | Fall | Injury, poisoning and procedural complications | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 0 | 96 | |
| other | Fall | Injury, poisoning and procedural complications | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 2 | 96 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | ||
| Total, all-cause mortality | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | ||
| Total, other adverse events | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 15 | 96 |
| Total, other adverse events | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 17 | 96 |
| Total, serious adverse events | incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL | 6 | 96 |
| Total, serious adverse events | incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL | 6 | 96 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons38
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
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 Toilet Use | Trial comparisons |
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 Week 4 - Item Toilet Use | Trial comparisons |
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 Week 4 - Item Bathing/Showering | Trial comparisons |
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 Week 12 - Item Toilet Use | Trial comparisons |
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 Feeding | Trial comparisons |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL vs incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL: Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set | Trial comparisons |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL vs incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL: Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set | Trial comparisons |
| incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL vs incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL: Responder in DAS at Follow up - Full Analysis Set | Trial comparisons |
incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL vs incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL: Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set | Trial comparisons |
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 Bathing/Showering | Trial comparisons |
1 to 10 of 38
See all 38 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/NCT00465738
GET https://conductscience.org/api/trials/v1/NCT00465738/registered?page=2