Trial · NCT00407030
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
NCT00407030, Phase 3, Completed, Merz Pharmaceuticals GmbH; results first posted 2010-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia. Trials, record NCT00407030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00407030
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
- NCT number
- NCT00407030
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 233 participants, actual
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Conditions
- Cervical Dystonia
- Interventions
- incobotulinumtoxinA (Xeomin) (240 Units), incobotulinumtoxinA (Xeomin) (120 Units), Placebo
- First posted
- 2006-12-04
- Last updated
- 2013-07-19
- Results first posted
- 2010-12-31
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo | Baseline, week 4 | The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Primary | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo | Baseline, week 4 | The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Primary | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units) | Baseline, week 4 | The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Change From Baseline in the TWSTRS-Total Score | Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period) | The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Change From Baseline in the TWSTRS Disability Subscore | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) | TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Change From Baseline in the TWSTRS Severity Subscore | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) | TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Change From Baseline in the TWSTRS Pain Subscore | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) | TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Patient Evaluation of Global Response (PEGR) at Final Visit | Final visit (up to 20 weeks after injection of the Main Period) | The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo | Baseline, week 4 | Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the TWSTRS-Total Score | Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period) | Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value | points on a scale | MEAN |
| SECONDARY | Change From Baseline in the TWSTRS Disability Subscore | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) | Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value | points on a scale | MEAN |
| SECONDARY | Change From Baseline in the TWSTRS Severity Subscore | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) | Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value | points on a scale | MEAN |
| SECONDARY | Change From Baseline in the TWSTRS Pain Subscore | Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period) | Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value | points on a scale | MEAN |
| SECONDARY | Patient Evaluation of Global Response (PEGR) at Final Visit | Final visit (up to 20 weeks after injection of the Main Period) | Intention to treat population with missing values imputed by no effect | points on a scale | MEAN |
| PRIMARY | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo | Baseline, week 4 | Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value | points on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units) | Baseline, week 4 | Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value | points on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo | incobotulinumtoxinA (Xeomin) (240 Units) | -7.3 | Standard Error 2.18 | points on a scale | |
| Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo | Placebo | 1.6 | Standard Error 2.28 | points on a scale | |
| Change From Baseline in the TWSTRS-Total Score | incobotulinumtoxinA (Xeomin) (240 Units) | Baseline - Week 8 | -8.2 | Standard Deviation 10.54 | points on a scale |
| Change From Baseline in the TWSTRS-Total Score | incobotulinumtoxinA (Xeomin) (120 Units) | Baseline - Week 8 | -6.9 | Standard Deviation 11.15 | points on a scale |
| Change From Baseline in the TWSTRS-Total Score | Placebo | Baseline - Week 8 | 0.4 | Standard Deviation 7.17 | points on a scale |
| Change From Baseline in the TWSTRS-Total Score | incobotulinumtoxinA (Xeomin) (240 Units) | Baseline - Final Visit | -4.6 | Standard Deviation 7.52 | points on a scale |
| Change From Baseline in the TWSTRS-Total Score | incobotulinumtoxinA (Xeomin) (120 Units) | Baseline - Final Visit | -3.6 | Standard Deviation 8.07 | points on a scale |
| Change From Baseline in the TWSTRS-Total Score | Placebo | Baseline - Final Visit | 1.7 | Standard Deviation 6.15 | points on a scale |
| Change From Baseline in the TWSTRS Disability Subscore | incobotulinumtoxinA (Xeomin) (240 Units) | Baseline - Week 4 | -3.0 | Standard Deviation 4.35 | points on a scale |
| Change From Baseline in the TWSTRS Disability Subscore | incobotulinumtoxinA (Xeomin) (120 Units) | Baseline - Week 4 | -3.3 | Standard Deviation 4.72 | points on a scale |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Period - 8 to 20 Weeks | STARTED | incobotulinumtoxinA (Xeomin) (240 Units) | 81 | |
| Main Period - 8 to 20 Weeks | STARTED | incobotulinumtoxinA (Xeomin) (120 Units) | 78 | |
| Main Period - 8 to 20 Weeks | STARTED | Placebo | 74 | |
| Main Period - 8 to 20 Weeks | COMPLETED | incobotulinumtoxinA (Xeomin) (240 Units) | 76 | |
| Main Period - 8 to 20 Weeks | COMPLETED | incobotulinumtoxinA (Xeomin) (120 Units) | 75 | |
| Main Period - 8 to 20 Weeks | COMPLETED | Placebo | 68 | |
| Main Period - 8 to 20 Weeks | NOT COMPLETED | incobotulinumtoxinA (Xeomin) (240 Units) | 5 | |
| Main Period - 8 to 20 Weeks | NOT COMPLETED | incobotulinumtoxinA (Xeomin) (120 Units) | 3 | |
| Main Period - 8 to 20 Weeks | NOT COMPLETED | Placebo | 6 | |
| Extension Period - up to 68 Weeks | STARTED | incobotulinumtoxinA (Xeomin) (240 Units) | 111 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events30
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 | Dysphagia | Gastrointestinal disorders | incobotulinumtoxinA (Xeomin) (240 Units) | 15 | 81 | 17 |
| other | Dysphagia | Gastrointestinal disorders | incobotulinumtoxinA (Xeomin) (120 Units) | 9 | 78 | 10 |
| other | Dysphagia | Gastrointestinal disorders | Placebo | 2 | 74 | 2 |
| other | Injection site pain | General disorders | incobotulinumtoxinA (Xeomin) (240 Units) | 3 | 81 | 3 |
| other | Injection site pain | General disorders | incobotulinumtoxinA (Xeomin) (120 Units) | 7 | 78 | 7 |
| other | Injection site pain | General disorders | Placebo | 4 | 74 | 5 |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | incobotulinumtoxinA (Xeomin) (240 Units) | 9 | 81 | 12 |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | incobotulinumtoxinA (Xeomin) (120 Units) | 5 | 78 | 5 |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | Placebo | 1 | 74 | 1 |
| other | Musculosceletal pain | Musculoskeletal and connective tissue disorders | incobotulinumtoxinA (Xeomin) (240 Units) | 3 | 81 | 4 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | incobotulinumtoxinA (Xeomin) (240 Units) | ||
| Total, all-cause mortality | incobotulinumtoxinA (Xeomin) (120 Units) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | incobotulinumtoxinA (Xeomin) (240 Units) | 27 | 81 |
| Total, other adverse events | incobotulinumtoxinA (Xeomin) (120 Units) | 26 | 78 |
| Total, other adverse events | Placebo | 14 | 74 |
| Total, serious adverse events | incobotulinumtoxinA (Xeomin) (240 Units) | 4 | 81 |
| Total, serious adverse events | incobotulinumtoxinA (Xeomin) (120 Units) | 0 | 78 |
| Total, serious adverse events | Placebo | 0 | 74 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
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/NCT00407030
GET https://conductscience.org/api/trials/v1/NCT00407030/results?page=2