Trial · NCT01261611
Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia
NCT01261611, Phase 3, Completed, Ipsen; results first posted 2019-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia. Trials, record NCT01261611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01261611
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia
- NCT number
- NCT01261611
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 382 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Cervical Dystonia
- Interventions
- Botulinum toxin type A, Botulinum toxin type A, Placebo
- First posted
- 2010-12-16
- Last updated
- 2022-09-28
- Other registries' IDs
- eudract:2010-019907-43
- Results first posted
- 2019-09-24
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle | Baseline and Week 4 | TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms. |
| Secondary | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Following First Treatment Cycle | Baseline and Week 4 | TWSTRS measures the degree of CD and comprises three different components, one of which is the Severity subscale. TWSTRS Severity subscale scores range from 0 (absence of severity) to 35 (maximum severity). If the change from baseline is negative, this represents an improvement in symptoms. |
| Secondary | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale Score Following First Treatment Cycle | Baseline and Week 4 | TWSTRS measures the degree of CD and comprises three different components, one of which is the Disability subscale. TWSTRS Disability subscale scores range from 0 (no disability) to 30 (maximum disability). If the change from baseline is negative, this represents an improvement in symptoms. |
| Secondary | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score Following First Treatment Cycle | Baseline and Week 4 | TWSTRS measures the degree of CD and comprises three different components, one of which is the Pain subscale. TWSTRS Pain subscale scores range from 0 (no pain) to 20 (maximum pain). If the change from baseline is negative, this represents an improvement in symptoms. |
| Secondary | Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia Following First Treatment Cycle | Baseline and Week 4 | The assessment was made on a continuous 100-mm horizontal line with a scale range of 0 mm (no pain) to 100 mm (worst possible pain). |
| Secondary | Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia Following First Treatment Cycle | Baseline and Week 4 | The assessment was made on a continuous 100-mm horizontal line with a scale range of 0 mm (no symptoms) to 100 mm (worst possible symptoms). |
| Secondary | Percentage of Treatment Responders Following First Treatment Cycle | Baseline and Week 4 | A treatment responder was defined as a patient with \>30% improvement in TWSTRS Total score compared to baseline. TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms. |
| Secondary | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score for Treatment Cycles 2 to 5 | Treatment cycle Baseline and Week 4 | TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms. |
| Secondary | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Score for Treatment Cycles 2 to 5 | Treatment cycle Baseline and Week 4 | TWSTRS measures the degree of CD and comprises three different components, one of which is the Severity subscale. TWSTRS Severity subscale scores range from 0 (absence of severity) to 35 (maximum severity). If the change from baseline is negative, this represents an improvement in symptoms. |
| Secondary | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Score for Treatment Cycles 2 to 5 | Treatment cycle Baseline and Week 4 | TWSTRS measures the degree of CD and comprises three different components, one of which is the Disability subscale. TWSTRS Disability subscale scores range from 0 (no disability) to 30 (maximum disability). If the change from baseline is negative, this represents an improvement in symptoms. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle | Baseline and Week 4 | Analysis based on number (n) of subjects in the Intent to Treat (ITT) population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Following First Treatment Cycle | Baseline and Week 4 | Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale Score Following First Treatment Cycle | Baseline and Week 4 | Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score Following First Treatment Cycle | Baseline and Week 4 | Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia Following First Treatment Cycle | Baseline and Week 4 | Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia Following First Treatment Cycle | Baseline and Week 4 | Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Treatment Responders Following First Treatment Cycle | Baseline and Week 4 | Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score for Treatment Cycles 2 to 5 | Treatment cycle Baseline and Week 4 | Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Score for Treatment Cycles 2 to 5 | Treatment cycle Baseline and Week 4 | Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Score for Treatment Cycles 2 to 5 | Treatment cycle Baseline and Week 4 | Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed. | Units on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group49
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 Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle | Dysport NG | -12.46 | 95% Confidence Interval -14.30 to -10.62 | Units on a scale | |
| Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle | Dysport | -13.99 | 95% Confidence Interval -15.78 to -12.21 | Units on a scale | |
| Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle | Placebo | -3.93 | 95% Confidence Interval -6.74 to -1.12 | Units on a scale | |
| Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Following First Treatment Cycle | Dysport NG | -6.2 | 95% Confidence Interval -7.0 to -5.4 | Units on a scale | |
| Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Following First Treatment Cycle | Dysport | -6.6 | 95% Confidence Interval -7.3 to -5.8 | Units on a scale | |
| Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Following First Treatment Cycle | Placebo | -1.9 | 95% Confidence Interval -3.1 to -0.6 | Units on a scale | |
| Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale Score Following First Treatment Cycle | Dysport NG | -3.3 | 95% Confidence Interval -4.1 to -2.6 | Units on a scale | |
| Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale Score Following First Treatment Cycle | Dysport | -3.9 | 95% Confidence Interval -4.7 to -3.2 | Units on a scale | |
| Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale Score Following First Treatment Cycle | Placebo | -0.8 | 95% Confidence Interval -1.9 to 0.4 | Units on a scale | |
| Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score Following First Treatment Cycle | Dysport NG | -3.10 | 95% Confidence Interval -3.70 to -2.51 | Units on a scale |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Cycle 1 | STARTED | Dysport NG | 156 | |
| Treatment Cycle 1 | STARTED | Dysport | 159 | |
| Treatment Cycle 1 | STARTED | Placebo | 54 | |
| Treatment Cycle 1 | COMPLETED | Dysport NG | 152 | |
| Treatment Cycle 1 | COMPLETED | Dysport | 156 | |
| Treatment Cycle 1 | COMPLETED | Placebo | 52 | |
| Treatment Cycle 1 | NOT COMPLETED | Dysport NG | 4 | |
| Treatment Cycle 1 | NOT COMPLETED | Dysport | 3 | |
| Treatment Cycle 1 | NOT COMPLETED | Placebo | 2 | |
| Treatment Cycle 2 | STARTED | Dysport NG | 359 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events174
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 | Dysport NG, 250U | 0 | 4 | 0 |
| other | Dysphagia | Gastrointestinal disorders | Dysport NG, 500U | 38 | 363 | 54 |
| other | Dysphagia | Gastrointestinal disorders | Dysport NG, 750U | 20 | 210 | 25 |
| other | Dysphagia | Gastrointestinal disorders | Dysport NG, 1000U | 5 | 57 | 5 |
| other | Dysphagia | Gastrointestinal disorders | Dysport, 500U | 11 | 156 | 11 |
| other | Dysphagia | Gastrointestinal disorders | Placebo | 0 | 55 | 0 |
| other | Nasopharyngitis | Infections and infestations | Dysport NG, 250U | 0 | 4 | 0 |
| other | Nasopharyngitis | Infections and infestations | Dysport NG, 500U | 21 | 363 | 26 |
| other | Nasopharyngitis | Infections and infestations | Dysport NG, 750U | 9 | 210 | 9 |
| other | Nasopharyngitis | Infections and infestations | Dysport NG, 1000U | 2 | 57 | 2 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dysport NG, 250U | ||
| Total, all-cause mortality | Dysport NG, 500U | ||
| Total, all-cause mortality | Dysport NG, 750U | ||
| Total, all-cause mortality | Dysport NG, 1000U | ||
| Total, all-cause mortality | Dysport, 500U | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dysport NG, 250U | 1 | 4 |
| Total, other adverse events | Dysport NG, 500U | 59 | 363 |
| Total, other adverse events | Dysport NG, 750U | 29 | 210 |
| Total, other adverse events | Dysport NG, 1000U | 7 | 57 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27653448 | DERIVED |
Source PubMed
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/NCT01261611
GET https://conductscience.org/api/trials/v1/NCT01261611/results?page=2