Trial · NCT01753336
Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia
NCT01753336, Phase 3, Completed, Ipsen; results first posted 2017-05-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia. Trials, record NCT01753336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01753336
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia
- NCT number
- NCT01753336
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 112 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Cervical Dystonia
- Interventions
- Botulinum toxin type A
- First posted
- 2012-12-20
- Last updated
- 2019-08-07
- Results first posted
- 2017-05-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) | Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. |
| Secondary | TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) | The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had received placebo. Mean TWSTRS total scores for pretreatment baseline and for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from pretreatment baseline scores at Week 4 and Week 12 of each treatment cycle are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. |
| Secondary | Treatment Response in Treatment Cycle 3 Week 4. | Week 4 Treatment Cycle 3 | Treatment response was defined as a reduction in the TWSTRS total score of at least 30% from pretreatment baseline to the Week 4 visit in Treatment Cycle 3. The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had previously received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had previously received placebo. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. The proportion (percentage) of subjects who were treatment responders at Week 4 of Treatment Cycle 3 are presented. |
| Secondary | TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) | Mean TWSTRS severity subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS severity subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for treatment cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The severity subscale gives a score from 0 to 35, with higher values indicating a worse outcome of physical findings of CD. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. |
| Secondary | TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) | Mean TWSTRS disability subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The disability subscale is a 6-item scale and each item is rated on a 6-point scale with higher values indicating the highest degree of disability. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. |
| Secondary | TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) | Mean TWSTRS pain subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The pain subscale gives a score from 0 to 20, with higher values indicating greater pain experienced. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. | units on a scale | MEAN |
| SECONDARY | TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. | units on a scale | MEAN |
| SECONDARY | Treatment Response in Treatment Cycle 3 Week 4. | Week 4 Treatment Cycle 3 | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. For Treatment Cycle 3 there were 91 evaluable subjects. | percentage of participants | NUMBER |
| SECONDARY | TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. | units on a scale | MEAN |
| SECONDARY | TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. | units on a scale | MEAN |
| SECONDARY | TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) | The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Total Dysport® | Mean TWSTRS score at Cycle 1-Day 1 | 37.7 | Standard Deviation 13.58 | units on a scale |
| TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Total Dysport® | Mean TWSTRS score at Cycle 1-Week 4 | 30.1 | Standard Deviation 13.16 | units on a scale |
| TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Total Dysport® | Mean TWSTRS score at Cycle 1-Week 12/Cycle 2-Day 1 | 32.6 | Standard Deviation 11.96 | units on a scale |
| TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Total Dysport® | Mean TWSTRS score at Cycle 2-Week 4 | 27.0 | Standard Deviation 12.07 | units on a scale |
| TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Total Dysport® | Mean TWSTRS score at Cycle 2-Week 12/Cycle 3-Day 1 | 31.1 | Standard Deviation 12.51 | units on a scale |
| TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Total Dysport® | Mean TWSTRS score at Cycle 3-Week 4 | 27.4 | Standard Deviation 13.10 | units on a scale |
| TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Total Dysport® | Mean TWSTRS score at Cycle 3-Week 12 | 30.1 | Standard Deviation 12.76 | units on a scale |
| TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Total Dysport® | Mean TWSTRS score at baseline for Study 169 | 42.2 | Standard Deviation 10.30 | units on a scale |
| TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Total Dysport® | Mean TWSTRS score at Cycle 1-Week 4 | 30.1 | Standard Deviation 13.16 | units on a scale |
| TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. | Total Dysport® | Mean TWSTRS score at Cycle 1-Week 12 | 32.6 | Standard Deviation 11.96 | units on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total Dysport® | 112 | |
| Overall Study | Cycle 1 | Total Dysport® | 112 | |
| Overall Study | Cycle 2 | Total Dysport® | 98 | |
| Overall Study | Cycle 3 | Total Dysport® | 93 | |
| Overall Study | COMPLETED | Total Dysport® | 92 | |
| Overall Study | NOT COMPLETED | Total Dysport® | 20 |
Source ClinicalTrials.gov
Adverse events129
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 | Muscular Weakness | Musculoskeletal and connective tissue disorders | Total Dysport® | 12 | 112 | 16 |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Total Dysport® | 12 | 112 | 13 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Total Dysport® | 3 | 112 | 3 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Total Dysport® | 2 | 112 | 2 |
| other | Muscle Spasms | Musculoskeletal and connective tissue disorders | Total Dysport® | 2 | 112 | 2 |
| other | Muscle Tightness | Musculoskeletal and connective tissue disorders | Total Dysport® | 2 | 112 | 2 |
| other | Muscle Weakness | Musculoskeletal and connective tissue disorders | Total Dysport® | 2 | 112 | 2 |
| other | Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | Total Dysport® | 2 | 112 | 2 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Total Dysport® | 2 | 112 | 2 |
| other | Bursitis | Musculoskeletal and connective tissue disorders | Total Dysport® | 1 | 112 | 1 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total Dysport® | ||
| Total, other adverse events | Total Dysport® | 70 | 112 |
| Total, serious adverse events | Total Dysport® | 7 | 112 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32884828 | 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.
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