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NCT01753310 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
A Phase 3 study of Cervical Dystonia, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 134
- Enrollment target
- 20
- Study locations
NCT01753310: Completed Phase 3 study of Cervical Dystonia, sponsored by Ipsen.
NCT01753310 is a Phase 3 study of Cervical Dystonia that has completed, run by Ipsen. The registered enrollment target is 134 participants, above the 78-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (72% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01753310, a Phase 3 study of Cervical Dystonia, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 134 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.
Primary Outcome
The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. 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 sco
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Botulinum toxin type A
Study Locations (20)
Florida
- Parkinson's & Movement Disorders Center of Boca Raton - Boca Raton
- University of Florida Center for Movement Disorders and Neurorestoration - Gainesville
- Emerald Coast Center for Neurological Disorders - Pensacola
- PD Treatment Center of SW FL - Port Charlotte
- University of South Florida - Tampa
- Guilford Neurologic Associates - West Palm Beach
- Premiere Research Institute at Palm Beach Neurology - West Palm Beach
California
- East Bay Physician's Group - Berkeley
- Parkinson's and Movement Disorder Institute - Fountain Valley
- Loma Linda University Healthcare, Department of Neurology - Loma Linda
- USC Keck School of Medicine - Los Angeles
- UC Davis Medical Center - Sacramento
Arizona
- Movement Disorders Center of Arizona, LLC - Scottsdale
- University of Arizona - Tucson
Colorado
- University of Colorado at Denver Health Sciences - Aurora
- Advanced Neurosciences Research - Fort Collins
Alabama
- University of Alabama at Birmingham - Birmingham
Connecticut
- Associated Neurologists of Southern Connecticut - Fairfield
District of Columbia
- Georgetown University Hospital - Washington D.C.
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
What the finished NCT01753310 record still lists
NCT01753310 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, above the 78-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (72% higher).
The record links to 1 condition, with Cervical Dystonia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01753310 names 20 study sites across 8 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01753310 about?
NCT01753310 is a clinical study titled "Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.". The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.
What is the current status of trial NCT01753310?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 2013-01. Estimated completion is 2015-01.
What conditions does trial NCT01753310 study?
This clinical trial studies the following conditions: Cervical Dystonia.
What interventions are being tested in trial NCT01753310?
The interventions under investigation include: Placebo (DRUG), Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01753310?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01753310 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cervical Dystonia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01753310's enrollment target sits among peer trials
134 3rd of 15 higher than 13 of 15 other Cervical Dystonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Dystonia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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-
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