Trials / Completed
CompletedNCT01753310
Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum toxin type A | Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only |
| DRUG | Placebo | Up to 2mL |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2014-10-01
- Completion
- 2015-01-01
- First posted
- 2012-12-20
- Last updated
- 2019-08-07
- Results posted
- 2017-03-16
Locations
42 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01753310. Inclusion in this directory is not an endorsement.