Trials / Completed
CompletedNCT01753336
Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia
A Phase IIIb, Prospective, Multicentre, Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport® Using 2 mL Dilution In Adults With Cervical Dystonia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum toxin type A | Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2015-10-01
- Completion
- 2015-10-01
- First posted
- 2012-12-20
- Last updated
- 2019-08-07
- Results posted
- 2017-05-04
Locations
41 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01753336. Inclusion in this directory is not an endorsement.