Trials / Completed
CompletedNCT01249404
Dysport® Adult Lower Limb Spasticity Study
A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 388 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum toxin type A | I.M. injection on day 1 (single treatment cycle) |
| DRUG | Placebo | I.M. injection on day 1 (single treatment cycle) |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2013-12-01
- Completion
- 2014-05-01
- First posted
- 2010-11-29
- Last updated
- 2022-09-28
- Results posted
- 2017-10-17
Locations
62 sites across 11 countries: United States, Australia, Belgium, Czechia, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia
Source: ClinicalTrials.gov record NCT01249404. Inclusion in this directory is not an endorsement.