Trials / Completed
CompletedNCT01313299
Dysport® Adult Upper Limb Spasticity
A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 243 (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 upper limb spasticity due to stroke or traumatic brain injury.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum toxin type A | 500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle. |
| BIOLOGICAL | Botulinum toxin type A | 1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle. |
| DRUG | Placebo | I.M. (in the muscle) injection on day 1 of a single treatment cycle. |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2013-09-01
- Completion
- 2013-09-01
- First posted
- 2011-03-11
- Last updated
- 2022-09-28
- Results posted
- 2015-10-23
Locations
40 sites across 9 countries: United States, Belgium, Czechia, France, Hungary, Italy, Poland, Russia, Slovakia
Source: ClinicalTrials.gov record NCT01313299. Inclusion in this directory is not an endorsement.