Trials / Completed
CompletedNCT01915459
Phase III Study of Botulax® to Treat Post Stroke Upper Limb Spasticity
A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Treatment of Post Stroke Upper Limb Spasticity
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 186 (actual)
- Sponsor
- Hugel · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of Botulax® compared to Botox® reducing upper limb muscle tone in post stroke patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum toxin type A(Botulax®) | IM, total dose of 360 Units at wrist flexor, elbow flexor, finger flexor, and thumb flexor based on muscle tone |
| BIOLOGICAL | Botulinum toxin type A(Botox®) |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2014-05-01
- Completion
- 2014-07-01
- First posted
- 2013-08-05
- Last updated
- 2015-05-04
Locations
6 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01915459. Inclusion in this directory is not an endorsement.