Trials / Completed
CompletedNCT03905304
Efficacy and Safety of MEDITOXIN® in Cervical Dystonia
A Prospective, Randomized, Multi-center, Phase III, Double-Blind, Activi Controlled, Parallel-group Study to Evaliate the Efficacy and Safety of MEDITOXIN® Comparison With BOTOX® in Treatment of Cervical Dystonia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 152 (actual)
- Sponsor
- Medy-Tox · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.
Detailed description
The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 200\~300U in cervical muscles. The efficacy and safety are evaluated for 12weeks through 4 follow up visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Medytoxin | Intramuscular injection up to 300U. |
| BIOLOGICAL | Botox | Intramuscular injection up to 300U. |
Timeline
- Start date
- 2013-01-09
- Primary completion
- 2014-07-30
- Completion
- 2014-08-05
- First posted
- 2019-04-05
- Last updated
- 2019-04-08
Source: ClinicalTrials.gov record NCT03905304. Inclusion in this directory is not an endorsement.