Trials / Completed
CompletedNCT00258609
Dysport® In Migraine Without Aura Prophylaxis : DIMWAP Study
A 12-week Prospective, Double-blinded, Randomized, Multicenter Study of Low Dose and Medium Dose Botulinum Toxin Type A (Dysport® ) Injection for Migraine Prophylaxis.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 128 (planned)
- Sponsor
- Department of Medical Services Ministry of Public Health of Thailand · Other Government
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether 120 Unit, and 240 unit of botulinum toxin A are effective in the treatment of migraine without aura prophylaxis.
Detailed description
This is a 12-week, prospective double-blinded, randomized, multicenter study of placebo, 120 Unit, and 240 unit of botulinum toxin A ( Dysport ® ) injection for patient with a diagnosis of Migraine without aura according to International Headache Society criteria. It is designed to evaluate the efficacy, safety, tolerability and optimum dose of Botulinum toxin type A (Dysport ®)injection for migraine without aura prophylaxis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection |
Timeline
- Start date
- 2003-02-01
- Completion
- 2004-06-01
- First posted
- 2005-11-24
- Last updated
- 2019-02-18
Locations
6 sites across 1 country: Thailand
Source: ClinicalTrials.gov record NCT00258609. Inclusion in this directory is not an endorsement.