Status:
COMPLETED
Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis
Lead Sponsor:
Ipsen
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®) injections into pericranial muscles compared to placebo to prevent migraine attacks.
Eligibility Criteria
Inclusion
- Patients having migraine without aura or with typical aura as defined by International Headache Society criteria
- Migraine attacks have been persisting for more than 1 year
- 2 to 6 migraine attacks per month of at least moderate severity over the 3 months preceding the pre-inclusion visit
- 2 to 6 migraine attacks of at least moderate severity during the screening period
Exclusion
- Non-migraine headaches such as tension-type headaches
- Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migraine aura without headache, migraine with acute onset aura, ophthalmoplegic migraine, retinal migraine, complications of migraine
- Onset of migraine is after age of 50
- Overuse of acute migraine medications (individuals who take medications for acute migraine more than 10 days per month) or have a history of drug or alcohol abuse
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00301665
Start Date
February 1 2003
End Date
March 1 2005
Last Update
April 24 2020
Active Locations (9)
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1
St. Anne's Faculty Hospital
Brno, Czechia, 65691
2
University Hospital Hradec Kralove
Hradec Králové, Czechia, 50005
3
General Faculty Hospital
Prague, Czechia, 120 00
4
Medical Academy of Poznan
Poznan, Poland, 60-355