Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 120
• Participant gender: Both

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA
• Last Updated: 2007-09-12

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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