Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

A Phase II, Multicentre, Randomised, Double-blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis

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.

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