Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

Ipsen

Status and phase

Completed

Phase 2

Conditions

Migraine

Treatments

Biological: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00301665

A-38-52120-715

Details and patient eligibility

About

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.

Enrollment

138 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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