Migraine
Conditions
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.
Interventions
BIOLOGICALBotulinum toxin type A
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant decrease of the number of migraine attacks with Dysport® compared to placebo. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of the intensity of the migraine attacks. | 3 months |
| Reduction of duration of the migraine attacks. | 3 months |
| Reduction of migraine medication consumption. | 3 months |
| Improvement of quality of life. | 3 months |
Countries
Czechia, Poland, Slovakia
Outcome results
None listed