Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

Phase 2

Completed

• Conditions: Migraine

• Registration Number: NCT00301665
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study Completion: 2005-03
• Study First Submitted: 2006-03-09
• Study First Submitted QC: 2006-03-09
• Study First Posted: 2006-03-13
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Significant decrease of the number of migraine attacks with Dysport® compared to placebo.	3 months

Secondary Outcome Measures

Name	Time	Method
Reduction of migraine medication consumption.	3 months
Improvement of quality of life.	3 months
Reduction of the intensity of the migraine attacks.	3 months
Reduction of duration of the migraine attacks.	3 months

Trial Locations

Locations (9)

Faculty Hospital; 🇸🇰 Martin, Slovakia

Voivodeship (Provincial) Specialist Hospital; 🇵🇱 Zgierz, Poland

St. Anne's Faculty Hospital; 🇨🇿 Brno, Czechia

General Faculty Hospital; 🇨🇿 Prague 2, Czechia

Faculty Hospital Bratislava; 🇸🇰 Bratislava, Slovakia

Medical Academy of Poznan; 🇵🇱 Poznan, Poland

Air Force Institute of Aviation Medicine; 🇵🇱 Warsaw, Poland

City Hospital of Wolomin; 🇵🇱 Wolomin, Poland

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia