NCT06047457

A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study With Extension Phase to Evaluate the Efficacy and Safety of Dysport® for the Prevention of Episodic Migraine in Adult Participants

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 751 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing episodic migraine. A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head, and is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Episodic Migraine is defined as having less than 15 days of headache a month with at least 6 days with migraine headaches. Migraines are caused by a series of events which cause the brain to get stimulated / activated, which results in the release of chemicals that cause pain. Dysport® is a formulation of Botulinum toxin type A (BoNT-A), a medication that stops the release of these chemical messengers. The study will consist of 3 periods: 1. A 'screening period' of 6 to 12 weeks to assess whether the participant can take part to the study and requires 1 visit. 2. A first Treatment Phase of 24 weeks. On Day 1 and at Week 12 of the first Treatment Phase, participants will receive injections into various muscles across the head, neck, face and shoulders. The injections will contain either a dose "A" or a dose ''B'' of Dysport® or a placebo (an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied). Participants will make 4 visits to the clinic in person and have 4 remote (online) visits. 3. A second Treatment Phase of 24 weeks (extension phase). At Week 24 and at Week 36, all participants will get Dysport® (dose "A" or dose "B"). There will be 3 in person visits and 4 remote visits. Participants will need to complete an e-diary and questionnaires throughout the study. Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded. The total study duration for a participant will be up to 60 weeks (approx. 14 months).

Conditions

• Episodic Migraine

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin type A	Dose "A" U /Injection (U/I) , Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.
BIOLOGICAL	Botulinum toxin type A	Dose "B" U/I, IM on every 12 weeks during a period of 36 weeks with a total of 4 injections.
OTHER	Placebo	"0" U/I, IM on Day 1 and Week 12 with a total of 2 injections.
BIOLOGICAL	Botulinum toxin type A	Dose "A" U/I, IM on Week 24 and Week 36 with a total of 2 injections.
BIOLOGICAL	Botulinum toxin type A	Dose "B" U/I, IM on Week 24 and Week 36 with a total of 2 injections.

Timeline

• Start date: 2023-09-29
• Primary completion: 2026-05-27
• Completion: 2026-11-06
• First posted: 2023-09-21
• Last updated: 2026-04-06

Locations

105 sites across 8 countries: United States, Canada, Czechia, France, Georgia, Germany, Poland, Spain

Regulatory

• FDA-regulated drug study