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MinorCompletion date: Nov 6, 2026 to Nov 12, 2026v38
MinorPrimary completion date changed from estimate of May 21, 2026 to May 28, 2026v37
MinorPrimary completion date: May 27, 2026 to May 21, 2026v36
MinorPrimary completion date: Jun 5, 2026 to May 27, 2026Completion date: Dec 4, 2026 to Nov 6, 2026v35Show 1 more changeShow less
Completion date: Dec 4, 2026 to Nov 6, 2026
MinorRe-verified, no change to tracked fieldsv34
Show 32 earlier versionsHide 32 earlier versions
NotablePrimary endpoint revisedEnrollment target: estimated 720 to confirmed 759 · Study sites: 119 to 120 · Primary completion date: Jun 22, 2026 to Jun 5, 2026 · 2 morev33Show 5 more changesShow less
Enrollment target: estimated 720 to confirmed 759
Study sites: 119 to 120
Primary completion date: Jun 22, 2026 to Jun 5, 2026
Minor4 versionsRe-verified since Apr 26, 2024, no change to tracked fieldsv13-v16
NotablePrimary completion date: Jul 31, 2025 to Jun 22, 2026Study sites: 44 to 89 · Completion date: Dec 31, 2025 to Dec 21, 2026v12Show 2 more changesShow less
Study sites: 44 to 89
Completion date: Dec 31, 2025 to Dec 21, 2026
MinorStudy sites: 55 to 44v11
MinorStudy sites: 31 to 55v10
Minor2 versionsRe-verified since Jan 30, 2024, no change to tracked fieldsv8-v9
MinorCompletion date: Jul 31, 2025 to Dec 31, 2025Interventions: Dysport® (Biological), Dysport® (Biological), Dysport® (Biological), Dysport® (Biological), Placebo (Other) to Botulinum toxin type A (Biological), Botulinum toxin type A (Biological), Botulinum toxin type A (Biological), Botulinum toxin type A… · Site details revised at 2 of 31 sitesv7Show 2 more changesShow less
Interventions: Dysport® (Biological), Dysport® (Biological), Dysport® (Biological), Dysport® (Biological), Placebo (Other) to Botulinum toxin type A (Biological), Botulinum toxin type A (Biological), Botulinum toxin type A (Biological), Botulinum toxin type A…
Site details revised at 2 of 31 sites
MinorStudy sites: 7 to 31Primary and study completion dates: Jan 26, 2026 to Jul 31, 2025v6Show 1 more changeShow less
Primary and study completion dates: Jan 26, 2026 to Jul 31, 2025
NotablePrimary completion date: Jun 1, 2025 to Jan 26, 2026v5
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of Oct 2023 to Oct 12, 2023 · Site details revised at 7 of 7 sitesv4Show 2 more changesShow less
Start date changed from estimate of Oct 2023 to Oct 12, 2023
Site details revised at 7 of 7 sites
MinorStudy sites: 0 to 7Start date: Sep 2023 to Oct 2023v3Show 1 more changeShow less
Start date: Sep 2023 to Oct 2023
MinorSecondary endpoints revised (27)Eligibility criteria expanded, about 3 wordsv2Show 1 more changeShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing chronic 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.
Chronic migraine is defined as having at least 15 days of headache a month with at least 8 of those days being migraine headache days.
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 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).