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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Chronic Migraine

In brief

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).

Key facts

Study ID

NCT06047444

Run by

Ipsen

People needed

759

Starts

2023-10-12

Expected to finish

2026-11-06

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be ≥18 years of age inclusive, at the time of signing the informed consent and privacy/data protection documentation
• Participant has a diagnosis for more than 12 months, prior to screening visit, of chronic migraine according to the International Classification of Headache Disorders definition and diagnostic criteria
• Migraine onset occurred when participant was <50 years of age
• Has baseline number of monthly headache days (MHD) ≥15 and baseline number of monthly migraine days (MMD) of ≥8, using eDiary data collected during the 4 weeks nearest to randomisation on Day 1 (but prior to randomisation)
• Has baseline number of valid diary days ≥22 days collected during the 4 weeks nearest to randomisation on Day 1
• Participant must have previously used, or is currently using, preventive treatment for migraine (pharmacological) (i.e. non-naïve) prior to start of screening eDiary

You may not qualify if…

• History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache
• Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache, which is permitted
• Use of any of the following medications in the specified timeframe prior to start of the screening daily headache eDiary:
• Within 24 weeks
• i. Botulinum toxin for migraine (or for any other medical/aesthetic reason within 16 weeks)
• Within 12 weeks
• i. CGRP antagonists (monoclonal antibody or gepant) for preventive treatment of migraine (acute treatment of headache/migraine with a gepant is permitted but limited to no more than 6 days per month (i.e 6 days per each 4-week period with gepant intake))
• ii. Cannabidiol or other types of cannabinoids
• Within 4 weeks
• i. Anaesthetic or steroid injection in any region targeted for injection with study intervention
• ii. Use of medical device to treat migraine (e.g. non-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation, and peripheral neuroelectrical stimulation)
• iii. Other interventions for migraine assessed to interfere with study evaluations (e.g. acupuncture in head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments, and dental splints for headache)
• iv. Use of opioids or barbiturates for more than 2 days/month. Note: participants are permitted to take one concomitant migraine preventative treatment (not listed above); however, the dose of this medication should be stable for ≥3 months before start of the screening eDiary
• Known history of treatment failure to more than four medications prescribed for the prevention of migraine (two of which have different mechanisms of action) or known history of treatment failure to botulinum toxin prescribed for the prevention of migraine.

Where it is running

• CCT Research — Phoenix, Arizona, United States
• HonorHealth Neurology — Scottsdale, Arizona, United States
• Hope Clinical Research, LLC — Canoga Park, California, United States
• Axiom Research LLC — Colton, California, United States
• Fullerton Neurological Center — Fullerton, California, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• The Los Angeles Headache Center — Los Angeles, California, United States
• SDS Clinical Trials — Orange, California, United States
• 840011 — Palo Alto, California, United States
• Stanford University School of Medicine - Stanford Cardiovascular Institute (CVI) — Palo Alto, California, United States
• Alliance Clinical San Diego (Acclaim Clinical Research) — San Diego, California, United States
• University of Colorado Hospital - Neurology Clinic — Aurora, Colorado, United States
• Yale University School of Medicine — East Hartford, Connecticut, United States
• Hasbani Neurology — New Haven, Connecticut, United States
• New England Institute for Neurology and Headache (NEINH)/Medical Practice — Stamford, Connecticut, United States
• Visionary Investigators Network (VIN) — Aventura, Florida, United States
• Velocity Clinical Research - Hallandale Beach — Hallandale, Florida, United States
• AGA Clinical Trials — Hialeah, Florida, United States
• Infinity Clinical Research, LLC — Hollywood, Florida, United States
• Neurology Clinical Research, Inc. — Hollywood, Florida, United States
• Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC) — Jacksonville, Florida, United States
• University of Miami Leonard M. Miller School of Medicine - Professional Arts Center — Miami, Florida, United States
• Quantum Clinical Trials — Miami Beach, Florida, United States
• Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry) — Orlando, Florida, United States
• Central Research Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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