🏛️ Verified NIH Record • Updated 2026-07-15

A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults (NCT06047444)

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 Chronic Migraine in Adult Participants

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Ipsen

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (12 items).

Location: Central Research Associates — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria :
  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (120 Sites)

Showing the first 25 of 120 sites.

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

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
  • 💵 Compensation indicated: 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.

More studies in Chronic Migraine

Explore by condition: All Chronic Migraine clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗