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NCT06047444 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults
A Phase 3 study of Chronic Migraine, sponsored by Ipsen.
- Active
- Registry status
- Phase 3
- Development phase
- 759
- Enrollment target
- 20
- Study locations
NCT06047444: Active Phase 3 study of Chronic Migraine, sponsored by Ipsen.
NCT06047444 is a Phase 3 study of Chronic Migraine that is active but no longer recruiting, run by Ipsen. The registered enrollment target is 759 participants, above the 299-participant average among 17 other Chronic Migraine trials with a reported enrollment target (154% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06047444, a Phase 3 study of Chronic Migraine, is active but no longer recruiting, sponsored by Ipsen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 759 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Primary Outcome
The monthly migraine days (MMD) is assessed by eDiary, completed every day by the participant, to evaluate the efficacy of Dysport® compared to placebo.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Botulinum toxin type A
Study Locations (20)
California
- Hope Clinical Research, LLC - Canoga Park
- Axiom Research LLC - Colton
- Fullerton Neurological Center - Fullerton
- Neurology Center of North Orange County - Fullerton
- The Los Angeles Headache Center - Los Angeles
- SDS Clinical Trials - Orange
- 840011 - Palo Alto
- Stanford University School of Medicine - Stanford Cardiovascular Institute (CVI) - Palo Alto
- Alliance Clinical San Diego (Acclaim Clinical Research) - San Diego
Florida
- Visionary Investigators Network (VIN) - Aventura
- Velocity Clinical Research - Hallandale Beach - Hallandale
- AGA Clinical Trials - Hialeah
- Infinity Clinical Research, LLC - Hollywood
Connecticut
- Yale University School of Medicine - East Hartford
- Hasbani Neurology - New Haven
- New England Institute for Neurology and Headache (NEINH)/Medical Practice - Stamford
Arizona
- CCT Research - Phoenix
- HonorHealth Neurology - Scottsdale
Alabama
- Central Research Associates - Birmingham
Colorado
- University of Colorado Hospital - Neurology Clinic - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 759 participants |
| Start Date | 2023-10-12 |
| Est. Completion | 2026-12-04 |
| Phase | Phase 3 |
What the registry record for NCT06047444 still lists
NCT06047444 is an interventional study that assigns participants to a tested intervention. The registered 759 participants enrollment target is mid-sized for trials with a published cap, above the 299-participant average among 17 other Chronic Migraine trials with a reported enrollment target (154% higher).
The record links to 1 condition, with Chronic Migraine appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06047444 names 20 study sites across 6 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06047444 about?
NCT06047444 is a clinical study titled "A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults". 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 f...
What is the current status of trial NCT06047444?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 759 participants. The study started on 2023-10-12. Estimated completion is 2026-12-04.
What conditions does trial NCT06047444 study?
This clinical trial studies the following conditions: Chronic Migraine.
What interventions are being tested in trial NCT06047444?
The interventions under investigation include: Placebo (OTHER), Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT06047444?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06047444 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06047444's enrollment target sits among peer trials
759 3rd of 17 higher than 15 of 17 other Chronic Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
BOTOX® vs. XEOMIN® for Chronic Migraine
RECRUITING · Phase 3
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A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
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A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
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A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
ACTIVE NOT RECRUITING · Phase 3
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Responding With Evidence and Access for Childhood Headaches
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-
Determining the Utility of a Behavioral Intervention in Chronic Migraine
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