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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06047444
The ClinicalTrials.gov registry entry for NCT06047444 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 759 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 299-participant average among 17 other Chronic Migraine trials with a reported enrollment target (154% higher). The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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