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NCT06047457 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults
A Phase 3 study of Episodic Migraine, sponsored by Ipsen.
- Active
- Registry status
- Phase 3
- Development phase
- 751
- Enrollment target
- 20
- Study locations
NCT06047457: Active Phase 3 study of Episodic Migraine, sponsored by Ipsen.
NCT06047457 is a Phase 3 study of Episodic Migraine that is active but no longer recruiting, run by Ipsen. The registered enrollment target is 751 participants, above the 439-participant average among 13 other Episodic Migraine trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06047457, a Phase 3 study of Episodic Migraine, is active but no longer recruiting, sponsored by Ipsen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 751 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 episodic 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. Episodic Migraine is defined as having less than 15 days of headache a month with at least 6 days with migraine headaches. 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 a 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 b
Primary Outcome
The monthly migraine days (MMD) is assessed by a daily eDiary, completed 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
- SDS Clinical Trials - Orange
- Alliance Clinical San Diego (Acclaim Clinical Research) - San Diego
- The Los Angeles Headache Center - Savannah
Florida
- Visionary Investigators Network (VIN) - Aventura
- Velocity Clinical Research - Hallandale Beach - Hallandale
- AGA Clinical Trials - Hialeah
- Infinity Clinical Research, LLC - Hollywood
- Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC) - Jacksonville
- 840042 - Miami
- Quantum Clinical Trials - Miami Beach
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 751 participants |
| Start Date | 2023-09-29 |
| Est. Completion | 2026-12-04 |
| Phase | Phase 3 |
What the registry record for NCT06047457 still lists
NCT06047457 is an interventional study that assigns participants to a tested intervention. The registered 751 participants enrollment target is mid-sized for trials with a published cap, above the 439-participant average among 13 other Episodic Migraine trials with a reported enrollment target (71% higher).
The record links to 1 condition, with Episodic Migraine appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06047457 names 20 study sites across 5 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06047457 about?
NCT06047457 is a clinical study titled "A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic 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 episodic 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 ...
What is the current status of trial NCT06047457?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 751 participants. The study started on 2023-09-29. Estimated completion is 2026-12-04.
What conditions does trial NCT06047457 study?
This clinical trial studies the following conditions: Episodic Migraine.
What interventions are being tested in trial NCT06047457?
The interventions under investigation include: Placebo (OTHER), Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT06047457?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06047457 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06047457's enrollment target sits among peer trials
751 2nd of 13 the highest of 13 other Episodic Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Episodic 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.
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