Botulinum toxin type A: Dose "A" U /Injection (U/I) , Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.
Botulinum toxin type A: Dose "B" U/I, IM on every 12 weeks during a period of 36 weeks with a total of 4 injections.
Placebo: "0" U/I, IM on Day 1 and Week 12 with a total of 2 injections.
Botulinum toxin type A: Dose "A" U/I, IM on Week 24 and Week 36 with a total of 2 injections.
Botulinum toxin type A: Dose "B" U/I, IM on Week 24 and Week 36 with a total of 2 injections.
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 be up to 60 weeks (approx. 14 months).
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| SDS Clinical Trials | Orange | California | |
| Alliance Clinical San Diego (Acclaim Clinical Research) | San Diego | California | |
| The Los Angeles Headache Center | Savannah | California | |
| 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 | |
| Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC) | Jacksonville | Florida | |
| 840042 | Miami | Florida | |
| Quantum Clinical Trials | Miami Beach | Florida | |
| Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry) | Orlando | Florida | |
| Guardian Angel Research Center | Tampa | Florida | |
| Boston Clinical Trials Inc | Winter Park | Florida | |
| Conquest Research | Winter Park | Florida | |
| Cedar Crosse Research Center | Chicago | Illinois | |
| Chicago Headache Center & Research Institute | Chicago | Illinois | |
| Robbins Headache Clinic | Riverwoods | Illinois | |
| MD Fort Wayne Neurological Center | Fort Wayne | Indiana | |
| Comprehensive Neurology Services | Frederick | Maryland | |
| Boston Clinical Trials Inc | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center - Arnold Pain Management | Brookline | Massachusetts | |
| Neurology Center of NE,PC - Neurology | Foxborough | Massachusetts | |
| Lone Star Neurology, | Westborough | Massachusetts | |
| New England Regional Headache Center, Inc. | Worcester | Massachusetts | |
| Quest Research Institute | Farmington Hills | Michigan | |
| Minneapolis Clinic of Neurology | Burnsville | Minnesota | |
| Clinical Research Professionals | Chesterfield | Missouri | |
| M3 Wake Research - Las Vegas Wellness Way | Las Vegas | Nevada | |
| Alliance Clinical Las Vegas (Excel Clinical Research) | Las Vegas | Nevada | |
| SPRI Clinical Trials, LLC | Brooklyn | New York |
+ 65 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06047457 on ClinicalTrials.gov ↗ ← All trials in the USA