A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults
Public ClinicalTrials.gov record NCT06047444. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06047444
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 759 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 11, 2023
- Primary completion
- May 27, 2026
- Completion
- Nov 11, 2026
- Last update posted
- Sep 3, 2026
2023 – 2026
United States locations
- U.S. sites
- 72
- U.S. states
- 27
- U.S. cities
- 64
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Research Associates | Birmingham | Alabama | 35205 | — |
| CCT Research | Phoenix | Arizona | 85044 | — |
| HonorHealth Neurology | Scottsdale | Arizona | 85251 | — |
| Hope Clinical Research, LLC | Canoga Park | California | 91303 | — |
| Axiom Research LLC | Colton | California | 92324 | — |
| Fullerton Neurological Center | Fullerton | California | 92835 | — |
| Neurology Center of North Orange County | Fullerton | California | 92835 | — |
| The Los Angeles Headache Center | Los Angeles | California | 90067 | — |
| SDS Clinical Trials | Orange | California | 92868 | — |
| 840011 | Palo Alto | California | 94304 | — |
| Stanford University School of Medicine - Stanford Cardiovascular Institute (CVI) | Palo Alto | California | 94304 | — |
| Alliance Clinical San Diego (Acclaim Clinical Research) | San Diego | California | 92120 | — |
| University of Colorado Hospital - Neurology Clinic | Aurora | Colorado | 80045 | — |
| Yale University School of Medicine | East Hartford | Connecticut | 06118 | — |
| Hasbani Neurology | New Haven | Connecticut | 06511 | — |
| New England Institute for Neurology and Headache (NEINH)/Medical Practice | Stamford | Connecticut | 06905 | — |
| Visionary Investigators Network (VIN) | Aventura | Florida | 33180 | — |
| Velocity Clinical Research - Hallandale Beach | Hallandale | Florida | 33009 | — |
| AGA Clinical Trials | Hialeah | Florida | 33012 | — |
| Infinity Clinical Research, LLC | Hollywood | Florida | 33024 | — |
| Neurology Clinical Research, Inc. | Hollywood | Florida | 33024 | — |
| Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC) | Jacksonville | Florida | 32256 | — |
| University of Miami Leonard M. Miller School of Medicine - Professional Arts Center | Miami | Florida | 33136 | — |
| Quantum Clinical Trials | Miami Beach | Florida | 33140 | — |
| Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry) | Orlando | Florida | 32801 | — |
| Guardian Angel Research Center | Tampa | Florida | 33614 | — |
| USF Health-Morsani Center | Tampa | Florida | 33620 | — |
| Conquest Research | Winter Park | Florida | 32789 | — |
| Headache Wellness Center | Greensboro | Georgia | 27405 | — |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | — |
| Chicago Headache Center & Research | Chicago | Illinois | 60657 | — |
| Robbins Headache Clinic | Riverwoods | Illinois | 60015 | — |
| MD Fort Wayne Neurological Center | Fort Wayne | Indiana | 46804 | — |
| Comprehensive Neurology Services | Frederick | Maryland | 21702 | — |
| Boston Clinical Trials Inc | Boston | Massachusetts | 02131 | — |
| Beth Israel Deaconess Medical Center - Arnold Pain Management | Brookline | Massachusetts | 02115 | — |
| Neurology Center of NE,PC - Neurology | Foxborough | Massachusetts | 02035 | — |
| Mass Institute of Clinical Research | Westborough | Massachusetts | 01581 | — |
| New England Regional Headache Center, Inc. | Worcester | Massachusetts | 01609 | — |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | — |
| Minneapolis Clinic of Neurology | Burnsville | Minnesota | 55337 | — |
| Papillion Research Center | Papillion | Nebraska | 68046 | — |
| WR-CRCN | Las Vegas | Nevada | 89106 | — |
| Alliance Clinical Las Vegas (Excel Clinical Research) | Las Vegas | Nevada | 89109 | — |
| Dent Neurosciences Research Center, Inc. | Amherst | New York | 14226 | — |
| SPRI Clinical Trials, LLC | Brooklyn | New York | 11235 | — |
| Nuvance Health Medical Practice | Poughkeepsie | New York | 12601 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Blue Sky MD | Hendersonville | North Carolina | 28792 | — |
| Headache Center of Hope | Cincinnati | Ohio | 45236 | — |
| OrthoNeuro | New Albany | Ohio | 43054 | — |
| Helios Clinical Research | Wooster | Ohio | 44691 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology | Philadelphia | Pennsylvania | 19107 | — |
| Coastal Carolina Research Center - North Charleston | North Charleston | South Carolina | 29405 | — |
| Neurology Clinic, PC | Cordova | Tennessee | 38018 | — |
| KCA Neurology, PLLC | Franklin | Tennessee | 37067 | — |
| Helios Clinical Research LLC (Helios CR, Inc. Jackson TN) | Jackson | Tennessee | 38305 | — |
| Herzog, Steven MD | Dallas | Texas | 75214 | — |
| Texas Neurology | Dallas | Texas | 75214 | — |
| Zenos Clinical Research | Dallas | Texas | 75230 | — |
| Lone Star Neurology | Frisco | Texas | 75035 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| Research Your Health | Plano | Texas | 75093 | — |
| J. Lewis Research Inc.-Foothill | Salt Lake City | Utah | 84109 | — |
| Metrodora Institute | West Valley City | Utah | 84119 | — |
| Inova Medical Group - Neurology | Fairfax | Virginia | 22031 | — |
| MedStar Health - Department of Neurology | Columbia | Washington | 20010 | — |
| Frontier Clinical Research, LLC | Kingwood | West Virginia | 26537 | — |
| BCN Research, LLC | Greenfield | Wisconsin | 53228 | — |
| Neuroscience Group of Northeast Wisconsin-Neenah | Neenah | Wisconsin | 54956 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06047444, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2026 · Synced Sep 7, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06047444 live on ClinicalTrials.gov.