Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults
Sponsor: Ipsen
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 up to 60 weeks (approx. 14 months).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
759
Start Date
2023-10-12
Completion Date
2026-11-06
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Botulinum toxin type A
Dose "A" Unit/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 at Week 24 and Week 36 with a total of 2 injections.
Botulinum toxin type A
Dose "B" U/I, IM at Week 24 and Week 36 with a total of 2 injections.
Locations (120)
Central Research Associates
Birmingham, Alabama, United States
CCT Research
Phoenix, Arizona, United States
HonorHealth Neurology
Scottsdale, Arizona, United States
Hope Clinical Research, LLC
Canoga Park, California, United States
Axiom Research LLC
Colton, California, United States
Fullerton Neurological Center
Fullerton, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
The Los Angeles Headache Center
Los Angeles, California, United States
SDS Clinical Trials
Orange, California, United States
840011
Palo Alto, California, United States
Stanford University School of Medicine - Stanford Cardiovascular Institute (CVI)
Palo Alto, California, United States
Alliance Clinical San Diego (Acclaim Clinical Research)
San Diego, California, United States
University of Colorado Hospital - Neurology Clinic
Aurora, Colorado, United States
Yale University School of Medicine
East Hartford, Connecticut, United States
Hasbani Neurology
New Haven, Connecticut, United States
New England Institute for Neurology and Headache (NEINH)/Medical Practice
Stamford, Connecticut, United States
Visionary Investigators Network (VIN)
Aventura, Florida, United States
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
Infinity Clinical Research, LLC
Hollywood, Florida, United States
Neurology Clinical Research, Inc.
Hollywood, Florida, United States
Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC)
Jacksonville, Florida, United States
University of Miami Leonard M. Miller School of Medicine - Professional Arts Center
Miami, Florida, United States
Quantum Clinical Trials
Miami Beach, Florida, United States
Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry)
Orlando, Florida, United States
Guardian Angel Research Center
Tampa, Florida, United States
USF Health-Morsani Center
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
Headache Wellness Center
Greensboro, Georgia, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Chicago Headache Center & Research
Chicago, Illinois, United States
Robbins Headache Clinic
Riverwoods, Illinois, United States
MD Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Comprehensive Neurology Services
Frederick, Maryland, United States
Boston Clinical Trials Inc
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center - Arnold Pain Management
Brookline, Massachusetts, United States
Neurology Center of NE,PC - Neurology
Foxborough, Massachusetts, United States
Mass Institute of Clinical Research
Westborough, Massachusetts, United States
New England Regional Headache Center, Inc.
Worcester, Massachusetts, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Minneapolis Clinic of Neurology
Burnsville, Minnesota, United States
Papillion Research Center
Papillion, Nebraska, United States
WR-CRCN
Las Vegas, Nevada, United States
Alliance Clinical Las Vegas (Excel Clinical Research)
Las Vegas, Nevada, United States
Dent Neurosciences Research Center, Inc.
Amherst, New York, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Nuvance Health Medical Practice
Poughkeepsie, New York, United States
Rochester Clinical Research
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Blue Sky MD
Hendersonville, North Carolina, United States
Headache Center of Hope
Cincinnati, Ohio, United States
OrthoNeuro
New Albany, Ohio, United States
Helios Clinical Research
Wooster, Ohio, United States
Suburban Research Associates
Media, Pennsylvania, United States
Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology
Philadelphia, Pennsylvania, United States
Coastal Carolina Research Center - North Charleston
North Charleston, South Carolina, United States
Neurology Clinic, PC
Cordova, Tennessee, United States
KCA Neurology, PLLC
Franklin, Tennessee, United States
Helios Clinical Research LLC (Helios CR, Inc. Jackson TN)
Jackson, Tennessee, United States
Herzog, Steven MD
Dallas, Texas, United States
Texas Neurology
Dallas, Texas, United States
Zenos Clinical Research
Dallas, Texas, United States
Lone Star Neurology
Frisco, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Research Your Health
Plano, Texas, United States
J. Lewis Research Inc.-Foothill
Salt Lake City, Utah, United States
Metrodora Institute
West Valley City, Utah, United States
Inova Medical Group - Neurology
Fairfax, Virginia, United States
MedStar Health - Department of Neurology
Columbia, Washington, United States
Frontier Clinical Research, LLC
Kingwood, West Virginia, United States
BCN Research, LLC
Greenfield, Wisconsin, United States
Neuroscience Group of Northeast Wisconsin-Neenah
Neenah, Wisconsin, United States
Centricity Research Halifax Multispecialty
Halifax, Canada
Genge Partners Inc.
Montreal, Canada
CARe Clinic-Calgary
Red Deer, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Canada
Royal Julilee Hospital
Victoria, Canada
Neurologie Brno s.r.o.
Brno, Czechia
Pratia Brno s.r.o.
Brno, Czechia
NeuropsychiatrieHK, s.r.o.
Hradec Králové, Czechia
Nemocnice Jihlava, p.o.
Jihlava, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, Czechia
Axon Clinical, s.r.o.
Prague, Czechia
DADO MEDICAL s.r.o.
Prague, Czechia
Fakultni Thomayerova nemocnice
Prague, Czechia
Institut neuropsychiatricke pece
Prague, Czechia
Ltd "Health"
Batumi, Georgia
ISR-GEO Med Res Clin Healthycore
Tbilisi, Georgia
"Pineo Medical Ecosystem" LTD
Tbilisi, Georgia
LTD New Hospitals
Tbilisi, Georgia
LTD S.Khechinashvili University Hospital
Tbilisi, Georgia
Multprofil Clinic Consilium Medulla
Tbilisi, Georgia
Charité - Universitätsmedizin Berlin KöR
Berlin, Germany
Emovis GmbH
Berlin, Germany
Universitätsmedizin Greifswald
Greifswald, Germany
Curiositas ad sanum Studien- und Beratungs GmbH Haag i.OB
Haag in Oberbayern, Germany
Vitos Orthopaedische Klinik Kassel
Kassel, Germany
LMU - Klinikum der Universität München - Campus Grosshadern
München, Germany
Ospedale Bellaria, IRCCS Istituto delle Scienze Neurologiche, AUSL di Bologna
Bologna, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Naples, Italy
IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia, Italy
Istituto Neurologico Mediterraneo - NEUROMED, Istituto di Ricovero e Cura a Carattere Scientifico
Pozzilli, Italy
IRCCS San Raffaele Pisana
Roma, Italy
PU Campus Bio-Medico di Roma
Roma, Italy
Centrum Medyczne Neuromed Pawel Lisewski
Bydgoszcz, Poland
Synexus Polska Sp. z o.o.
Gdynia, Poland
Centrum Medyczne Pratia Katowice
Katowice, Poland
Krakowska Akademia Neurologii Sp. z o.o.
Krakow, Poland
Krakowskie Centrum MedyczneSp.z o.o
Krakow, Poland
Pratia MCM Krakow
Krakow, Poland
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej
Lublin, Poland
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Oświęcim, Poland
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario Regional De Malaga
Málaga, Spain
Hospital Universitario Virgen De La Macarena
Seville, Spain
Hospital Clinico Universitario De Valencia
Valencia, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
University Hospitals Sussex NHS Foundation Trust - Royal Sussex County Hospital
Brighton, United Kingdom
King's College Hospital (KCH) NHS Foundation Trust
Brixton, United Kingdom