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 Episodic Migraine in Adult Participants

Status: Active_not_recruiting
Location: See all (96) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 3
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 be up to 60 weeks (approx. 14 months).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• must be ≥18 years of age inclusive, at the time of signing the informed consent and privacy/data protection documentation.

• Participant has a diagnosis for more than 12 months, prior to screening visit, of migraine with aura or migraine without aura according to the International Classification of Headache Disorders definition and diagnostic criteria

• Migraine onset occurred when participant was \<50 years of age.

• Has baseline number of monthly headache days (MHD) of \<15 and baseline number of monthly migraine days (MMD) of ≥6, using eDiary data collected during the 4 weeks nearest to randomisation on Day 1 (but prior to randomisation).

• Has baseline number of valid diary days ≥22 days collected during the 4 weeks nearest to randomisation on Day 1.

• Participant must have previously used, or is currently using, preventive treatment for migraine (pharmacological) (i.e. non-naïve) prior to start of screening eDiary

Locations
United States
Alabama
Central Research Associates
Birmingham
Arizona
CCT Research
Phoenix
HonorHealth Neurology
Scottsdale
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
Connecticut
Yale University School of Medicine
East Hartford
Hasbani Neurology
New Haven
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
Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry)
Orlando
Guardian Angel Research Center
Tampa
Boston Clinical Trials Inc
Winter Park
Conquest Research
Winter Park
Georgia
CenExel iResearch Atlanta, LLC
Decatur
Illinois
Cedar Crosse Research Center
Chicago
Chicago Headache Center & Research Institute
Chicago
Robbins Headache Clinic
Riverwoods
Indiana
MD Fort Wayne Neurological Center
Fort Wayne
Massachusetts
Boston Clinical Trials Inc
Boston
Beth Israel Deaconess Medical Center - Arnold Pain Management
Brookline
Neurology Center of NE,PC - Neurology
Foxborough
Lone Star Neurology,
Westborough
New England Regional Headache Center, Inc.
Worcester
Maryland
Comprehensive Neurology Services
Frederick
Michigan
Quest Research Institute
Farmington Hills
Minnesota
Minneapolis Clinic of Neurology
Burnsville
Missouri
Clinical Research Professionals
Chesterfield
North Carolina
Asheville Neurology Specialists
Asheville
Headache Wellness Center
Greensboro
Blue Sky MD
Hendersonville
Nevada
Alliance Clinical Las Vegas (Excel Clinical Research)
Las Vegas
M3 Wake Research - Las Vegas Wellness Way
Las Vegas
New York
SPRI Clinical Trials, LLC
Brooklyn
Nuvance Health Medical Practice
Poughkeepsie
Rochester Clinical Research
Rochester
Ohio
Headache Center of Hope
Cincinnati
OrthoNeuro
New Albany
Helios Clinical Research
Wooster
Pennsylvania
Suburban Research Associates
Media
Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology
Philadelphia
South Carolina
Coastal Carolina Research Center - North Charleston
North Charleston
Tennessee
Neurology Clinic, PC
Cordova
KCA Neurology, PLLC
Franklin
Helios Clinical Research LLC (Helios CR, Inc. Jackson TN)
Jackson
Texas
Herzog, Steven MD
Dallas
Zenos Clinical Research
Dallas
Lone Star Neurology
Frisco
Clinical Trial Network
Houston
Research Your Health
Plano
Utah
J. Lewis Research Inc.-Foothill
Salt Lake City
Metrodora Institute
West Valley City
Virginia
Inova Medical Group - Neurology
Fairfax
Washington
MedStar Health - Department of Neurology
Columbia
Wisconsin
BCN Research, LLC
Greenfield
Neuroscience Group of Northeast Wisconsin-Neenah
Neenah
West Virginia
Frontier Clinical Research, LLC
Kingwood
Other Locations
Canada
Genge Partners Inc.
Montreal
CARe Clinic-Calgary
Red Deer
Bluewater Clinical Research Group Inc.
Sarnia
France
CHRU d'Amiens
Amiens
CHU Nimes - Hôpital Caremeau
Nîmes
Assistance Publique-Hopitaux de Paris (AP-HP) - Unite de Recherche Clinique Saint-Louis Lariboisere-Ferd Widal
Paris
Georgia
Ltd Health
Batumi
ISR-GEO Med Res Clin Healthycore
Tbilisi
LTD New Hospitals
Tbilisi
LTD S.Khechinashvili University Hospital
Tbilisi
Multprofil Clinic Consilium Medulla
Tbilisi
Pineo Medical Ecosystem LTD
Tbilisi
Germany
Charité - Universitätsmedizin Berlin KöR
Berlin
Emovis GmbH
Berlin
Universitätsmedizin Greifswald
Greifswald
Kopfschmerzzentrum Frankfurt am Main
Hessen
LMU - Klinikum der Universität München - Campus Grosshadern
München
Poland
Centrum Medyczne Neuromed Pawel Lisewski
Bydgoszcz
Synexus Polska Sp. z o.o.
Gdynia
Centrum Medyczne Pratia Katowice
Katowice
Krakowska Akademia Neurologii Sp. z o.o.
Krakow
Krakowskie Centrum MedyczneSp.z o.o
Krakow
Pratia MCM Krakow
Krakow
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej
Lublin
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Oświęcim
Spain
Hospital Universitari Vall D Hebron
Barcelona
Complejo Hospitalario Ruber Juan Bravo
Madrid
Hospital Universitario 12 De Octubre
Madrid
Hospital Universitario Regional De Malaga
Málaga
Hospital Universitario y Politécnico La Fe
Valencia
Time Frame
Start Date: 2023-09-29
Completion Date: 2026-12-21
Participants
Target number of participants: 714
Treatments
Experimental: Dysport® dose A
Participant will receive four treatment cycles, each separated by an interval of 12 weeks.~Double-blind placebo-controlled (DBPC) Phase: Dysport® dose A administered intramuscularly on Day 1 and Week 12.~Extension Phase: Dysport® dose A administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48)
Experimental: Dysport® dose B
Participant will receive four treatment cycles, each separated by an interval of 12 weeks.~DBPC Phase: Dysport® dose B administered intramuscularly on Day 1 and Week 12.~Extension Phase: Dysport® dose B administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48)
Placebo_comparator: Placebo - Dysport dose A
Participant will receive four treatment cycles, each separated by an interval of 12 weeks.~DBPC Phase: Placebo dose A administered intramuscularly on Day 1 and Week 12.~Extension Phase: Dysport® dose A administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48).
Placebo_comparator: Placebo - Dysport dose B
Participant will receive four treatment cycles, each separated by an interval of 12 weeks.~DBPC Phase: Placebo dose B administered intramuscularly on Day 1 and Week 12.~Extension Phase: Dysport® dose B administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48).
Related Therapeutic Areas
Sponsors
Leads: Ipsen

This content was sourced from clinicaltrials.gov

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