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

Status: Recruiting
Location: See all (119) 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 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).

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

• Participant 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 chronic migraine 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) ≥15 and baseline number of monthly migraine days (MMD) of ≥8, 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
RECRUITING
Birmingham
Arizona
CCT Research
RECRUITING
Phoenix
HonorHealth Neurology
RECRUITING
Scottsdale
Alliance for Multispecialty Research (AMR) Phoenix
WITHDRAWN
Tempe
California
Hope Clinical Research, LLC
RECRUITING
Canoga Park
Axiom Research LLC
NOT_YET_RECRUITING
Colton
Fullerton Neurological Center
RECRUITING
Fullerton
Neurology Center of North Orange County
RECRUITING
Fullerton
The Los Angeles Headache Center
RECRUITING
Los Angeles
SDS Clinical Trials
RECRUITING
Orange
840011
NOT_YET_RECRUITING
Palo Alto
Stanford University School of Medicine - Stanford Cardiovascular Institute (CVI)
RECRUITING
Palo Alto
Alliance Clinical San Diego (Acclaim Clinical Research)
RECRUITING
San Diego
Colorado
University of Colorado Hospital - Neurology Clinic
TERMINATED
Aurora
Connecticut
Yale University School of Medicine
RECRUITING
East Hartford
Hasbani Neurology
RECRUITING
New Haven
New England Institute for Neurology and Headache (NEINH)/Medical Practice
RECRUITING
Stamford
Florida
Visionary Investigators Network (VIN)
RECRUITING
Aventura
Velocity Clinical Research - Hallandale Beach
NOT_YET_RECRUITING
Hallandale
AGA Clinical Trials
RECRUITING
Hialeah
Infinity Clinical Research, LLC
RECRUITING
Hollywood
Neurology Clinical Research, Inc.
SUSPENDED
Hollywood
Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC)
NOT_YET_RECRUITING
Jacksonville
University of Miami Leonard M. Miller School of Medicine - Professional Arts Center
RECRUITING
Miami
Quantum Clinical Trials
RECRUITING
Miami Beach
Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry)
RECRUITING
Orlando
Guardian Angel Research Center
TERMINATED
Tampa
USF Health-Morsani Center
RECRUITING
Tampa
Conquest Research
RECRUITING
Winter Park
Georgia
Headache Wellness Center
SUSPENDED
Greensboro
Velocity Clinical Research - Savannah Neurology Specialists
WITHDRAWN
Savannah
Illinois
Cedar Crosse Research Center
NOT_YET_RECRUITING
Chicago
Chicago Headache Center & Research
RECRUITING
Chicago
Robbins Headache Clinic
TERMINATED
Riverwoods
Indiana
MD Fort Wayne Neurological Center
RECRUITING
Fort Wayne
Massachusetts
Boston Clinical Trials Inc
RECRUITING
Boston
Beth Israel Deaconess Medical Center - Arnold Pain Management
NOT_YET_RECRUITING
Brookline
Neurology Center of NE,PC - Neurology
RECRUITING
Foxborough
Mass Institute of Clinical Research
RECRUITING
Westborough
New England Regional Headache Center, Inc.
SUSPENDED
Worcester
Maryland
CenExel iResearch Atlanta, LLC
WITHDRAWN
Frederick
Comprehensive Neurology Services
RECRUITING
Frederick
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
Minnesota
Minneapolis Clinic of Neurology
NOT_YET_RECRUITING
Burnsville
Missouri
Clinical Research Professionals
WITHDRAWN
Chesterfield
North Carolina
Duke University Medical Center
RECRUITING
Durham
Blue Sky MD
TERMINATED
Hendersonville
Nebraska
Papillion Research Center
RECRUITING
Papillion
Nevada
Alliance Clinical Las Vegas (Excel Clinical Research)
RECRUITING
Las Vegas
Neurology Center of Las Vegas - Neurology
WITHDRAWN
Las Vegas
New York
Dent Neurosciences Research Center, Inc.
TERMINATED
Amherst
SPRI Clinical Trials, LLC
RECRUITING
Brooklyn
Nuvance Health Medical Practice
RECRUITING
Poughkeepsie
Rochester Clinical Research
RECRUITING
Rochester
Ohio
Headache Center of Hope
RECRUITING
Cincinnati
OrthoNeuro
RECRUITING
New Albany
Helios Clinical Research
RECRUITING
Wooster
Oregon
Providence Neurological Specialties West
WITHDRAWN
Portland
Pennsylvania
Suburban Research Associates
SUSPENDED
Media
Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology
RECRUITING
Philadelphia
South Carolina
Coastal Carolina Research Center - North Charleston
RECRUITING
North Charleston
Tennessee
Neurology Clinic, PC
RECRUITING
Cordova
KCA Neurology, PLLC
RECRUITING
Franklin
Helios Clinical Research LLC (Helios CR, Inc. Jackson TN)
RECRUITING
Jackson
Texas
Herzog, Steven MD
RECRUITING
Dallas
Texas Neurology
RECRUITING
Dallas
Zenos Clinical Research
RECRUITING
Dallas
Lone Star Neurology
RECRUITING
Frisco
North Texas Institute of Neurology & Headache
WITHDRAWN
Frisco
Clinical Trial Network
SUSPENDED
Houston
Research Your Health
RECRUITING
Plano
Utah
J. Lewis Research Inc.-Foothill
RECRUITING
Salt Lake City
Metrodora Institute
RECRUITING
West Valley City
Virginia
Inova Medical Group - Neurology
RECRUITING
Fairfax
Washington
MedStar Health - Department of Neurology
RECRUITING
Columbia
Wisconsin
BCN Research, LLC
RECRUITING
Greenfield
Neuroscience Group of Northeast Wisconsin-Neenah
RECRUITING
Neenah
West Virginia
Frontier Clinical Research, LLC
RECRUITING
Kingwood
Other Locations
Canada
Centricity Research Halifax Multispecialty
RECRUITING
Halifax
Genge Partners Inc.
RECRUITING
Montreal
CARe Clinic-Calgary
RECRUITING
Red Deer
Bluewater Clinical Research Group Inc.
RECRUITING
Sarnia
Royal Julilee Hospital
RECRUITING
Victoria
Georgia
Ltd Health
ACTIVE_NOT_RECRUITING
Batumi
ISR-GEO Med Res Clin Healthycore
ACTIVE_NOT_RECRUITING
Tbilisi
LTD New Hospitals
ACTIVE_NOT_RECRUITING
Tbilisi
LTD S.Khechinashvili University Hospital
ACTIVE_NOT_RECRUITING
Tbilisi
Multprofil Clinic Consilium Medulla
ACTIVE_NOT_RECRUITING
Tbilisi
Pineo Medical Ecosystem LTD
ACTIVE_NOT_RECRUITING
Tbilisi
Germany
Charité - Universitätsmedizin Berlin KöR
RECRUITING
Berlin
Emovis GmbH
RECRUITING
Berlin
Universitätsmedizin Greifswald
RECRUITING
Greifswald
Curiositas ad sanum Studien- und Beratungs GmbH Haag i.OB
RECRUITING
Haag In Oberbayern
Vitos Orthopaedische Klinik Kassel
RECRUITING
Kassel
LMU - Klinikum der Universität München - Campus Grosshadern
RECRUITING
München
Italy
Ospedale Bellaria, IRCCS Istituto delle Scienze Neurologiche, AUSL di Bologna
RECRUITING
Bologna
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
RECRUITING
Napoli
IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione
RECRUITING
Pavia
Istituto Neurologico Mediterraneo - NEUROMED, Istituto di Ricovero e Cura a Carattere Scientifico
RECRUITING
Pozzilli
IRCCS San Raffaele Pisana
RECRUITING
Roma
PU Campus Bio-Medico di Roma
RECRUITING
Roma
Poland
Centrum Medyczne Neuromed Pawel Lisewski
ACTIVE_NOT_RECRUITING
Bydgoszcz
Synexus Polska Sp. z o.o.
ACTIVE_NOT_RECRUITING
Gdynia
Centrum Medyczne Pratia Katowice
ACTIVE_NOT_RECRUITING
Katowice
Krakowska Akademia Neurologii Sp. z o.o.
ACTIVE_NOT_RECRUITING
Krakow
Krakowskie Centrum MedyczneSp.z o.o
ACTIVE_NOT_RECRUITING
Krakow
Pratia MCM Krakow
ACTIVE_NOT_RECRUITING
Krakow
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej
ACTIVE_NOT_RECRUITING
Lublin
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
ACTIVE_NOT_RECRUITING
Oświęcim
Spain
Hospital Universitario Reina Sofia
WITHDRAWN
Córdoba
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
TERMINATED
Madrid
Hospital Universitario Regional De Malaga
RECRUITING
Málaga
Hospital Universitario Virgen De La Macarena
RECRUITING
Seville
Hospital Clinico Universitario De Valencia
RECRUITING
Valencia
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Hospital Clinico Universitario Lozano Blesa
WITHDRAWN
Zaragoza
United Kingdom
University Hospitals Sussex NHS Foundation Trust - Royal Sussex County Hospital
RECRUITING
Brighton
King's College Hospital (KCH) NHS Foundation Trust
RECRUITING
Brixton
Contact Information
Primary
Ipsen Clinical Study Enquiries
clinical.trials@ipsen.com
See e mail
Time Frame
Start Date: 2023-10-12
Estimated Completion Date: 2026-12-21
Participants
Target number of participants: 720
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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