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NCT06047457 | RECRUITING | Episodic Migraine

A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults
Sponsor:

Ipsen

Brief 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).

Condition or disease

Episodic Migraine

Intervention/treatment

Botulinum toxin type A

Botulinum toxin type A

Placebo

Botulinum toxin type A

Botulinum toxin type A

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 714 participants
Masking : DOUBLE
Primary Purpose : PREVENTION
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 Episodic Migraine in Adult Participants
Actual Study Start Date : 2023-09-29
Estimated Primary Completion Date : 2026-06-22
Estimated Study Completion Date : 2026-12-21

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
Exclusion Criteria
  • * History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache.
  • * Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache, which is permitted.
  • * Use of any of the following medications in the specified timeframe prior to start of the screening daily headache eDiary
    • * a. Within 24 weeks
    • * i. Botulinum toxin for migraine (or for any other medical/aesthetic reason within 16 weeks)
    • * b. Within 12 weeks
    • * i. CGRP antagonists (monoclonal antibody or gepant) for preventive treatment of migraine (acute treatment of headache/migraine with a gepant is permitted, but limited to no more than 6 days per month (i.e. 6 days per each 4-week period with gepant intake))
    • * ii. Cannabinol or other types of cannabinoids
    • * c. Within 4 weeks
    • * i. Anaesthetic or steroid injection in any region targeted for injection with study intervention
    • * ii. Use of medical device to treat migraine (e.g. non-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation, and peripheral neuroelectrical stimulation)
    • * iii. Other interventions for migraine assessed to interfere with study evaluations (e.g. acupuncture in head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments, and dental splints for headache) iv. Use of opioids or barbiturates for more than 2 days/month.
    • Note: participants are permitted to take one concomitant migraine preventative treatment (not listed above); however, the dose of this medication should be stable for ≥3 months before start of the screening eDiary.
    • • Known history of treatment failure to more than four medications prescribed for the prevention of migraine (two of which have different mechanisms of action) or known history of treatment failure to botulinum toxin prescribed for the prevention of migraine.
A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults

Location Details

NCT06047457

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

Central Research Associates

Birmingham, Albama, United States, 35205

NOT YET RECRUITING

United States, Arizona

CCT Research

Phoenix, Arizona, United States, 85044

RECRUITING

United States, Arizona

HonorHealth Neurology

Scottsdale, Arizona, United States, 85251

WITHDRAWN

United States, Arizona

Alliance for Multispecialty Research (AMR) Phoenix

Tempe, Arizona, United States, 85281

RECRUITING

United States, California

Fullerton Neurological Center

Fullerton, California, United States, 92835

RECRUITING

United States, California

Neurology Center of North Orange County

Fullerton, California, United States, 92835

RECRUITING

United States, California

SDS Clinical Trials

Orange, California, United States, 92868

RECRUITING

United States, California

The Los Angeles Headache Center

Savannah, California, United States, 31406

NOT YET RECRUITING

United States, Connecticut

Stomach neurology

New Haven, Connecticut, United States, 06511

RECRUITING

United States, Florida

Visionary Investigators Network (VIN)

Aventura, Florida, United States, 33180

RECRUITING

United States, Florida

AGA Clinical Trials

Hialeah, Florida, United States, 33012

RECRUITING

United States, Florida

Infinity Clinical Research, LLC

Hollywood, Florida, United States, 33024

NOT YET RECRUITING

United States, Florida

840042

Miami, Florida, United States, 33136

TERMINATED

United States, Florida

Guardian Angel Research Center

Tampa, Florida, United States, 33614

RECRUITING

United States, Florida

Boston Clinical Trials Inc

Winter Park, Florida, United States, 32131

RECRUITING

United States, Florida

Conquest Research

Winter Park, Florida, United States, 32789

WITHDRAWN

United States, Georgia

CenExel iResearch Atlanta, LLC

Decatur, Georgia, United States, 30030

WITHDRAWN

United States, Georgia

Velocity Clinical Research, Savanah

Savannah, Georgia, United States, 31406

NOT YET RECRUITING

United States, Illinois

Chicago Headache Center & Research Institute

Chicago, Illinois, United States, 60657

TERMINATED

United States, Illinois

Robbins Headache Clinic

Riverwoods, Illinois, United States, 60015

RECRUITING

United States, Indiana

MD Fort Wayne Neurological Center

Fort Wayne, Indiana, United States, 46804

RECRUITING

United States, Maryland

Comprehensive Neurology Services

Frederick, Maryland, United States, 21702

RECRUITING

United States, Massachusetts

Boston Clinical Trials Inc

Boston, Massachusetts, United States, 02131

NOT YET RECRUITING

United States, Massachusetts

Beth Israel Deaconess Medical Center - Arnold Pain Management

Brookline, Massachusetts, United States, 02115

RECRUITING

United States, Massachusetts

Neurology Center of NE,PC - Neurology

Foxboro, Massachusetts, United States, 02035

RECRUITING

United States, Massachusetts

Lone Star Neurology,

Westborough, Massachusetts, United States, 01581

RECRUITING

United States, Massachusetts

New England Regional Headache Center, Inc.

Worcester, Massachusetts, United States, 01609

RECRUITING

United States, Road cancer

Quest Research Institute

Farmington Hills, Road cancer, United States, 48334

RECRUITING

United States, Minnesota

Minneapolis Clinic of Neurology

Burnsville, Minnesota, United States, 55337

WITHDRAWN

United States, Missouri

Clinical Research Professionals

Chesterfield, Missouri, United States, 63005

RECRUITING

United States, New York

SPRI Clinical Trials, LLC

Brooklyn, New York, United States, 11235

RECRUITING

United States, New York

Nuvance Health Medical Practice

Poughkeepsie, New York, United States, 12601

RECRUITING

United States, New York

Rochester Clinical Research

Rochester, New York, United States, 14609

RECRUITING

United States, North Carolina

Asheville Neurology Specialists

Asheville, North Carolina, United States, 28806

RECRUITING

United States, North Carolina

Headache Wellness Center

Greensboro, North Carolina, United States, 27405

TERMINATED

United States, North Carolina

Blue Sky MD

Hendersonville, North Carolina, United States, 28792

NOT YET RECRUITING

United States, Ohio

Headache Center of Hope

Cincinnati, Ohio, United States, 45236

ACTIVE NOT RECRUITING

United States, Ohio

The Orthopedic Foundation - Clinic

New Albany, Ohio, United States, 43054

RECRUITING

United States, Pennsylvania

Suburban Research Associates

Media, Pennsylvania, United States, 19063

RECRUITING

United States, Pennsylvania

Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, South Carolina

Coastal Carolina Research Center - North Charleston

North Charleston, South Carolina, United States, 29405

NOT YET RECRUITING

United States, Tennessee

Neurology Clinic, PC

Cordova, Tennessee, United States, 38018

NOT YET RECRUITING

United States, Tennessee

KCA Neurology, PLLC

Franklin, Tennessee, United States, 37067

RECRUITING

United States, Texas

Herzog, Steven MD

Dallas, Texas, United States, 75214

WITHDRAWN

United States, Texas

N TX Inst of Neurology & Headache

Frisco, Texas, United States, 75034

NOT YET RECRUITING

United States, Texas

Lone Star Neurology

Frisco, Texas, United States, 75035

SUSPENDED

United States, Texas

Clinical Trial Network

Houston, Texas, United States, 77074

RECRUITING

United States, Texas

Research Your Health

Plano, Texas, United States, 75093

RECRUITING

United States, Utah

J. Lewis Research Inc.-Foothill

Salt Lake City, Utah, United States, 84109

RECRUITING

United States, Utah

Metrodora Institute

West Valley City, Utah, United States, 84119

RECRUITING

United States, Virginia

Inova Medical Group - Neurology

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Washington

MedStar Health - Department of Neurology

Columbia, Washington, United States, 20010

RECRUITING

United States, West Virginia

Frontier Clinical Research, LLC

Kingwood, West Virginia, United States, 26537

RECRUITING

Canada,

Genge Partners Inc.

Montréal, Canada, H3A 2B4

RECRUITING

Canada,

CARe Clinic-Calgary

Red Deer, Canada,

RECRUITING

Canada,

Bluewater Clinical Research Group Inc.

Sarnia, Canada, N7T 4X3

RECRUITING

Czechia,

Neurologie Brno s.r.o.

Brno, Czechia,

RECRUITING

Czechia,

Pratia Brno s.r.o.

Brno, Czechia,

RECRUITING

Czechia,

NEUROHK s.r.o.

Chocen, Czechia,

RECRUITING

Czechia,

Hospital Jihlava, p.o.

Jihlava, Czechia,

RECRUITING

Czechia,

Faculty Hospital Ostrava

Ostrava, Czechia,

RECRUITING

Czechia,

Institut neuropsychiatric furnaces

Prague 8, Czechia,

RECRUITING

Czechia,

Axon Clinical, s.r.o.

Prague, Czechia,

RECRUITING

Czechia,

Medical Data S.R.O.

Prague, Czechia,

RECRUITING

Czechia,

Faculty Thomayer Hospital

Prague, Czechia,

RECRUITING

France,

Amiens Chru

Amiens, France,

RECRUITING

France,

CHU Nimes - Caremeau Hospital

Nîmes, France,

RECRUITING

France,

Public assistance-hopitals of Paris (AP-HP)-Unite of clinical research Saint-Louis Laribisere-Ferd Widal

Paris, France,

ACTIVE NOT RECRUITING

Georgia,

Ltd "Health"

Batumi, Georgia, 6010

ACTIVE NOT RECRUITING

Georgia,

"Pineo Medical Ecosystem" LTD

Tbilisi, Georgia, 0114

ACTIVE NOT RECRUITING

Georgia,

LTD New Hospitals

Tbilisi, Georgia, 0114

ACTIVE NOT RECRUITING

Georgia,

LTD S.Khechinashvili University Hospital

Tbilisi, Georgia, 0179

ACTIVE NOT RECRUITING

Georgia,

Multprofil clinic policy spinal

Tbilisi, Georgia, 0186

RECRUITING

Georgia,

ISR-GEO Med Res Clin Healthycore

Tbilisi, Georgia,

RECRUITING

Germany,

Charité - University Medicine Berlin Kör

Berlin, Germany,

RECRUITING

Germany,

Emovis GmbH

Berlin, Germany,

RECRUITING

Germany,

University Medicine Greifswald

Greifswald, Germany,

RECRUITING

Germany,

Headache center Frankfurt am Main

Hesse, Germany,

RECRUITING

Germany,

LMU - Clinic of the University of Munich - Campus Grosshadern

München, Germany,

RECRUITING

Poland,

Medical Center Neuromed Pawel Lisewski

Bydgoszcz, Poland,

RECRUITING

Poland,

Synexus Polska Sp. z o.o.

Gdynia, Poland,

RECRUITING

Poland,

Medical Center Pratia Katowice

Katowice, Poland,

RECRUITING

Poland,

Kraków Akademia Neurology Sp. z o.o.

Krakow, Poland,

RECRUITING

Poland,

Krakowskie Centrum Medyczne Sp.z o.o

Krakow, Poland,

RECRUITING

Poland,

Winging MCM Krakow

Krakow, Poland,

RECRUITING

Poland,

Individual medical practice dr hab. med. Anna Szczepanska-Szerej

Lublin, Poland,

RECRUITING

Poland,

Institute of Health Dr. Boczarska-Jewin Sp. z o.o. S.K.

Oświęcim, Poland,

NOT YET RECRUITING

Spain,

Vall d Hebron University Hospital

Barcelona, Spain,

RECRUITING

Spain,

Ruber Juan Bravo hospital complex

Madrid, Spain,

RECRUITING

Spain,

October 12 University Hospital

Madrid, Spain,

RECRUITING

Spain,

Regional University Hospital of Malaga

Málaga, Spain,

RECRUITING

Spain,

La Fe University and Polytechnic Hospital

Valencia, Spain,

WITHDRAWN

Spain,

Lozano Blesa University Clinic Hospital

Zaragoza, Spain,