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ACTIVE NOT RECRUITING

NCT06625060

PHASE2

A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults

Sponsor: Ipsen

View on ClinicalTrials.gov

Summary

A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Migraines are caused by a series of events when the brain gets stimulated or activated, which causes the release of chemicals that cause pain. Corabotase (also known as IPN10200) is a medication that stops the release of these chemical messengers. Participants with episodic migraine (EM) or chronic migraine (CM) will be included in both Step 1 and Step 2. "Headache days" are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms. "Migraine days" occur when the headache displays clear migraine characteristics. This study aims to determine: * The safety and efficacy of injecting Corabotase directly into the muscles of the head and neck to prevent EM and CM, * The right amount (dose) of Corabotase to inject at each point, * The total amount (dose) of Corabotase that provides the best balance between safety and efficacy preventing migraines. Participants will need to complete a daily electronic migraine Diary (eDiary) and questionnaires throughout the study. The total study duration for a participant will be up to 44 weeks.

Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Dose Escalation and Dose Finding Phase II Study to Evaluate the Safety and Efficacy of IPN10200 in the Prevention of Episodic or Chronic Migraine in Adults

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

670

Start Date

2024-10-10

Completion Date

2027-10-31

Last Updated

2026-09-08

Healthy Volunteers

Conditions

Episodic Migraine Chronic Migraine

Interventions

BIOLOGICAL

Corabotase

Lyophilised powder

OTHER

Placebo

Excipients without active substance, Lyophilised powder

BIOLOGICAL

Corabotase dose A

Lyophilised powder

BIOLOGICAL

Corabotase dose B

Lyophilised powder

Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF. Participant has provided written informed consent and signed privacy/data protection documentation; 2. Male or female ≥18 to 80 years of age at the time of signing the informed consent; 3. Diagnosis of either EM or CM, per ICHD-3 criteria, for at least 12 months prior to the screening visit; 4. Diagnosis of migraine at ≤50 years of age; 5. Participants in the EM group: History of EM diagnosis and headache frequency (i.e. migraine and non-migraine headache): ≤14 headache days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary; migraine frequency: ≥6 migraine days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary; 6. Participants in the CM group: History of CM diagnosis and headache frequency (i.e. migraine and non-migraine headache): ≥15 headache days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary; migraine frequency: ≥8 migraine days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary; 7. Participant with a history of use of at least one preventive treatment for migraine. Exclusion Criteria: 1. 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; 2. Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache (MOH); 3. Current uncontrolled psychiatric or psychological condition, or one that could confound assessment of headaches/migraines or interfere with study participation; 4. Risk of self-harm or harm to others as evidenced by past suicidal behaviour or endorsing items 3, 4, or 5 on the C-SSRS at screening or Day 1. 5. Participants presenting with a swallowing disorder of any origin which might be exacerbated by botulinum toxin treatment, such as: \- Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing difficulties and requiring a change in diet. 6. Clinically relevant skin condition or infection that could interfere with injection of study intervention; 7. Participant has any medical condition or situation that would make them unsuitable for participation in the study; 8. Participant receiving more than one allowable concomitant migraine preventive treatment; 9. Known history of an inadequate response to \>4 medications prescribed for the prevention of migraine (2 of which have different mechanisms of action to botulinum toxin); 10. Use of any of the following medications in the specified timeframe prior to the screening visit: * Botulinum toxin for migraine within 24 weeks (or for any other medical/aesthetic reason within 16 weeks); * Prior use of mAbs blocking CGRP pathway within 12 weeks for preventative treatment of migraine * Prior use of oral CGRP receptor antagonist (gepants) for preventative treatment of migraine within 2 weeks; * Anaesthetic or steroid injection in any region targeted for treatment with study medication within 4 weeks; * Use of cannabidiol or other types of cannabinoids within 30 days; * Use of medical device to treat migraine within 4 weeks (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); * Use of other intervention to treat migraine that is assessed to interfere with study evaluations within 4 weeks (e.g. acupuncture in the head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments and dental splints for headache); * Use of opioids or barbiturates for more than 2 days/month within the last 4 weeks. 11. Concurrent participation in another interventional clinical study (or within specified timeframe according to national or local legislation or requirements); 12. Diagnosis of other significant pain disorders that could confound the assessment of headaches/migraines or interfere with study participation, including but not limited to chronic pain disorders such as fibromyalgia, chronic low back pain and complex regional pain syndrome; 13. Pregnant women, nursing women, premenopausal women, or WOCBP (i.e. not surgically sterile or 1 year postmenopausal) not willing to practice an acceptable contraceptive method, at the beginning of the study and for a minimum of 12 weeks following the administration of study treatment; 14. Male subjects who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide for a minimum of 12 weeks following the initial double-blind administration of the treatment; 15. History of alcohol or drug abuse within 5 years of the screening visit (excluding medication overuse for headache); 16. Body mass index (BMI) ≥35 kg/m² at the screening visit; 17. Known clinically significant hypersensitivity to any of the study drugs, excipients or materials used to administer the study drug; 18. Patients who, in the clinician's judgment, are actively suicidal, and therefore, deemed to be at significant risk for suicide. 19. A diagnosis of a neuromuscular disorder or respiratory disorder, such as myasthenia gravis, Lambert-Eaton syndrome or amyotrophic lateral sclerosis that in the opinion of the investigator would compromise the safety of the study participant.

Locations (162)

Central Research Associates

Birmingham, Alabama, United States

Rehabilitation & Neurological Services, LLC

Huntsville, Alabama, United States

MD First Research - Chandler - Neurology

Chandler, Arizona, United States

MD First Research - Chandler

Chandler, Arizona, United States

Axiom Research, LLC

Apple Valley, California, United States

Profound Research. LLC - NCSC

Carlsbad, California, United States

M3Wake -PRI Encino

Encino, California, United States

WR-PRI Encino

Encino, California, United States

Neuro-Pain Medical Center

Fresno, California, United States

Fullerton Neurological Center - Neurology

Fullerton, California, United States

Neurology Center of North Orange County

Fullerton, California, United States

Kaizen Brain Center

La Jolla, California, United States

Pharmacology Research Institute (PRI)

Los Alamitos, California, United States

Pharmacology Research Institute (PRI) - Los Alamitos/Long Beach

Newport Beach, California, United States

Profound Research, LLC

Pasadena, California, United States

Acclaim Clinical Research - Internal Medicine

San Diego, California, United States

Clinical Trials Management LLC

Thousand Oaks, California, United States

Alliance Clinical West Hills (Focus Clinical Research)

West Hills, California, United States

Advanced Neuroscience Research Center, LLC

Fort Collins, Colorado, United States

Advanced Neuroscience Research Center, LLC - Neurology

Fort Collins, Colorado, United States

New England Institute for Neurology and Headache (NEINH)/Medical Practice

Stamford, Connecticut, United States

Neurology Offices

Boca Raton, Florida, United States

AGA Clinical Trials

Hialeah, Florida, United States

M3 Wake Research/MSRA, LLC

Lake City, Florida, United States

M3 Wake Research/MSRA,LLC

Lake City, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Emerald Coast Center For Neurological Disorders

Pensacola, Florida, United States

Conquest Research

Winter Park, Florida, United States

NeuroTrials Research, Inc.

Atlanta, Georgia, United States

Crescent City Headache and Neurology Center, LLC

Chalmette, Louisiana, United States

Ochsner Health Center - Covington

Covington, Louisiana, United States

DelRicht Research

New Orleans, Louisiana, United States

DelRicht Research at Touro Medical Center

New Orleans, Louisiana, United States

LSU Healthcare Network Orthopedic & Sports Medicine

New Orleans, Louisiana, United States

MedStar Neurosciences and Rehabilitation Research Network

Baltimore, Maryland, United States

MedStar Neurosciences and Rehabilitation

Baltimore, Maryland, United States

MedStar Franklin Square Hospital Center

Baltimore, Maryland, United States

Medstar Franklin Square Medical Center

Baltimore, Maryland, United States

Neurology Center of NE,PC - Neurology

Foxborough, Massachusetts, United States

MedVadis Research

Waltham, Massachusetts, United States

Mass Institute of Clinical Research

Westborough, Massachusetts, United States

Michigan Head Pain & Neurological Institute - Neurology/Pain

Ann Arbor, Michigan, United States

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan, United States

Michigan Center of Medical Research

Grand Blanc, Michigan, United States

Minneapolis Clinic-Neurology

Burnsville, Minnesota, United States

Papillion Research Center/Avacare

Papillion, Nebraska, United States

Alliance Clinical Las Vegas (Excel Clinical Research) - Internal Medicine

Las Vegas, Nevada, United States

Integrative Clinical Trials, LLC

Brooklyn, New York, United States

Montefiore Medical Center: Headache Center

The Bronx, New York, United States

Upstate Clinical Research Associates - Research Center

Williamsville, New York, United States

Upstate Clinical Research Associates

Williamsville, New York, United States

UC Gardner Neuroscience Institute

Cincinnati, Ohio, United States

Neurology Diagnostics, Inc.

Dayton, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Preferred Primary Care Physicians - Curry Hollow

Pittsburgh, Pennsylvania, United States

Clinical Neuroscience Solutions, Inc - Memphis

Memphis, Tennessee, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Zenos Clinical Research - Internal Medicine

Dallas, Texas, United States

Lone Star Neurology

Frisco, Texas, United States

Elevate Clinical Research - Houston

Houston, Texas, United States

Javara Inc. - Houston, TX

Houston, Texas, United States

Javara Inc. - New Caney, TX

New Caney, Texas, United States

J. Lewis Research-Site Number:8400053

Salt Lake City, Utah, United States

ChronicleBio

West Valley City, Utah, United States

Puget Sound Neurology - Neurology

Tacoma, Washington, United States

Marshall Health Clinical Research Center

Huntington, West Virginia, United States

Frontier Clinical Research, LLC - Kingwood

Kingwood, West Virginia, United States

The Alfred Hospital - Neurology

Melbourne, Australia

Western Health - Neurology & Stroke Services

Saint Albans, Australia

The Royal Melbourne Hospital - Neurology

Victoria Park, Australia

Instituto de Neurologia de Curitiba

Paraná, Brazil

Associação Hospitalar Moinhos de Vento

Rio Grande, Brazil

A2Z Clinical

São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil

Pseg Centro de Pesquisa Clínica S.A

São Paulo, Brazil

CaRe Clinic - Calgary

Calgary, Canada

University of Calgary Foothills Campus

Calgary, Canada

Centre de Recherche Saint-Louis (Lévis) - Clinique Neuro-Lévis

Lévis, Canada

Centre de Recherche Saint-Louis (Quebec) - Clinique Médicale Saint-Louis

Québec, Canada

CaRe Clinic Red Deer

Red Deer, Canada

Bluewater Clinical Research Group Inc.

Sarnia, Canada

Pratia Brno s.r.o.

Brno, Czechia

NEUROHK s.r.o.

Choceň, Czechia

NeuropsychiatrieHK, s.r.o.

Hradec Králové, Czechia

Fakultni nemocnice Ostrava - Neurologicka klinika

Ostrava, Czechia

Pratia Pardubice a.s.

Pardubice, Czechia

AXON clinical

Prague, Czechia

DADO MEDICAL s.r.o.

Prague, Czechia

CHU Amiens Sud-Centre Rech Clinique

Amiens, France

Centre Hospitalier Regional Universtaire De Clermont-Ferrand - Neurologie

Clermont-Ferrand, France

CHU de Nantes - HÃ´pital Laennec - Neurology

Nantes, France

CHU Nimes - Hôpital Caremeau - Service de Neurologie

Nîmes, France

Assistance Publique-Hopitaux de Paris (AP-HP) - Unite de Recherche Clinique Saint-Louis Lariboisere-Ferd Widal

Paris, France

Ltd "Health"

Batumi, Georgia

"Pineo Medical Ecosystem" LTD

Tbilisi, Georgia

LTD "Israel-Georgian Medical Research Clinic Healthycore"

Tbilisi, Georgia

LTD "Multiprofile Clinic Consilium Medulla"

Tbilisi, Georgia

LTD New Hospitals - Neurology

Tbilisi, Georgia

Ltd. S.Khechinashvili University Clinic

Tbilisi, Georgia

And 62 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (162)