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New shot aims to stop migraines before they start

NCT ID NCT06625060

Prevention Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 7 times

Summary

This study tests a new medication called IPN10200, given as injections into the head and neck muscles, to prevent migraines in adults. About 641 people with episodic or chronic migraine will receive either the drug or a placebo. The goal is to see if it safely reduces the number of migraine days and to find the best dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IPN10200 (a biologic injected into head and neck muscles to block pain signals)
What this could lead to
If it works, this could provide a new option for preventing migraines, reducing the number of headache days for people with episodic or chronic migraine.
What could go wrong
This is an early phase 2 trial, so the drug may not prove effective or safe. Side effects, including allergic reactions or injection-site issues, are possible. The results may not apply to all migraine patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

670 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic migraine Episodic migraine

Contacts and locations

Locations

  • "Pineo Medical Ecosystem" LTD

    Tbilisi, Georgia

  • A2Z Clinical

    São Paulo, Brazil

  • AGA Clinical Trials

    Hialeah, Florida, 33012, United States

  • AXON clinical

    Prague, Czechia

  • Acclaim Clinical Research - Internal Medicine

    San Diego, California, 92101, United States

  • Advanced Neuroscience Research Center, LLC

    Fort Collins, Colorado, 80501, United States

  • Advanced Neuroscience Research Center, LLC - Neurology

    Fort Collins, Colorado, 80524, United States

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

    Las Vegas, Nevada, 89101, United States

  • Alliance Clinical West Hills (Focus Clinical Research)

    West Hills, California, 91307, United States

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

    Paris, France

  • Associação Hospitalar Moinhos de Vento

    Rio Grande, Brazil

  • Axiom Research, LLC

    Apple Valley, California, 92308, United States

  • Bluewater Clinical Research Group Inc.

    Sarnia, Canada

  • CHU Amiens Sud-Centre Rech Clinique

    Amiens, France

  • CHU Nimes - Hôpital Caremeau - Service de Neurologie

    Nîmes, France

  • CHU de Nantes - Hôpital Laennec - Neurology

    Nantes, France

  • CM Linden

    Krakow, Poland

  • CaRe Clinic - Calgary

    Calgary, Canada

  • CaRe Clinic Red Deer

    Red Deer, Canada

  • Central Research Associates

    Birmingham, Alabama, 35205, United States

  • Centre Hospitalier Regional Universtaire De Clermont-Ferrand - Neurologie

    Clermont-Ferrand, France

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

    Lévis, Canada

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

    Québec, Canada

  • Centrum Leczenia Zaburzen Pamieci i Neuroobrazowania Affidea

    Warsaw, Poland

  • Centrum Medyczne PROMED

    Krakow, Poland

  • Charite - Universitaetsmedizin Berlin - Neurology

    Berlin, Germany

  • ChronicleBio

    West Valley City, Utah, 84119, United States

  • City Clinic Research Sp. z o.o.

    Warsaw, Poland

  • Clinical Neuroscience Solutions, Inc - Memphis

    Memphis, Tennessee, 38119, United States

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119, United States

  • Clinical Trials Management LLC

    Thousand Oaks, California, 91360, United States

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Crescent City Headache and Neurology Center, LLC

    Chalmette, Louisiana, 70043, United States

  • DADO MEDICAL s.r.o.

    Prague, Czechia

  • DOI Internal Medicine/Neurology Clinic

    Hiroshima, Japan

  • DelRicht Research

    New Orleans, Louisiana, 70112, United States

  • DelRicht Research at Touro Medical Center

    New Orleans, Louisiana, 70115, United States

  • ETG Neuroscience Sp. z o.o.

    Warsaw, Poland

  • ETG Siedlce

    Siedlce, Poland

  • Elevate Clinical Research - Houston

    Houston, Texas, 77002, United States

  • Emerald Coast Center For Neurological Disorders

    Pensacola, Florida, 32502, United States

  • Ewha Womans University Seoul Hospital - Neurology

    Seoul, South Korea

  • Fakultni nemocnice Ostrava - Neurologicka klinika

    Ostrava, Czechia

  • Frontier Clinical Research, LLC - Kingwood

    Kingwood, West Virginia, 26537, United States

  • Fullerton Neurological Center - Neurology

    Fullerton, California, 92832, United States

  • FutureMeds Berlin (emovis)

    Berlin, Germany

  • FutureMeds Krakow

    Krakow, Poland

  • FutureMeds Lodz

    Lodz, Poland

  • FutureMeds Madrid

    Madrid, Spain

  • FutureMeds Spain Cádiz

    Cadiz, Spain

  • Hallym University Dongtan Sacred Heart Hospital - Neurology

    Gyeonggi-do, South Korea

  • Hospital Alemao Oswaldo Cruz

    São Paulo, Brazil

  • Hospital Clinic de Barcelona - Neurología

    Barcelona, Spain

  • Hospital Clinico Universitario de Valladolid - Gastroenterology

    Valladolid, Spain

  • Hospital Universitario Marqués de Valdecilla - Neurologia

    Santander, Spain

  • Hospital Universitario Vall d'Hebron - Enfermedades Infecciosas

    Barcelona, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hull University Teaching Hospitals NHS Trust - Hull Royal Infirmary

    Hull, United Kingdom

  • Ikeda Neurosurgical Clinic - Neurosurgery

    Fukuoka, Japan

  • Inje University Ilsan Paik Hospital - Allergology

    Gyeonggi-do, South Korea

  • Instituto de Neurologia de Curitiba

    Paraná, Brazil

  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.

    Oświęcim, Poland

  • Integrative Clinical Trials, LLC

    Brooklyn, New York, 11229, United States

  • Ishikawa Clinic

    Kyoto, Japan

  • Iwata Neurosurgery Clinic

    Tokyo, Japan

  • J. Lewis Research-Site Number:8400053

    Salt Lake City, Utah, 84101, United States

  • Japanese Red Cross Shizuoka Hospital - Neurology

    Shizuoka, Japan

  • Javara Inc. - Houston, TX

    Houston, Texas, 77002, United States

  • Javara Inc. - New Caney, TX

    New Caney, Texas, 77357, United States

  • Kaizen Brain Center

    La Jolla, California, 92037, United States

  • Kangbuk Samsung Hospital - Neurology

    Seoul, South Korea

  • King's College Hospital

    London, United Kingdom

  • Kitasato University Kitasato Institute Hospital - Urology - Neurology

    Tokyo, Japan

  • Konankai Konan Medical Center - Neurology

    Hyōgo, Japan

  • Kopfschmerzzentrum Frankfurt

    Frankfurt, Germany

  • LSU Healthcare Network Orthopedic & Sports Medicine

    New Orleans, Louisiana, 70115, United States

  • LTD "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi, Georgia

  • LTD "Multiprofile Clinic Consilium Medulla"

    Tbilisi, Georgia

  • LTD New Hospitals - Neurology

    Tbilisi, Georgia

  • Lakeland Clinical Trials Wellington

    Upper Hutt, New Zealand

  • Lone Star Neurology

    Frisco, Texas, 75034, United States

  • Ltd "Health"

    Batumi, Georgia

  • Ltd. S.Khechinashvili University Clinic

    Tbilisi, Georgia

  • M3 Wake Research/MSRA, LLC

    Lake City, Florida, 32055, United States

  • M3 Wake Research/MSRA,LLC

    Lake City, Florida, 32055, United States

  • M3Wake -PRI Encino

    Encino, California, 91316, United States

  • MD First Research - Chandler

    Chandler, Arizona, 85286, United States

  • MD First Research - Chandler - Neurology

    Chandler, Arizona, 85224, United States

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, Poland

  • Marshall Health Clinical Research Center

    Huntington, West Virginia, 25701, United States

  • Mass Institute of Clinical Research

    Westborough, Massachusetts, 01581, United States

  • MedStar Franklin Square Hospital Center

    Baltimore, Maryland, 21237, United States

  • MedStar Neurosciences and Rehabilitation

    Baltimore, Maryland, 21218, United States

  • MedStar Neurosciences and Rehabilitation Research Network

    Baltimore, Maryland, 21218, United States

  • MedVadis Research

    Waltham, Massachusetts, 02451, United States

  • Medstar Franklin Square Medical Center

    Baltimore, Maryland, 21237, United States

  • Michigan Center of Medical Research

    Grand Blanc, Michigan, 48439, United States

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan, 48104, United States

  • Michigan Head Pain & Neurological Institute - Neurology/Pain

    Ann Arbor, Michigan, 48104, United States

  • Minneapolis Clinic-Neurology

    Burnsville, Minnesota, 55306, United States

  • Montefiore Medical Center: Headache Center

    The Bronx, New York, 10461, United States

  • NEUROHK s.r.o.

    Choceň, Czechia

  • Nagamitsu Clinic - Neurology

    Yamaguchi, Japan

  • Neuro-Pain Medical Center

    Fresno, California, 93710, United States

  • NeuroPoint

    Ulm, Germany

  • NeuroTrials Research, Inc.

    Atlanta, Georgia, 30309, United States

  • Neurology Center of NE,PC - Neurology

    Foxborough, Massachusetts, 02035, United States

  • Neurology Center of North Orange County

    Fullerton, California, 92832, United States

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459, United States

  • Neurology Offices

    Boca Raton, Florida, 33432, United States

  • NeuropsychiatrieHK, s.r.o.

    Hradec Králové, Czechia

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

    Stamford, Connecticut, 06901, United States

  • New Zealand Brain Research Institute at University of Otago

    Christchurch, New Zealand

  • Nowon Eulji Medical Center, Eulji University - Neurology

    Seoul, South Korea

  • Ochsner Health Center - Covington

    Covington, Louisiana, 70433, United States

  • Optimal Clinical Trials

    Auckland, New Zealand

  • Optimal Clinical Trials - Christchurch

    Christchurch, New Zealand

  • Pacific Clinical Research Network (PCRN) - Auckland

    Takapuna, New Zealand

  • Pacific Clinical Research Network (PCRN) - Christchurch

    Christchurch, New Zealand

  • Pacific Clinical Research Network (PCRN) - Tasman

    Nelson, New Zealand

  • Papillion Research Center/Avacare

    Papillion, Nebraska, 68046, United States

  • Pharmacology Research Institute (PRI)

    Los Alamitos, California, 90720, United States

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

    Newport Beach, California, 92660, United States

  • Pratia Brno s.r.o.

    Brno, Czechia

  • Pratia Pardubice a.s.

    Pardubice, Czechia

  • Praxis Dr. Oehlwein

    Gera, Germany

  • Preferred Primary Care Physicians - Curry Hollow

    Pittsburgh, Pennsylvania, 15236, United States

  • Profound Research, LLC

    Pasadena, California, 91105, United States

  • Profound Research. LLC - NCSC

    Carlsbad, California, 92011, United States

  • Pseg Centro de Pesquisa Clínica S.A

    São Paulo, Brazil

  • Puget Sound Neurology - Neurology

    Tacoma, Washington, 98409, United States

  • Rehabilitation & Neurological Services, LLC

    Huntsville, Alabama, 35801, United States

  • Renstar Medical Research

    Ocala, Florida, 34471, United States

  • Royal Devon And Exeter Hospital - Neurology

    Exeter, United Kingdom

  • Schmerz- und Palliativzentrum Goeppingen

    Göppingen, Germany

  • Sendai Zutsu No-Shinkei Clinic - Neurology

    Miyagi, Japan

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Silmedic sp. z o.o.

    Katowice, Poland

  • Specjalistyczne Gabinety Sp. z o.o.

    Krakow, Poland

  • Synexus Katowice

    Katowice, Poland

  • Synexus Polska Sp. z o.o.

    Częstochowa, Poland

  • Synexus Polska Sp. z o.o. - Oddzial w Gdyni

    Pomorskie, Poland

  • Tanaka Neurosurgery & Headache Clinic

    Kagoshima, Japan

  • The Alfred Hospital - Neurology

    Melbourne, Australia

  • The Royal Melbourne Hospital - Neurology

    Victoria Park, Australia

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tominaga Clinic - Neurology

    Osaka, Japan

  • UC Gardner Neuroscience Institute

    Cincinnati, Ohio, 45219, United States

  • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden - UniversitaetsSchmerzCentrum - USC

    Dresden, Germany

  • Universitaetsmedizin Greifswald

    Greifswald, Germany

  • University of Calgary Foothills Campus

    Calgary, Canada

  • Universitätsklinikum Essen (AöR)

    Essen, Germany

  • Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach

    Katowice, Poland

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221, United States

  • Upstate Clinical Research Associates - Research Center

    Williamsville, New York, 14221, United States

  • Velocity Nova Sp. z o.o - Velocity Pulawy

    Puławy, Poland

  • WR-PRI Encino

    Encino, California, 91316, United States

  • Walton Centre For Neurology And Neurosurgery

    Liverpool, United Kingdom

  • Western Health - Neurology & Stroke Services

    Saint Albans, Australia

  • Zenos Clinical Research - Internal Medicine

    Dallas, Texas, 75201, United States

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