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

September 3, 2026 updated by: Ipsen

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will consist of 3 periods:

  1. A 'screening period' to assess whether the participant can take part in the study.
  2. Step 1 is divided in two cohorts. The study will assess sequentially the safety of two doses of Corabotase, a lower dose in the cohort 1 and a higher dose in cohort 2. Participants will be administered with the study drug or placebo. The treatment is injected in muscles of the head, face and neck. The safety of participants is monitored throughout the 36 weeks at each cohort.
  3. Step 2: In this step, new eligible participants will be divided into two groups based on their diagnosis (EM or CM). These groups will then be randomly assigned to one of three intervention groups: Dose A, Dose B, or a placebo. The intervention will be given in a series of injections in muscles of the head, face and neck. Participants will be monitored for both efficacy and safety until they complete the Week 36 visit (the end of study).

Study Type

Interventional

Enrollment (Actual)

670

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • The Alfred Hospital - Neurology
      • Saint Albans, Australia
        • Western Health - Neurology & Stroke Services
      • Victoria Park, Australia
        • The Royal Melbourne Hospital - Neurology
  • Brazil
      • Paraná, Brazil
        • Instituto de Neurologia de Curitiba
      • Rio Grande, Brazil
        • Associacao Hospitalar Moinhos de Vento
      • São Paulo, Brazil
        • Hospital Alemao Oswaldo Cruz
      • São Paulo, Brazil
        • A2Z Clinical
      • São Paulo, Brazil
        • Pseg Centro de Pesquisa Clínica S.A
  • Canada
      • Calgary, Canada
        • CaRe Clinic - Calgary
      • Calgary, Canada
        • University of Calgary Foothills Campus
      • Lévis, Canada
        • Centre de Recherche Saint-Louis (Lévis) - Clinique Neuro-Lévis
      • Québec, Canada
        • Centre de Recherche Saint-Louis (Quebec) - Clinique Médicale Saint-Louis
      • Red Deer, Canada
        • CaRe Clinic Red Deer
      • Sarnia, Canada
        • Bluewater Clinical Research Group Inc.
  • Czechia
      • Brno, Czechia
        • Pratia Brno s.r.o.
      • Choceň, Czechia
        • NEUROHK s.r.o.
      • Hradec Králové, Czechia
        • NeuropsychiatrieHK, s.r.o.
      • Ostrava, Czechia
        • Fakultni nemocnice Ostrava - Neurologicka klinika
      • Pardubice, Czechia
        • Pratia Pardubice a.s.
      • Prague, Czechia
        • AXON clinical
      • Prague, Czechia
        • DADO MEDICAL s.r.o.
  • France
      • Amiens, France
        • CHU Amiens Sud-Centre Rech Clinique
      • Clermont-Ferrand, France
        • Centre Hospitalier Regional Universtaire De Clermont-Ferrand - Neurologie
      • Nantes, France
        • CHU de Nantes - Hôpital Laennec - Neurology
      • Nîmes, France
        • CHU Nimes - Hôpital Caremeau - Service de Neurologie
      • Paris, France
        • Assistance Publique-Hopitaux de Paris (AP-HP) - Unite de Recherche Clinique Saint-Louis Lariboisere-Ferd Widal
  • Georgia
      • Batumi, Georgia
        • Ltd "Health"
      • Tbilisi, 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
  • Germany
      • Berlin, Germany
        • Charite - Universitaetsmedizin Berlin - Neurology
      • Berlin, Germany
        • FutureMeds Berlin (emovis)
      • Dresden, Germany
        • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden - UniversitaetsSchmerzCentrum - USC
      • Essen, Germany
        • Universitatsklinikum Essen (Aor)
      • Frankfurt, Germany
        • Kopfschmerzzentrum Frankfurt
      • Gera, Germany
        • Praxis Dr. Oehlwein
      • Greifswald, Germany
        • Universitaetsmedizin Greifswald
      • Göppingen, Germany
        • Schmerz- und Palliativzentrum Goeppingen
      • Ulm, Germany
        • NeuroPoint
  • Japan
      • Fukuoka, Japan
        • Ikeda Neurosurgical Clinic - Neurosurgery
      • Hiroshima, Japan
        • DOI Internal Medicine/Neurology Clinic
      • Hyōgo, Japan
        • Konankai Konan Medical Center - Neurology
      • Kagoshima, Japan
        • Tanaka Neurosurgery & Headache Clinic
      • Kyoto, Japan
        • Ishikawa Clinic
      • Miyagi, Japan
        • Sendai Zutsu No-Shinkei Clinic - Neurology
      • Osaka, Japan
        • Tominaga Clinic - Neurology
      • Shizuoka, Japan
        • Japanese Red Cross Shizuoka Hospital - Neurology
      • Tokyo, Japan
        • Iwata Neurosurgery Clinic
      • Tokyo, Japan
        • Kitasato University Kitasato Institute Hospital - Urology - Neurology
      • Yamaguchi, Japan
        • Nagamitsu Clinic - Neurology
  • New Zealand
      • Auckland, New Zealand
        • Optimal Clinical Trials
      • Christchurch, New Zealand
        • New Zealand Brain Research Institute at University of Otago
      • Christchurch, New Zealand
        • Optimal Clinical Trials - Christchurch
      • Christchurch, New Zealand
        • Pacific Clinical Research Network (PCRN) - Christchurch
      • Nelson, New Zealand
        • Pacific Clinical Research Network (PCRN) - Tasman
      • Takapuna, New Zealand
        • Pacific Clinical Research Network (PCRN) - Auckland
      • Upper Hutt, New Zealand
        • Lakeland Clinical Trials Wellington
  • Poland
      • Częstochowa, Poland
        • Synexus Polska Sp. z o.o.
      • Katowice, Poland
        • Silmedic Sp. z o.o.
      • Katowice, Poland
        • Synexus Katowice
      • Katowice, Poland
        • Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
      • Krakow, Poland
        • Centrum Medyczne PROMED
      • Krakow, Poland
        • CM Linden
      • Krakow, Poland
        • FutureMeds Krakow
      • Krakow, Poland
        • Specjalistyczne Gabinety Sp. z o.o.
      • Lodz, Poland
        • FutureMeds Lodz
      • Oświęcim, Poland
        • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
      • Pomorskie, Poland
        • Synexus Polska Sp. z o.o. - Oddzial w Gdyni
      • Puławy, Poland
        • Velocity Nova Sp. z o.o - Velocity Pulawy
      • Siedlce, Poland
        • ETG Siedlce
      • Warsaw, Poland
        • Centrum Leczenia Zaburzen Pamieci i Neuroobrazowania Affidea
      • Warsaw, Poland
        • City Clinic Research Sp. z o.o.
      • Warsaw, Poland
        • ETG Neuroscience Sp. z o.o.
      • Wroclaw, Poland
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
  • South Korea
      • Gyeonggi-do, South Korea
        • Hallym University Dongtan Sacred Heart Hospital - Neurology
      • Gyeonggi-do, South Korea
        • Inje University Ilsan Paik Hospital - Allergology
      • Seoul, South Korea
        • Seoul National University Hospital
      • Seoul, South Korea
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea
        • Ewha Womans University Seoul Hospital - Neurology
      • Seoul, South Korea
        • Kangbuk Samsung Hospital - Neurology
      • Seoul, South Korea
        • Nowon Eulji Medical Center, Eulji University - Neurology
  • Spain
      • Barcelona, Spain
        • Hospital Clinic de Barcelona - Neurología
      • Barcelona, Spain
        • Hospital Universitario Vall d'Hebron - Enfermedades Infecciosas
      • Cadiz, Spain
        • FutureMeds Spain Cádiz
      • Madrid, Spain
        • FutureMeds Madrid
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla - Neurologia
      • Seville, Spain
        • Hospital Universitario Virgen del Rocío
      • Valladolid, Spain
        • Hospital Clinico Universitario de Valladolid - Gastroenterology
  • United Kingdom
      • Exeter, United Kingdom
        • Royal Devon And Exeter Hospital - Neurology
      • Hull, United Kingdom
        • Hull University Teaching Hospitals NHS Trust - Hull Royal Infirmary
      • Liverpool, United Kingdom
        • Walton Centre For Neurology And Neurosurgery
      • London, United Kingdom
        • King's College Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates
      • Huntsville, Alabama, United States, 35801
        • Rehabilitation & Neurological Services, LLC
    • Arizona
      • Chandler, Arizona, United States, 85286
        • MD First Research - Chandler
      • Chandler, Arizona, United States, 85224
        • MD First Research - Chandler - Neurology
    • California
      • Apple Valley, California, United States, 92308
        • Axiom Research, LLC
      • Carlsbad, California, United States, 92011
        • Profound Research. LLC - NCSC
      • Encino, California, United States, 91316
        • WR-PRI Encino
      • Encino, California, United States, 91316
        • M3Wake -PRI Encino
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
      • Fullerton, California, United States, 92832
        • Fullerton Neurological Center - Neurology
      • Fullerton, California, United States, 92832
        • Neurology Center of North Orange County
      • La Jolla, California, United States, 92037
        • Kaizen Brain Center
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute (PRI)
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute (PRI) - Los Alamitos/Long Beach
      • Pasadena, California, United States, 91105
        • Profound Research, LLC
      • San Diego, California, United States, 92101
        • Acclaim Clinical Research - Internal Medicine
      • Thousand Oaks, California, United States, 91360
        • Clinical Trials Management LLC
      • West Hills, California, United States, 91307
        • Alliance Clinical West Hills (Focus Clinical Research)
    • Colorado
      • Fort Collins, Colorado, United States, 80501
        • Advanced Neuroscience Research Center, LLC
      • Fort Collins, Colorado, United States, 80524
        • Advanced Neuroscience Research Center, LLC - Neurology
    • Connecticut
      • Stamford, Connecticut, United States, 06901
        • New England Institute for Neurology and Headache (NEINH)/Medical Practice
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Neurology Offices
      • Hialeah, Florida, United States, 33012
        • AGA Clinical Trials
      • Lake City, Florida, United States, 32055
        • M3 Wake Research/MSRA,LLC
      • Lake City, Florida, United States, 32055
        • M3 Wake Research/MSRA, LLC
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Pensacola, Florida, United States, 32502
        • Emerald Coast Center For Neurological Disorders
      • Winter Park, Florida, United States, 32789
        • Conquest Research
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • NeuroTrials Research, Inc.
    • Louisiana
      • Chalmette, Louisiana, United States, 70043
        • Crescent City Headache and Neurology Center, LLC
      • Covington, Louisiana, United States, 70433
        • Ochsner Health Center - Covington
      • New Orleans, Louisiana, United States, 70112
        • DelRicht Research
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research at Touro Medical Center
      • New Orleans, Louisiana, United States, 70115
        • LSU Healthcare Network Orthopedic & Sports Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Medstar Franklin Square Medical Center
      • Baltimore, Maryland, United States, 21218
        • MedStar Neurosciences and Rehabilitation Research Network
      • Baltimore, Maryland, United States, 21218
        • MedStar Neurosciences and Rehabilitation
      • Baltimore, Maryland, United States, 21237
        • MedStar Franklin Square Hospital Center
    • Massachusetts
      • Foxborough, Massachusetts, United States, 02035
        • Neurology Center of NE,PC - Neurology
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research
      • Westborough, Massachusetts, United States, 01581
        • Mass Institute of Clinical Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain & Neurological Institute
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain & Neurological Institute - Neurology/Pain
      • Grand Blanc, Michigan, United States, 48439
        • Michigan Center of Medical Research
    • Minnesota
      • Burnsville, Minnesota, United States, 55306
        • Minneapolis Clinic-Neurology
    • Nebraska
      • Papillion, Nebraska, United States, 68046
        • Papillion Research Center/Avacare
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Alliance Clinical Las Vegas (Excel Clinical Research) - Internal Medicine
    • New York
      • Brooklyn, New York, United States, 11229
        • Integrative Clinical Trials, LLC
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center: Headache Center
      • Williamsville, New York, United States, 14221
        • Upstate Clinical Research Associates
      • Williamsville, New York, United States, 14221
        • Upstate Clinical Research Associates - Research Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • UC Gardner Neuroscience Institute
      • Dayton, Ohio, United States, 45459
        • Neurology Diagnostics, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians - Curry Hollow
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc - Memphis
    • Texas
      • Dallas, Texas, United States, 75201
        • Zenos Clinical Research - Internal Medicine
      • Frisco, Texas, United States, 75034
        • Lone Star Neurology
      • Houston, Texas, United States, 77002
        • Elevate Clinical Research - Houston
      • Houston, Texas, United States, 77002
        • Javara Inc. - Houston, TX
      • New Caney, Texas, United States, 77357
        • Javara Inc. - New Caney, TX
    • Utah
      • Salt Lake City, Utah, United States, 84101
        • J. Lewis Research-Site Number:8400053
      • West Valley City, Utah, United States, 84119
        • ChronicleBio
    • Washington
      • Tacoma, Washington, United States, 98409
        • Puget Sound Neurology - Neurology
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Marshall Health Clinical Research Center
      • Kingwood, West Virginia, United States, 26537
        • Frontier Clinical Research, LLC - Kingwood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Step 1 - Cohort 1 - Placebo
Participants will receive placebo through injections at Day 1.
Other: Placebo
Excipients without active substance, Lyophilised powder
Placebo Comparator: Step 1 - Cohort 2 - Placebo
Participants will receive placebo through injections at Day 1.
Other: Placebo
Excipients without active substance, Lyophilised powder
Placebo Comparator: Step 2- EM group placebo
Placebo will be administered to the participants in a single treatment cycle
Other: Placebo
Excipients without active substance, Lyophilised powder
Placebo Comparator: Step 2- CM group placebo
Placebo will be administered to the participants in a single treatment cycle
Other: Placebo
Excipients without active substance, Lyophilised powder
Experimental: Step 1 - Cohort 1- Corabotase
Participants will receive Corabotase dose A through injections at Day 1.
Biological: Corabotase
Lyophilised powder
Experimental: Step 1 - Cohort 2 - Corabotase
Participants will receive Corabotase dose B through injections at Day 1.
Biological: Corabotase
Lyophilised powder
Experimental: Step 2- EM group Corabotase Dose A
Dose A will be administered to the participants in a single treatment cycle.
Biological: Corabotase dose A
Lyophilised powder
Experimental: Step 2- EM group Corabotase Dose B
Dose B will be administered to the participants in a single treatment cycle
Biological: Corabotase dose B
Lyophilised powder
Experimental: Step 2- CM group Corabotase Dose A
Dose A will be administered to the participants in a single treatment cycle
Biological: Corabotase dose A
Lyophilised powder
Experimental: Step 2- CM group Corabotase Dose B
Dose B will be administered to the participants in a single treatment cycle
Biological: Corabotase dose B
Lyophilised powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants experiencing any Adverse Event (AEs) including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse event of special interest (AESI) and AE leading to treatment discontinuation
Time Frame: For step 1: From baseline until end of study at Week 36
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.
For step 1: From baseline until end of study at Week 36
Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters
Time Frame: For step 1: At all timepoints post injection until Week 36
Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator.
For step 1: At all timepoints post injection until Week 36
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Time Frame: For step 1: At all timepoints post injection until Week 36
Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
For step 1: At all timepoints post injection until Week 36
Percentage of participants with clinically significant change from baseline in facial examination
Time Frame: For step 1: At all timepoints post injection until Week 36
Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.
For step 1: At all timepoints post injection until Week 36
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings
Time Frame: For step 1: At all timepoints post injection until Week 36
For step 1: At all timepoints post injection until Week 36
Treatment-emergence of suicidal ideation/suicidal behaviour
Time Frame: For step 1: At all timepoints post injection until Week 36

It will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire that consists of 2 subscales:

  1. Ideation severity subscale: questions answered yes/no, severity of ideation scored 1-5 with 5 being most severe
  2. Intensity of ideation subscale : scores range from 2-25 with higher scores indicating more severe intensity of ideation.
For step 1: At all timepoints post injection until Week 36
Percentage of participants with Binding antibodies to IPN10200
Time Frame: For step 1: At baseline, Week 4, Week 12 and Week 36.
For step 1: At baseline, Week 4, Week 12 and Week 36.
Percentage of participants with neutralising antibodies to IPN10200
Time Frame: For step 1: At baseline, Week 4, Week 12 and Week 36.
For step 1: At baseline, Week 4, Week 12 and Week 36.
Change from baseline in the number of Monthly migraine days (MMD)s
Time Frame: For step 2: At Week 12 (Weeks 9-12).
For step 2: At Week 12 (Weeks 9-12).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the number of MMD
Time Frame: For Step 1 and step 2: From Week 1 to Week 36.
For Step 1 and step 2: From Week 1 to Week 36.
Change from baseline in the number of Monthly Headache Days (MHD)
Time Frame: For Step 1 and step 2: From Week 1 to Week 36
For Step 1 and step 2: From Week 1 to Week 36
Change from baseline in the number of moderate/severe MHD
Time Frame: For Step 1 and step 2: From Week 1 to Week 36
For Step 1 and step 2: From Week 1 to Week 36
Migraine prevention response
Time Frame: For Step 1 and step 2: From Week 1 to Week 36
Migraine prevention response is assessed using two thresholds: by a reduction from baseline of either ≥50% or ≥75% in MMD
For Step 1 and step 2: From Week 1 to Week 36
Headache prevention response
Time Frame: For Step 1 and step 2: From Week 1 to Week 36.
Assessed using two thresholds: by a reduction from baseline of either ≥50% or ≥ 75% in MHD
For Step 1 and step 2: From Week 1 to Week 36.
Change from baseline in the number of days per 4 week period of acute medication use for migraine relief.
Time Frame: For Step 1 and step 2: From Week 1 to Week 36.
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.
For Step 1 and step 2: From Week 1 to Week 36.
The use of acute migraine medication (yes or no)
Time Frame: For Step 1 and step 2: From Week 1 to Week 36.
The use of acute migraine medication will be recorded in the daily eDiary.
For Step 1 and step 2: From Week 1 to Week 36.
Percentage of participants with Binding antibodies to IPN10200
Time Frame: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.
For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.
Percentage of participants with neutralising antibodies to IPN10200
Time Frame: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.
For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Investigators

  • Study Director: Ipsen Medical Director, Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-10200-454
  • 2024-511101-28-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

IPD Sharing Time Frame

Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.

IPD Sharing Access Criteria

Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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