AzTrials
AzTrials

Episodic MigrainePhase 2MERANTINCT06625060

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

A Phase 2 study testing Corabotase, Corabotase dose A and Corabotase dose B in people with Episodic Migraine and Chronic Migraine, run by Ipsen at 162 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Episodic Migraine, Chronic Migraine
What is being tested?
Corabotase, Corabotase dose A and Corabotase dose B
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
670 participants
Where
162 sitesin 14 countries
Study dates
10 Oct 2024to 31 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • Male or female ≥18 to 80 years of age at the time of signing the informed consent;
  • Diagnosis of either EM or CM, per ICHD-3 criteria, for at least 12 months prior to the screening visit;
  • Diagnosis of migraine at ≤50 years of age;
  • 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;
  • 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;
  • Participant with a history of use of at least one preventive treatment for migraine.

Who cannot join

  • 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 (MOH);
  • Current uncontrolled psychiatric or psychological condition, or one that could confound assessment of headaches/migraines or interfere with study participation;
  • 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.
  • 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.
Show all 28Show fewer
  • Clinically relevant skin condition or infection that could interfere with injection of study intervention;
  • Participant has any medical condition or situation that would make them unsuitable for participation in the study;
  • Participant receiving more than one allowable concomitant migraine preventive treatment;
  • 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);
  • 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.
  • Concurrent participation in another interventional clinical study (or within specified timeframe according to national or local legislation or requirements);
  • 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;
  • 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;
  • 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;
  • History of alcohol or drug abuse within 5 years of the screening visit (excluding medication overuse for headache);
  • Body mass index (BMI) ≥35 kg/m² at the screening visit;
  • Known clinically significant hypersensitivity to any of the study drugs, excipients or materials used to administer the study drug;
  • Patients who, in the clinician's judgment, are actively suicidal, and therefore, deemed to be at significant risk for suicide.
  • 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.

Trial locations and contacts

162 sites in 14 countries.

162 sites in 14 countries

United States68 sites

  • Michigan Head Pain & Neurological Institute - Neurology/Pain

    Ann Arbor, Michigan, 48104

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

  • Axiom Research, LLC

    Apple Valley, California, 92308

  • NeuroTrials Research, Inc.

    Atlanta, Georgia, 30309

  • MedStar Neurosciences and Rehabilitation Research Network

    Baltimore, Maryland, 21218

  • MedStar Neurosciences and Rehabilitation

    Baltimore, Maryland, 21218

  • MedStar Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Medstar Franklin Square Medical Center

    Baltimore, Maryland, 21237

  • Central Research Associates

    Birmingham, Alabama, 35205

  • Neurology Offices

    Boca Raton, Florida, 33432

  • Integrative Clinical Trials, LLC

    Brooklyn, New York, 11229

  • Minneapolis Clinic-Neurology

    Burnsville, Minnesota, 55306

  • Profound Research. LLC - NCSC

    Carlsbad, California, 92011

  • Crescent City Headache and Neurology Center, LLC

    Chalmette, Louisiana, 70043

  • MD First Research - Chandler - Neurology

    Chandler, Arizona, 85224

  • MD First Research - Chandler

    Chandler, Arizona, 85286

  • UC Gardner Neuroscience Institute

    Cincinnati, Ohio, 45219

  • Ochsner Health Center - Covington

    Covington, Louisiana, 70433

  • Zenos Clinical Research - Internal Medicine

    Dallas, Texas, 75201

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459

  • M3Wake -PRI Encino

    Encino, California, 91316

  • WR-PRI Encino

    Encino, California, 91316

  • Advanced Neuroscience Research Center, LLC

    Fort Collins, Colorado, 80501

  • Advanced Neuroscience Research Center, LLC - Neurology

    Fort Collins, Colorado, 80524

  • Neurology Center of NE,PC - Neurology

    Foxborough, Massachusetts, 02035

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Lone Star Neurology

    Frisco, Texas, 75034

  • Fullerton Neurological Center - Neurology

    Fullerton, California, 92832

  • Neurology Center of North Orange County

    Fullerton, California, 92832

  • Michigan Center of Medical Research

    Grand Blanc, Michigan, 48439

  • AGA Clinical Trials

    Hialeah, Florida, 33012

  • Elevate Clinical Research - Houston

    Houston, Texas, 77002

  • Javara Inc. - Houston, TX

    Houston, Texas, 77002

  • Marshall Health Clinical Research Center

    Huntington, West Virginia, 25701

  • Rehabilitation & Neurological Services, LLC

    Huntsville, Alabama, 35801

  • Frontier Clinical Research, LLC - Kingwood

    Kingwood, West Virginia, 26537

  • Kaizen Brain Center

    La Jolla, California, 92037

  • M3 Wake Research/MSRA, LLC

    Lake City, Florida, 32055

  • M3 Wake Research/MSRA,LLC

    Lake City, Florida, 32055

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

    Las Vegas, Nevada, 89101

  • Pharmacology Research Institute (PRI)

    Los Alamitos, California, 90720

  • Clinical Neuroscience Solutions, Inc - Memphis

    Memphis, Tennessee, 38119

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Javara Inc. - New Caney, TX

    New Caney, Texas, 77357

  • DelRicht Research

    New Orleans, Louisiana, 70112

  • DelRicht Research at Touro Medical Center

    New Orleans, Louisiana, 70115

  • LSU Healthcare Network Orthopedic & Sports Medicine

    New Orleans, Louisiana, 70115

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

    Newport Beach, California, 92660

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Papillion Research Center/Avacare

    Papillion, Nebraska, 68046

  • Profound Research, LLC

    Pasadena, California, 91105

  • Emerald Coast Center For Neurological Disorders

    Pensacola, Florida, 32502

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Preferred Primary Care Physicians - Curry Hollow

    Pittsburgh, Pennsylvania, 15236

  • J. Lewis Research-Site Number:8400053

    Salt Lake City, Utah, 84101

  • Acclaim Clinical Research - Internal Medicine

    San Diego, California, 92101

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

    Stamford, Connecticut, 06901

  • Puget Sound Neurology - Neurology

    Tacoma, Washington, 98409

  • Montefiore Medical Center: Headache Center

    The Bronx, New York, 10461

  • Clinical Trials Management LLC

    Thousand Oaks, California, 91360

  • MedVadis Research

    Waltham, Massachusetts, 02451

  • Alliance Clinical West Hills (Focus Clinical Research)

    West Hills, California, 91307

  • ChronicleBio

    West Valley City, Utah, 84119

  • Mass Institute of Clinical Research

    Westborough, Massachusetts, 01581

  • Upstate Clinical Research Associates - Research Center

    Williamsville, New York, 14221

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

Poland17 sites

  • Synexus Polska Sp. z o.o.

    Częstochowa

  • Silmedic sp. z o.o.

    Katowice

  • Synexus Katowice

    Katowice

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

    Katowice

  • Centrum Medyczne PROMED

    Krakow

  • CM Linden

    Krakow

  • FutureMeds Krakow

    Krakow

  • Specjalistyczne Gabinety Sp. z o.o.

    Krakow

  • FutureMeds Lodz

    Lodz

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

    Oświęcim

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

    Pomorskie

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

    Puławy

  • ETG Siedlce

    Siedlce

  • Centrum Leczenia Zaburzen Pamieci i Neuroobrazowania Affidea

    Warsaw

  • City Clinic Research Sp. z o.o.

    Warsaw

  • ETG Neuroscience Sp. z o.o.

    Warsaw

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw

Other trials in Poland

Japan11 sites

  • Ikeda Neurosurgical Clinic - Neurosurgery

    Fukuoka

  • DOI Internal Medicine/Neurology Clinic

    Hiroshima

  • Konankai Konan Medical Center - Neurology

    Hyōgo

  • Tanaka Neurosurgery & Headache Clinic

    Kagoshima

  • Ishikawa Clinic

    Kyoto

  • Sendai Zutsu No-Shinkei Clinic - Neurology

    Miyagi

  • Tominaga Clinic - Neurology

    Osaka

  • Japanese Red Cross Shizuoka Hospital - Neurology

    Shizuoka

  • Iwata Neurosurgery Clinic

    Tokyo

  • Kitasato University Kitasato Institute Hospital - Urology - Neurology

    Tokyo

  • Nagamitsu Clinic - Neurology

    Yamaguchi

Other trials in Japan

Germany9 sites

  • Charite - Universitaetsmedizin Berlin - Neurology

    Berlin

  • FutureMeds Berlin (emovis)

    Berlin

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

    Dresden

  • Universitätsklinikum Essen (AöR)

    Essen

  • Kopfschmerzzentrum Frankfurt

    Frankfurt

  • Praxis Dr. Oehlwein

    Gera

  • Schmerz- und Palliativzentrum Goeppingen

    Göppingen

  • Universitaetsmedizin Greifswald

    Greifswald

  • NeuroPoint

    Ulm

Other trials in Germany

Czechia7 sites

  • Pratia Brno s.r.o.

    Brno

  • NEUROHK s.r.o.

    Choceň

  • NeuropsychiatrieHK, s.r.o.

    Hradec Králové

  • Fakultni nemocnice Ostrava - Neurologicka klinika

    Ostrava

  • Pratia Pardubice a.s.

    Pardubice

  • AXON clinical

    Prague

  • DADO MEDICAL s.r.o.

    Prague

Other trials in Czechia

New Zealand7 sites

  • Optimal Clinical Trials

    Auckland

  • New Zealand Brain Research Institute at University of Otago

    Christchurch

  • Optimal Clinical Trials - Christchurch

    Christchurch

  • Pacific Clinical Research Network (PCRN) - Christchurch

    Christchurch

  • Pacific Clinical Research Network (PCRN) - Tasman

    Nelson

  • Pacific Clinical Research Network (PCRN) - Auckland

    Takapuna

  • Lakeland Clinical Trials Wellington

    Upper Hutt

Other trials in New Zealand

South Korea7 sites

  • Hallym University Dongtan Sacred Heart Hospital - Neurology

    Gyeonggi-do

  • Inje University Ilsan Paik Hospital - Allergology

    Gyeonggi-do

  • Ewha Womans University Seoul Hospital - Neurology

    Seoul

  • Kangbuk Samsung Hospital - Neurology

    Seoul

  • Nowon Eulji Medical Center, Eulji University - Neurology

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

Other trials in South Korea

Spain7 sites

  • Hospital Clinic de Barcelona - Neurología

    Barcelona

  • Hospital Universitario Vall d'Hebron - Enfermedades Infecciosas

    Barcelona

  • FutureMeds Spain Cádiz

    Cadiz

  • FutureMeds Madrid

    Madrid

  • Hospital Universitario Marqués de Valdecilla - Neurologia

    Santander

  • Hospital Universitario Virgen del Rocio

    Seville

  • Hospital Clinico Universitario de Valladolid - Gastroenterology

    Valladolid

Other trials in Spain

Canada6 sites

  • CaRe Clinic - Calgary

    Calgary

  • University of Calgary Foothills Campus

    Calgary

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

    Lévis

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

    Québec

  • CaRe Clinic Red Deer

    Red Deer

  • Bluewater Clinical Research Group Inc.

    Sarnia

Other trials in Canada

Georgia6 sites

  • Ltd "Health"

    Batumi

  • "Pineo Medical Ecosystem" LTD

    Tbilisi

  • LTD "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi

  • LTD "Multiprofile Clinic Consilium Medulla"

    Tbilisi

  • LTD New Hospitals - Neurology

    Tbilisi

  • Ltd. S.Khechinashvili University Clinic

    Tbilisi

Other trials in Georgia

Brazil5 sites

  • Instituto de Neurologia de Curitiba

    Paraná

  • Associação Hospitalar Moinhos de Vento

    Rio Grande

  • A2Z Clinical

    São Paulo

  • Hospital Alemao Oswaldo Cruz

    São Paulo

  • Pseg Centro de Pesquisa Clínica S.A

    São Paulo

Other trials in Brazil

France5 sites

  • CHU Amiens Sud-Centre Rech Clinique

    Amiens

  • Centre Hospitalier Regional Universtaire De Clermont-Ferrand - Neurologie

    Clermont-Ferrand

  • CHU de Nantes - Hôpital Laennec - Neurology

    Nantes

  • CHU Nimes - Hôpital Caremeau - Service de Neurologie

    Nîmes

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

    Paris

Other trials in France

United Kingdom4 sites

  • Royal Devon And Exeter Hospital - Neurology

    Exeter

  • Hull University Teaching Hospitals NHS Trust - Hull Royal Infirmary

    Hull

  • Walton Centre For Neurology And Neurosurgery

    Liverpool

  • King's College Hospital

    London

Other trials in United Kingdom

Australia3 sites

  • The Alfred Hospital - Neurology

    Melbourne

  • Western Health - Neurology & Stroke Services

    Saint Albans

  • The Royal Melbourne Hospital - Neurology

    Victoria Park

Other trials in Australia

About this study

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

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.

Read more

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.

Read the 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).
Being tested
Corabotase, Placebo, Corabotase dose A, Corabotase dose B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CorabotaseBiological

    Lyophilised powder

  • PlaceboOther

    Excipients without active substance, Lyophilised powder

  • Corabotase dose ABiological

    Lyophilised powder

  • Corabotase dose BBiological

    Lyophilised powder

Study groups in NCT06625060
Study groupRoleWhat they receive
Step 1 - Cohort 1- CorabotaseExperimentalParticipants will receive Corabotase dose A through injections at Day 1.
Receives: Biological: Corabotase
Step 1 - Cohort 1 - PlaceboPlacebo comparatorParticipants will receive placebo through injections at Day 1.
Receives: Other: Placebo
Step 1 - Cohort 2 - CorabotaseExperimentalParticipants will receive Corabotase dose B through injections at Day 1.
Receives: Biological: Corabotase
Step 1 - Cohort 2 - PlaceboPlacebo comparatorParticipants will receive placebo through injections at Day 1.
Receives: Other: Placebo
Step 2- EM group Corabotase Dose AExperimentalDose A will be administered to the participants in a single treatment cycle.
Receives: Biological: Corabotase dose A
Step 2- EM group Corabotase Dose BExperimentalDose B will be administered to the participants in a single treatment cycle
Receives: Biological: Corabotase dose B
Step 2- EM group placeboPlacebo comparatorPlacebo will be administered to the participants in a single treatment cycle
Receives: Other: Placebo
Step 2- CM group Corabotase Dose AExperimentalDose A will be administered to the participants in a single treatment cycle
Receives: Biological: Corabotase dose A
Step 2- CM group Corabotase Dose BExperimentalDose B will be administered to the participants in a single treatment cycle
Receives: Biological: Corabotase dose B
Step 2- CM group placeboPlacebo comparatorPlacebo will be administered to the participants in a single treatment cycle
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: For step 1: From baseline until end of study at Week 36

  2. Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters

    Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator.

    Measured: For step 1: At all timepoints post injection until Week 36

  3. Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs

    Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.

    Measured: For step 1: At all timepoints post injection until Week 36

  4. Percentage of participants with clinically significant change from baseline in facial examination

    Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.

    Measured: For step 1: At all timepoints post injection until Week 36

  5. Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings

    Measured: For step 1: At all timepoints post injection until Week 36

  6. Treatment-emergence of suicidal ideation/suicidal behaviour

    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.

    Measured: For step 1: At all timepoints post injection until Week 36

  7. Percentage of participants with Binding antibodies to IPN10200

    Measured: For step 1: At baseline, Week 4, Week 12 and Week 36.

  8. Percentage of participants with neutralising antibodies to IPN10200

    Measured: For step 1: At baseline, Week 4, Week 12 and Week 36.

  9. Change from baseline in the number of Monthly migraine days (MMD)s

    Measured: For step 2: At Week 12 (Weeks 9-12).

Secondary outcomes (9)

  1. Change from baseline in the number of MMD

    Measured: For Step 1 and step 2: From Week 1 to Week 36.

  2. Change from baseline in the number of Monthly Headache Days (MHD)

    Measured: For Step 1 and step 2: From Week 1 to Week 36

  3. Change from baseline in the number of moderate/severe MHD

    Measured: For Step 1 and step 2: From Week 1 to Week 36

  4. Migraine prevention response

    Migraine prevention response is assessed using two thresholds: by a reduction from baseline of either ≥50% or ≥75% in MMD

    Measured: For Step 1 and step 2: From Week 1 to Week 36

  5. Headache prevention response

    Assessed using two thresholds: by a reduction from baseline of either ≥50% or ≥ 75% in MHD

    Measured: For Step 1 and step 2: From Week 1 to Week 36.

  6. Change from baseline in the number of days per 4 week period of acute medication use for migraine relief.

    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.

    Measured: For Step 1 and step 2: From Week 1 to Week 36.

  7. The use of acute migraine medication (yes or no)

    The use of acute migraine medication will be recorded in the daily eDiary.

    Measured: For Step 1 and step 2: From Week 1 to Week 36.

  8. Percentage of participants with Binding antibodies to IPN10200

    Measured: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.

  9. Percentage of participants with neutralising antibodies to IPN10200

    Measured: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2024
  2. Study start10 Oct 2024
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Model Description
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
670 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06625060
Sponsor's protocol ID
CLIN-10200-454
Other IDs
2024-511101-28-00
Acronym
MERANTI
Status last verified
Sep 2026
First submitted
1 Oct 2024
Last updated
8 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Corabotase, Corabotase dose A and Corabotase dose B in people with Episodic Migraine and Chronic Migraine, run by Ipsen at 162 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in United States, Poland, Japan, Germany, Czechia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06625060.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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