A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults
MERANTI
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
2 other identifiers
interventional
641
14 countries
166
Brief 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. 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 IPN10200 directly into the muscles of the head and neck to prevent EM and CM,
- The right amount (dose) of IPN10200 to inject at each point,
- The total amount (dose) of IPN10200 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2024
Typical duration for phase_2
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2024
CompletedFirst Posted
Study publicly available on registry
October 3, 2024
CompletedStudy Start
First participant enrolled
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
May 5, 2026
April 1, 2026
2.3 years
October 1, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (9)
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.
For step 1: From baseline until end of study at Week 36
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.
For step 1: At all timepoints post injection until Week 36
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.
For step 1: At all timepoints post injection until Week 36
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.
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
For step 1: At all timepoints post injection until Week 36
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.
For step 1: At all timepoints post injection until Week 36
Percentage of participants with Binding antibodies to IPN10200
For step 1: At baseline, Week 4, Week 12 and Week 36.
Percentage of participants with neutralising antibodies to IPN10200
For step 1: At baseline, Week 4, Week 12 and Week 36.
Change from baseline in the number of Monthly migraine days (MMD)s
For step 2: At Week 12 (Weeks 9-12).
Secondary Outcomes (9)
Change from baseline in the number of MMD
For Step 1 and step 2: From Week 1 to Week 36.
Change from baseline in the number of Monthly Headache Days (MHD)
For Step 1 and step 2: From Week 1 to Week 36
Change from baseline in the number of moderate/severe MHD
For Step 1 and step 2: From Week 1 to Week 36
Migraine prevention response
For Step 1 and step 2: From Week 1 to Week 36
Headache prevention response
For Step 1 and step 2: From Week 1 to Week 36.
- +4 more secondary outcomes
Study Arms (10)
Step 1 - Cohort 1- IPN10200
EXPERIMENTALParticipants will receive IPN10200 dose A through injections at Day 1.
Step 1 - Cohort 1 - Placebo
PLACEBO COMPARATORParticipants will receive placebo through injections at Day 1.
Step 1 - Cohort 2 - IPN10200
EXPERIMENTALParticipants will receive IPN10200 dose B through injections at Day 1.
Step 1 - Cohort 2 - Placebo
PLACEBO COMPARATORParticipants will receive placebo through injections at Day 1.
Step 2- EM group IPN10200 Dose A
EXPERIMENTALDose A will be administered to the participants in a single treatment cycle.
Step 2- EM group IPN10200 Dose B
EXPERIMENTALDose B will be administered to the participants in a single treatment cycle
Step 2- EM group placebo
PLACEBO COMPARATORPlacebo will be administered to the participants in a single treatment cycle
Step 2- CM group IPN10200 Dose A
EXPERIMENTALDose A will be administered to the participants in a single treatment cycle
Step 2- CM group IPN10200 Dose B
EXPERIMENTALDose B will be administered to the participants in a single treatment cycle
Step 2- CM group placebo
PLACEBO COMPARATORPlacebo will be administered to the participants in a single treatment cycle
Interventions
Excipients without active substance, Lyophilised powder
Lyophilised powder
Lyophilised powder
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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;
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (166)
Central Research Associates
Birmingham, Alabama, 35205, United States
Rehabilitation & Neurological Services, LLC
Huntsville, Alabama, 35801, United States
MD First Research - Chandler - Neurology
Chandler, Arizona, 85224, United States
MD First Research - Chandler
Chandler, Arizona, 85286, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Axiom Research, LLC
Apple Valley, California, 92308, United States
Profound Research. LLC - NCSC
Carlsbad, California, 92011, United States
M3Wake -PRI Encino
Encino, California, 91316, United States
WR-PRI Encino
Encino, California, 91316, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Fullerton Neurological Center - Neurology
Fullerton, California, 92832, United States
Neurology Center of North Orange County
Fullerton, California, 92832, United States
University of California, Irvine - Department of Neurology
Irvine, California, 92697, United States
Kaizen Brain Center
La Jolla, California, 92037, 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
Profound Research, LLC
Pasadena, California, 91105, United States
Acclaim Clinical Research - Internal Medicine
San Diego, California, 92101, United States
Clinical Trials Management LLC
Thousand Oaks, California, 91360, United States
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California, 91307, 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
New England Institute for Neurology and Headache (NEINH)/Medical Practice
Stamford, Connecticut, 06901, United States
Neurology Offices
Boca Raton, Florida, 33432, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
M3 Wake Research/MSRA, LLC
Lake City, Florida, 32055, United States
M3 Wake Research/MSRA,LLC
Lake City, Florida, 32055, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Emerald Coast Center For Neurological Disorders
Pensacola, Florida, 32502, United States
Conquest Research
Winter Park, Florida, 32789, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, 30309, United States
Crescent City Headache and Neurology Center, LLC
Chalmette, Louisiana, 70043, United States
Ochsner Health Center - Covington
Covington, Louisiana, 70433, United States
DelRicht Research
New Orleans, Louisiana, 70112, United States
DelRicht Research at Touro Medical Center
New Orleans, Louisiana, 70115, United States
LSU Healthcare Network Orthopedic & Sports Medicine
New Orleans, Louisiana, 70115, United States
MedStar Neurosciences and Rehabilitation Research Network
Baltimore, Maryland, 21218, United States
MedStar Neurosciences and Rehabilitation
Baltimore, Maryland, 21218, United States
MedStar Franklin Square Hospital Center
Baltimore, Maryland, 21237, United States
Medstar Franklin Square Medical Center
Baltimore, Maryland, 21237, United States
Neurology Center of NE,PC - Neurology
Foxborough, Massachusetts, 02035, United States
MedVadis Research
Waltham, Massachusetts, 02451, United States
Mass Institute of Clinical Research
Westborough, Massachusetts, 01581, United States
Michigan Head Pain & Neurological Institute - Neurology/Pain
Ann Arbor, Michigan, 48104, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Michigan Center of Medical Research
Grand Blanc, Michigan, 48439, United States
Minneapolis Clinic-Neurology
Burnsville, Minnesota, 55306, United States
Papillion Research Center/Avacare
Papillion, Nebraska, 68046, United States
Alliance Clinical Las Vegas (Excel Clinical Research) - Internal Medicine
Las Vegas, Nevada, 89101, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229, United States
Montefiore Medical Center: Headache Center
The Bronx, New York, 10461, United States
Upstate Clinical Research Associates - Research Center
Williamsville, New York, 14221, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
UC Gardner Neuroscience Institute
Cincinnati, Ohio, 45219, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, 45459, United States
Mount Carmel Health Systems
New Albany, Ohio, 43054, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Preferred Primary Care Physicians - Curry Hollow
Pittsburgh, Pennsylvania, 15236, United States
Clinical Neuroscience Solutions, Inc - Memphis
Memphis, Tennessee, 38119, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Zenos Clinical Research - Internal Medicine
Dallas, Texas, 75201, United States
Lone Star Neurology
Frisco, Texas, 75034, United States
Elevate Clinical Research - Houston
Houston, Texas, 77002, United States
Javara Inc. - Houston, TX
Houston, Texas, 77002, United States
Javara Inc. - New Caney, TX
New Caney, Texas, 77357, United States
J. Lewis Research-Site Number:8400053
Salt Lake City, Utah, 84101, United States
ChronicleBio
West Valley City, Utah, 84119, United States
Puget Sound Neurology - Neurology
Tacoma, Washington, 98409, United States
Marshall Health Clinical Research Center
Huntington, West Virginia, 25701, United States
Frontier Clinical Research, LLC - Kingwood
Kingwood, West Virginia, 26537, 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 - Hôpital 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
Charite - Universitaetsmedizin Berlin - Neurology
Berlin, Germany
FutureMeds Berlin (emovis)
Berlin, Germany
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden - UniversitaetsSchmerzCentrum - USC
Dresden, Germany
Universitätsklinikum Essen (AöR)
Essen, Germany
Kopfschmerzzentrum Frankfurt
Frankfurt, Germany
Praxis Dr. Oehlwein
Gera, Germany
Schmerz- und Palliativzentrum Goeppingen
Göppingen, Germany
Universitaetsmedizin Greifswald
Greifswald, Germany
Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
Kiel, Germany
NeuroPoint
Ulm, Germany
Ikeda Neurosurgical Clinic - Neurosurgery
Fukuoka, Japan
DOI Internal Medicine/Neurology Clinic
Hiroshima, Japan
Konankai Konan Medical Center - Neurology
Hyōgo, Japan
Tanaka Neurosurgery & Headache Clinic
Kagoshima, Japan
Ishikawa Clinic
Kyoto, Japan
Sendai Zutsu No-Shinkei Clinic - Neurology
Miyagi, Japan
Tominaga Clinic - Neurology
Osaka, Japan
Japanese Red Cross Shizuoka Hospital - Neurology
Shizuoka, Japan
Iwata Neurosurgery Clinic
Tokyo, Japan
Kitasato University Kitasato Institute Hospital - Urology - Neurology
Tokyo, Japan
Nagamitsu Clinic - Neurology
Yamaguchi, Japan
Optimal Clinical Trials
Auckland, 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
Christchurch, New Zealand
Pacific Clinical Research Network (PCRN) - Tasman
Nelson, New Zealand
Pacific Clinical Research Network (PCRN) - Auckland
Takapuna, New Zealand
Lakeland Clinical Trials Wellington
Upper Hutt, New Zealand
Synexus Polska Sp. z o.o.
Częstochowa, Poland
Silmedic sp. z o.o.
Katowice, Poland
Synexus Katowice
Katowice, Poland
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland
Centrum Medyczne PROMED
Krakow, Poland
CM Linden
Krakow, Poland
FutureMeds Krakow
Krakow, Poland
Specjalistyczne Gabinety Sp. z o.o.
Krakow, Poland
FutureMeds Lodz
Lodz, Poland
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Oświęcim, Poland
Synexus Polska Sp. z o.o. - Oddzial w Gdyni
Pomorskie, Poland
Velocity Nova Sp. z o.o - Velocity Pulawy
Puławy, Poland
ETG Siedlce
Siedlce, 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.
Warsaw, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Poland
Hallym University Dongtan Sacred Heart Hospital - Neurology
Gyeonggi-do, South Korea
Inje University Ilsan Paik Hospital - Allergology
Gyeonggi-do, 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
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Hospital Clinic de Barcelona - Neurología
Barcelona, Spain
Hospital Universitario Vall d'Hebron - Enfermedades Infecciosas
Barcelona, Spain
FutureMeds Spain Cádiz
Cadiz, Spain
FutureMeds Madrid
Madrid, Spain
Hospital Universitario Marqués de Valdecilla - Neurologia
Santander, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Clinico Universitario de Valladolid - Gastroenterology
Valladolid, Spain
Royal Devon And Exeter Hospital - Neurology
Exeter, United Kingdom
Hull University Teaching Hospitals NHS Trust - Hull Royal Infirmary
Hull, United Kingdom
Walton Centre For Neurology And Neurosurgery
Liverpool, United Kingdom
King's College Hospital
London, United Kingdom
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Masking Description
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2024
First Posted
October 3, 2024
Study Start
October 10, 2024
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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/).
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.