A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults
NCT ID: NCT06625060
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
641 participants
INTERVENTIONAL
2024-10-10
2027-06-15
Brief Summary
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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.
Detailed Description
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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 IPN10200, 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Step 1 - Cohort 1- IPN10200
Participants will receive IPN10200 dose A through injections at Day 1.
IPN10200
Lyophilised powder
Step 1 - Cohort 1 - Placebo
Participants will receive placebo through injections at Day 1.
Placebo
Excipients without active substance, Lyophilised powder
Step 1 - Cohort 2 - IPN10200
Participants will receive IPN10200 dose B through injections at Day 1.
IPN10200
Lyophilised powder
Step 1 - Cohort 2 - Placebo
Participants will receive placebo through injections at Day 1.
Placebo
Excipients without active substance, Lyophilised powder
Step 2- EM group IPN10200 Dose A
Dose A will be administered to the participants in a single treatment cycle.
IPN10200 dose A
Lyophilised powder
Step 2- EM group IPN10200 Dose B
Dose B will be administered to the participants in a single treatment cycle
IPN10200 dose B
Lyophilised powder
Step 2- EM group placebo
Placebo will be administered to the participants in a single treatment cycle
Placebo
Excipients without active substance, Lyophilised powder
Step 2- CM group IPN10200 Dose A
Dose A will be administered to the participants in a single treatment cycle
IPN10200 dose A
Lyophilised powder
Step 2- CM group IPN10200 Dose B
Dose B will be administered to the participants in a single treatment cycle
IPN10200 dose B
Lyophilised powder
Step 2- CM group placebo
Placebo will be administered to the participants in a single treatment cycle
Placebo
Excipients without active substance, Lyophilised powder
Interventions
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IPN10200
Lyophilised powder
Placebo
Excipients without active substance, Lyophilised powder
IPN10200 dose A
Lyophilised powder
IPN10200 dose B
Lyophilised powder
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Central Research Associates
Birmingham, Alabama, United States
Rehabilitation & Neurological Services, LLC
Huntsville, Alabama, United States
MD First Research - Chandler - Neurology
Chandler, Arizona, United States
MD First Research - Chandler
Chandler, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Axiom Research, LLC
Apple Valley, California, United States
Profound Research. LLC - NCSC
Carlsbad, California, United States
M3Wake -PRI Encino
Encino, California, United States
WR-PRI Encino
Encino, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
Fullerton Neurological Center - Neurology
Fullerton, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
University of California, Irvine - Department of Neurology
Irvine, California, United States
Kaizen Brain Center
La Jolla, California, United States
Pharmacology Research Institute (PRI)
Los Alamitos, California, United States
Pharmacology Research Institute (PRI) - Los Alamitos/Long Beach
Newport Beach, California, United States
Profound Research, LLC
Pasadena, California, United States
Acclaim Clinical Research - Internal Medicine
San Diego, California, United States
Clinical Trials Management LLC
Thousand Oaks, California, United States
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California, United States
Advanced Neuroscience Research Center, LLC
Fort Collins, Colorado, United States
Advanced Neuroscience Research Center, LLC - Neurology
Fort Collins, Colorado, United States
New England Institute for Neurology and Headache (NEINH)/Medical Practice
Stamford, Connecticut, United States
Neurology Offices
Boca Raton, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
M3 Wake Research/MSRA, LLC
Lake City, Florida, United States
M3 Wake Research/MSRA,LLC
Lake City, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Emerald Coast Center For Neurological Disorders
Pensacola, Florida, United States
Conquest Research
Winter Park, Florida, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Crescent City Headache and Neurology Center, LLC
Chalmette, Louisiana, United States
Ochsner Health Center - Covington
Covington, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
DelRicht Research at Touro Medical Center
New Orleans, Louisiana, United States
LSU Healthcare Network Orthopedic & Sports Medicine
New Orleans, Louisiana, United States
MedStar Neurosciences and Rehabilitation Research Network
Baltimore, Maryland, United States
MedStar Neurosciences and Rehabilitation
Baltimore, Maryland, United States
MedStar Franklin Square Hospital Center
Baltimore, Maryland, United States
Medstar Franklin Square Medical Center
Baltimore, Maryland, United States
Neurology Center of NE,PC - Neurology
Foxborough, Massachusetts, United States
MedVadis Research
Waltham, Massachusetts, United States
Mass Institute of Clinical Research
Westborough, Massachusetts, United States
Michigan Head Pain & Neurological Institute - Neurology/Pain
Ann Arbor, Michigan, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Michigan Center of Medical Research
Grand Blanc, Michigan, United States
Minneapolis Clinic-Neurology
Burnsville, Minnesota, United States
Papillion Research Center/Avacare
Papillion, Nebraska, United States
Alliance Clinical Las Vegas (Excel Clinical Research) - Internal Medicine
Las Vegas, Nevada, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, United States
Montefiore Medical Center: Headache Center
The Bronx, New York, United States
Upstate Clinical Research Associates - Research Center
Williamsville, New York, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
UC Gardner Neuroscience Institute
Cincinnati, Ohio, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, United States
Mount Carmel Health Systems
New Albany, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians - Curry Hollow
Pittsburgh, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc - Memphis
Memphis, Tennessee, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Zenos Clinical Research - Internal Medicine
Dallas, Texas, United States
Lone Star Neurology
Frisco, Texas, United States
Elevate Clinical Research - Houston
Houston, Texas, United States
Javara Inc. - Houston, TX
Houston, Texas, United States
Javara Inc. - New Caney, TX
New Caney, Texas, United States
J. Lewis Research-Site Number:8400053
Salt Lake City, Utah, United States
ChronicleBio
West Valley City, Utah, United States
Puget Sound Neurology - Neurology
Tacoma, Washington, United States
Marshall Health Clinical Research Center
Huntington, West Virginia, United States
Frontier Clinical Research, LLC - Kingwood
Kingwood, West Virginia, United States
The Alfred Hospital - Neurology
Melbourne, , Australia
Western Health - Neurology & Stroke Services
Saint Albans, , Australia
The Royal Melbourne Hospital - Neurology
Victoria Park, , Australia
Instituto de Neurologia de Curitiba
Paraná, , Brazil
Associação Hospitalar Moinhos de Vento
Rio Grande, , Brazil
A2Z Clinical
São Paulo, , Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, , Brazil
Pseg Centro de Pesquisa Clínica S.A
São Paulo, , Brazil
CaRe Clinic - Calgary
Calgary, , Canada
University of Calgary Foothills Campus
Calgary, , Canada
Centre de Recherche Saint-Louis (Lévis) - Clinique Neuro-Lévis
Lévis, , Canada
Centre de Recherche Saint-Louis (Quebec) - Clinique Médicale Saint-Louis
Québec, , Canada
CaRe Clinic Red Deer
Red Deer, , Canada
Bluewater Clinical Research Group Inc.
Sarnia, , Canada
Pratia Brno s.r.o.
Brno, , Czechia
NEUROHK s.r.o.
Choceň, , Czechia
NeuropsychiatrieHK, s.r.o.
Hradec Králové, , Czechia
Fakultni nemocnice Ostrava - Neurologicka klinika
Ostrava, , Czechia
Pratia Pardubice a.s.
Pardubice, , Czechia
AXON clinical
Prague, , Czechia
DADO MEDICAL s.r.o.
Prague, , Czechia
CHU Amiens Sud-Centre Rech Clinique
Amiens, , France
Centre Hospitalier Regional Universtaire De Clermont-Ferrand - Neurologie
Clermont-Ferrand, , France
CHU de Nantes - 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
Countries
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Central Contacts
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Other Identifiers
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CLIN-10200-454
Identifier Type: -
Identifier Source: org_study_id