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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Episodic Migraine, Chronic Migraine

In brief

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.

Key facts

Study ID: NCT06625060
Run by: Ipsen
People needed: 641
Starts: 2024-10-10
Expected to finish: 2027-10-31
Last updated by the study team: 2026-07-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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;
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;

Where it is running

Emerald Coast Center For Neurological Disorders — Pensacola, Florida, United States (enrolling)
LSU Healthcare Network Orthopedic & Sports Medicine — New Orleans, Louisiana, United States (enrolling)
M3 Wake Research/MSRA, LLC — Lake City, Florida, United States (enrolling)
Renstar Medical Research — Ocala, Florida, United States (enrolling)
DelRicht Research at Touro Medical Center — New Orleans, Louisiana, United States (enrolling)
Profound Research. LLC - NCSC — Carlsbad, California, United States (enrolling)
M3Wake -PRI Encino — Encino, California, United States (enrolling)
MD First Research - Chandler — Chandler, Arizona, United States (enrolling)
Rehabilitation & Neurological Services, LLC — Huntsville, Alabama, United States (enrolling)
M3 Wake Research/MSRA,LLC — Lake City, Florida, United States (enrolling)
Crescent City Headache and Neurology Center, LLC — Chalmette, Louisiana, United States (enrolling)
DelRicht Research — New Orleans, Louisiana, United States (enrolling)
Kaizen Brain Center — La Jolla, California, United States (enrolling)
Pharmacology Research Institute (PRI) — Los Alamitos, California, United States (enrolling)
Pharmacology Research Institute (PRI) - Los Alamitos/Long Beach — Newport Beach, California, United States (enrolling)
Profound Research, LLC — Pasadena, California, United States (enrolling)
WR-PRI Encino — Encino, California, United States (enrolling)
Clinical Trials Management LLC — Thousand Oaks, California, United States (enrolling)
Neuro-Pain Medical Center — Fresno, California, United States (enrolling)
Advanced Neuroscience Research Center, LLC — Fort Collins, Colorado, United States (enrolling)
Advanced Neuroscience Research Center, LLC - Neurology — Fort Collins, Colorado, United States (enrolling)
Fullerton Neurological Center - Neurology — Fullerton, California, United States (enrolling)
Neurology Offices — Boca Raton, Florida, United States (enrolling)
MD First Research - Chandler - Neurology — Chandler, Arizona, United States (enrolling)
MedStar Neurosciences and Rehabilitation Research Network — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.