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

Purpose

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.

Conditions

Episodic Migraine
Chronic Migraine

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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 Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Model Description
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Masking Description

Arm Groups

Arm	Description	Assigned Intervention
Experimental Step 1 - Cohort 1- IPN10200	Participants will receive IPN10200 dose A through injections at Day 1.	Biological: IPN10200 Lyophilised powder
Placebo Comparator Step 1 - Cohort 1 - Placebo	Participants will receive placebo through injections at Day 1.	Other: Placebo Excipients without active substance, Lyophilised powder
Experimental Step 1 - Cohort 2 - IPN10200	Participants will receive IPN10200 dose B through injections at Day 1.	Biological: IPN10200 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
Experimental Step 2- EM group IPN10200 Dose A	Dose A will be administered to the participants in a single treatment cycle.	Biological: IPN10200 dose A Lyophilised powder
Experimental Step 2- EM group IPN10200 Dose B	Dose B will be administered to the participants in a single treatment cycle	Biological: IPN10200 dose B 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
Experimental Step 2- CM group IPN10200 Dose A	Dose A will be administered to the participants in a single treatment cycle	Biological: IPN10200 dose A Lyophilised powder
Experimental Step 2- CM group IPN10200 Dose B	Dose B will be administered to the participants in a single treatment cycle	Biological: IPN10200 dose B 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

Recruiting Locations

Rehabilitation & Neurological Services, LLC
Huntsville 4068590, Alabama 4829764 35801

MD First Research - Chandler - Neurology
Chandler 5289282, Arizona 5551752 85224

MD First Research - Chandler
Chandler 5289282, Arizona 5551752 85286

Baptist Health Center for Clinical Research
Little Rock 4119403, Arkansas 4099753 72205

Profound Research. LLC - NCSC
Carlsbad 5334223, California 5332921 92011

M3Wake -PRI Encino
Encino 5346649, California 5332921 91316

WR-PRI Encino
Encino 5346649, California 5332921 91316

Neuro-Pain Medical Center
Fresno 5350937, California 5332921 93710

Kaizen Brain Center
La Jolla 5363943, California 5332921 92037

Pharmacology Research Institute (PRI)
Los Alamitos 5368304, California 5332921 90720

Pharmacology Research Institute (PRI) - Los Alamitos/Long Beach
Newport Beach 5376890, California 5332921 92660

Profound Research, LLC
Pasadena 5381396, California 5332921 91105

Clinical Trials Management LLC
Thousand Oaks 5402405, California 5332921 91360

Advanced Neuroscience Research Center, LLC
Fort Collins 5577147, Colorado 5417618 80501

Advanced Neuroscience Research Center, LLC - Neurology
Fort Collins 5577147, Colorado 5417618 80524

Neurology Offices
Boca Raton 4148411, Florida 4155751 33432

M3 Wake Research/MSRA, LLC
Lake City 4161187, Florida 4155751 32055

M3 Wake Research/MSRA,LLC
Lake City 4161187, Florida 4155751 32055

Renstar Medical Research
Ocala 4166673, Florida 4155751 34471

Emerald Coast Center For Neurological Disorders
Pensacola 4168228, Florida 4155751 32502

Crescent City Headache and Neurology Center, LLC
Chalmette 4319518, Louisiana 4331987 70043

DelRicht Research
New Orleans 4335045, Louisiana 4331987 70112

DelRicht Research at Touro Medical Center
New Orleans 4335045, Louisiana 4331987 70115

LSU Healthcare Network Orthopedic & Sports Medicine
New Orleans 4335045, Louisiana 4331987 70115

MedStar Neurosciences and Rehabilitation Research Network
Baltimore 4347778, Maryland 4361885 21218

MedStar Franklin Square Hospital Center
Baltimore 4347778, Maryland 4361885 21237

Medstar Franklin Square Medical Center
Baltimore 4347778, Maryland 4361885 21237

MedVadis Research
Waltham 4954380, Massachusetts 6254926 02451

Michigan Head Pain & Neurological Institute - Neurology/Pain
Ann Arbor 4984247, Michigan 5001836 48104

Michigan Head Pain & Neurological Institute
Ann Arbor 4984247, Michigan 5001836 48104

Michigan Center of Medical Research
Grand Blanc 4994320, Michigan 5001836 48439

Integrative Clinical Trials, LLC
Brooklyn 5110302, New York 5128638 11229

Montefiore Medical Center: Headache Center
The Bronx 5110266, New York 5128638 10461

Upstate Clinical Research Associates - Research Center
Williamsville 5144588, New York 5128638 14221

Upstate Clinical Research Associates
Williamsville 5144588, New York 5128638 14221

Neurology Diagnostics, Inc.
Dayton 4509884, Ohio 5165418 45459

Preferred Primary Care Physicians - Curry Hollow
Pittsburgh 5206379, Pennsylvania 6254927 15236

Clinical Neuroscience Solutions, Inc - Memphis
Memphis 4641239, Tennessee 4662168 38119

Clinical Neuroscience Solutions, Inc.
Memphis 4641239, Tennessee 4662168 38119

Elevate Clinical Research - Houston
Houston 4699066, Texas 4736286 77002

Javara Inc. - Houston, TX
Houston 4699066, Texas 4736286 77002

Javara Inc. - New Caney, TX
New Caney 4714149, Texas 4736286 77357

Puget Sound Neurology - Neurology
Tacoma 5812944, Washington 5815135 98409

More Details

NCT ID: NCT06625060
Status: Recruiting
Sponsor: Ipsen

Study Contact

Ipsen Clinical Study Enquiries
See e mail
clinical.trials@ipsen.com

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 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).