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

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
MD First Research - Chandler
RECRUITING
Chandler
California
Profound Research. LLC - NCSC
RECRUITING
Carlsbad
WR-PRI Encino
RECRUITING
Encino
Neuro-Pain Medical Center
RECRUITING
Fresno
Pharmacology Research Institute (PRI)
RECRUITING
Los Alamitos
Profound Research, LLC
RECRUITING
Pasadena
Clinical Trials Management LLC
RECRUITING
Thousand Oaks
Colorado
Advanced Neuroscience Research Center, LLC
RECRUITING
Fort Collins
Florida
M3 Wake Research/MSRA, LLC
RECRUITING
Lake City
Louisiana
Crescent City Headache and Neurology Center, LLC
RECRUITING
Chalmette
DelRicht Research at Touro Medical Center
RECRUITING
New Orleans
LSU Healthcare Network Orthopedic & Sports Medicine
RECRUITING
New Orleans
Maryland
MedStar Franklin Square Hospital Center
RECRUITING
Baltimore
MedStar Neurosciences and Rehabilitation
NOT_YET_RECRUITING
Baltimore
MedStar Neurosciences and Rehabilitation Research Network
RECRUITING
Baltimore
Michigan
Michigan Head Pain & Neurological Institute
RECRUITING
Ann Arbor
New York
Integrative Clinical Trials, LLC
RECRUITING
Brooklyn
Montefiore Medical Center: Headache Center
RECRUITING
The Bronx
Upstate Clinical Research Associates
RECRUITING
Williamsville
Ohio
Neurology Diagnostics, Inc.
RECRUITING
Dayton
Pennsylvania
Preferred Primary Care Physicians - Curry Hollow
RECRUITING
Pittsburgh
Tennessee
Clinical Neuroscience Solutions, Inc - Memphis
RECRUITING
Memphis
Washington
Puget Sound Neurology - Neurology
RECRUITING
Tacoma
Contact Information
Primary
Ipsen Clinical Study Enquiries
clinical.trials@ipsen.com
See e mail
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2027-06-15
Participants
Target number of participants: 641
Treatments
Experimental: Step 1 - Cohort 1- IPN10200
Participants will receive IPN10200 dose A through injections at Day 1.
Placebo_comparator: Step 1 - Cohort 1 - Placebo
Participants will receive placebo through injections at Day 1.
Experimental: Step 1 - Cohort 2 - IPN10200
Participants will receive IPN10200 dose B through injections at Day 1.
Placebo_comparator: Step 1 - Cohort 2 - Placebo
Participants will receive placebo through injections at Day 1.
Experimental: Step 2- EM group IPN10200 Dose A
Dose A will be administered to the participants in a single treatment cycle.
Experimental: Step 2- EM group IPN10200 Dose B
Dose B will be administered to the participants in a single treatment cycle
Placebo_comparator: Step 2- EM group placebo
Placebo will be administered to the participants in a single treatment cycle
Experimental: Step 2- CM group IPN10200 Dose A
Dose A will be administered to the participants in a single treatment cycle
Experimental: Step 2- CM group IPN10200 Dose B
Dose B will be administered to the participants in a single treatment cycle
Placebo_comparator: Step 2- CM group placebo
Placebo will be administered to the participants in a single treatment cycle
Related Therapeutic Areas
Sponsors
Leads: Ipsen

This content was sourced from clinicaltrials.gov

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