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IPN10200 for Migraine Prevention (MERANTI Trial)

Phase 2
Recruiting
Research Sponsored by Ipsen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 18 to 80 years at the time of signing the informed consent
Diagnosis of migraine at ≤50 years of age
Must not have
Pregnant, nursing, premenopausal women, or WOCBP not willing to practice contraception
Receiving more than one allowable concomitant migraine preventive treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for step 1 and step 2: from week 1 to week 36

Summary

"This trial is testing a new medication, IPN10200, for the treatment of episodic migraine (EM) and chronic migraine (CM). The medication aims to stop the release of chemicals that cause

Who is the study for?
Adults aged 18-80 with a history of episodic or chronic migraines, diagnosed before age 50 and lasting at least 12 months. Participants must have tried one migraine prevention treatment, be able to consent, and record their headache frequency in an eDiary. Those with chronic migraines should have ≥15 headache days per month; for episodic migraines ≤14 headache days but ≥6 migraine days are required.
What is being tested?
The trial is testing IPN10200's ability to prevent severe headaches in adults by injecting it into the muscles of the head and neck. It will determine the safest and most effective dose for reducing migraine frequency as recorded in participants' daily electronic diaries over up to 44 weeks.
What are the potential side effects?
While specific side effects are not listed here, generally such interventions could include injection site reactions, muscle pain or weakness around the injected area, potential allergic reactions or systemic effects like fatigue or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I was diagnosed with migraine before turning 51.
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I have been diagnosed with episodic migraines and meet the headache frequency criteria.
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I have chronic migraines and meet the headache frequency criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, nursing, or if capable of becoming pregnant, I agree to use contraception.
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I am taking more than one approved preventive migraine treatment.
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I have a history of specific types of headaches.
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I am a man and will not use condoms with a partner who can get pregnant.
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My headache is caused by another condition, not by overusing medication.
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I have difficulty swallowing.
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I have a neuromuscular or respiratory condition that affects my safety.
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I have a significant skin condition or infection.
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I have been diagnosed with a significant pain disorder.
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My migraine prevention medications have not worked well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for step 1 and step 2: from week 1 to week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and for step 1 and step 2: from week 1 to week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters
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
+2 more
Secondary study objectives
Change from baseline in the number of days per 4 week period of acute medication use for migraine relief.
Headache prevention response
Migraine prevention response
+1 more

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Step 2- EM group IPN10200 Dose BExperimental Treatment1 Intervention
Dose B will be administered to the participants in a single treatment cycle
Group II: Step 2- EM group IPN10200 Dose AExperimental Treatment1 Intervention
Dose A will be administered to the participants in a single treatment cycle.
Group III: Step 2- CM group IPN10200 Dose BExperimental Treatment1 Intervention
Dose B will be administered to the participants in a single treatment cycle
Group IV: Step 2- CM group IPN10200 Dose AExperimental Treatment1 Intervention
Dose A will be administered to the participants in a single treatment cycle
Group V: Step 1 - Cohort 2 - IPN10200Experimental Treatment1 Intervention
Participants will receive IPN10200 dose B through injections at Day 1.
Group VI: Step 1 - Cohort 1- IPN10200Experimental Treatment1 Intervention
Participants will receive IPN10200 dose A through injections at Day 1.
Group VII: Step 1 - Cohort 1 - PlaceboPlacebo Group1 Intervention
Participants will receive placebo through injections at Day 1.
Group VIII: Step 1 - Cohort 2 - PlaceboPlacebo Group1 Intervention
Participants will receive placebo through injections at Day 1.
Group IX: Step 2- CM group placeboPlacebo Group1 Intervention
Placebo will be administered to the participants in a single treatment cycle
Group X: Step 2- EM group placeboPlacebo Group1 Intervention
Placebo will be administered to the participants in a single treatment cycle

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor
351 Previous Clinical Trials
73,731 Total Patients Enrolled
1 Trials studying Migraine
138 Patients Enrolled for Migraine
Ipsen Medical DirectorStudy DirectorIpsen
260 Previous Clinical Trials
55,617 Total Patients Enrolled
1 Trials studying Migraine
138 Patients Enrolled for Migraine
~427 spots leftby May 2027
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