NCT06625060 · Ipsen
A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults
(MERANTI)
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
IPN10200
Lyophilised powder
OTHER
Placebo
Excipients without active substance, Lyophilised powder
BIOLOGICAL
IPN10200 dose A
Lyophilised powder
BIOLOGICAL
IPN10200 dose B
Lyophilised powder
Primary outcome measures
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
Time frame: For step 1: From baseline until end of study at Week 36
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.
Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters
Time frame: For step 1: At all timepoints post injection until Week 36
Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator.
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Time frame: For step 1: At all timepoints post injection until Week 36
Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
Percentage of participants with clinically significant change from baseline in facial examination
Time frame: For step 1: At all timepoints post injection until Week 36
Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings
Time frame: For step 1: At all timepoints post injection until Week 36
Treatment-emergence of suicidal ideation/suicidal behaviour
Time frame: For step 1: At all timepoints post injection until Week 36
It will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire that consists of 2 subscales: 1. Ideation severity subscale: questions answered yes/no, severity of ideation scored 1-5 with 5 being most severe 2. Intensity of ideation subscale : scores range from 2-25 with higher scores indicating more severe intensity of ideation.
Percentage of participants with Binding antibodies to IPN10200
Time frame: For step 1: At baseline, Week 4, Week 12 and Week 36.
Percentage of participants with neutralising antibodies to IPN10200
Time frame: For step 1: At baseline, Week 4, Week 12 and Week 36.
Change from baseline in the number of Monthly migraine days (MMD)s
Time frame: For step 2: At Week 12 (Weeks 9-12).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Huntsville, Alabama
- Chandler, Arizona
- Little Rock, Arkansas
- Apple Valley, California
- Carlsbad, California
- Encino, California
- Fresno, California
- Fullerton, California
- Irvine, California
- La Jolla, California
- Los Alamitos, California
And 45 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations