A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migrain… (NCT06625060) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults
United States, Australia, Brazil641 participantsStarted 2024-10-10
Plain-language 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. 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: For step 1: From baseline until end of study at Week 36
2
Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters
Timeframe: For step 1: At all timepoints post injection until Week 36
3
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Timeframe: For step 1: At all timepoints post injection until Week 36
4
Percentage of participants with clinically significant change from baseline in facial examination
Timeframe: For step 1: At all timepoints post injection until Week 36
5
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings
Timeframe: For step 1: At all timepoints post injection until Week 36
6
Treatment-emergence of suicidal ideation/suicidal behaviour
Timeframe: For step 1: At all timepoints post injection until Week 36
. 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.
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;
. 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:
. 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;
7
Percentage of participants with Binding antibodies to IPN10200
Timeframe: For step 1: At baseline, Week 4, Week 12 and Week 36.
8
Percentage of participants with neutralising antibodies to IPN10200
Timeframe: For step 1: At baseline, Week 4, Week 12 and Week 36.
9
Change from baseline in the number of Monthly migraine days (MMD)s