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MinorEnrollment closed, study ongoingTrial sites reduced: 166 → 162 locations · Enrollment target: estimated 641 to confirmed 670v22Show 2 more changesShow less
Trial sites reduced: 166 → 162 locations
Enrollment target: estimated 641 to confirmed 670
MinorInterventions: IPN10200 (Biological), IPN10200 dose A (Biological), IPN10200 dose B (Biological), Placebo (Other) to Corabotase (Biological), Corabotase dose A (Biological), Corabotase dose B (Biological), Placebo (Other)Study description revisedv21Show 1 more changeShow less
NotablePrimary completion pushed from Jan 31, 2027 to Oct 31, 2027v20
MinorPrimary completion moved earlier from May 31, 2027 to Jan 31, 2027Completion pushed from Jun 15, 2027 to Oct 31, 2027 · Site details revised at 38 of 166 sitesv19Show 2 more changesShow less
Completion pushed from Jun 15, 2027 to Oct 31, 2027
Site details revised at 38 of 166 sites
Minor2 versionsRe-verified since Dec 29, 2025, no change to tracked fieldsv17-v18
Show 15 earlier versionsHide 15 earlier versions
MinorStudy sites: 23 to 166v16
Minor2 versionsRe-verified since Sep 29, 2025, no change to tracked fieldsv14-v15
MinorStudy sites: 16 to 23v13
Minor4 versionsRe-verified since Apr 30, 2025, no change to tracked fieldsv9-v12
MinorStudy sites: 15 to 16v8
MinorRe-verified, no change to tracked fieldsv7
MinorSite details revised at 1 of 15 sitesv6
MinorEligibility criteria shortened, about 12 wordsSecondary endpoints: 7 to 9 · Site details revised at 1 of 15 sitesv5Show 2 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 1 · Start date changed from estimate of Oct 7, 2024 to Oct 10, 2024v2Show 2 more changesShow less
Study sites: 0 to 1
Start date changed from estimate of Oct 7, 2024 to Oct 10, 2024
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.