A Phase 2 interventional study of Corabotase and Placebo in Episodic Migraine and Chronic Migraine, sponsored by Ipsen. Active, not recruiting at 162 sites in 14 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Ipsen · Phase 2, Interventional, and Treatment
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:
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.
The study will consist of 3 periods:
Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants presenting with a swallowing disorder of any origin which might be exacerbated by botulinum toxin treatment, such as:
- Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing difficulties and requiring a change in diet.
Use of any of the following medications in the specified timeframe prior to the screening visit:
Participants will receive Corabotase dose A through injections at Day 1.
Biological: Corabotase
Participants will receive placebo through injections at Day 1.
Other: Placebo
Participants will receive Corabotase dose B through injections at Day 1.
Biological: Corabotase
Participants will receive placebo through injections at Day 1.
Other: Placebo
Dose A will be administered to the participants in a single treatment cycle.
Biological: Corabotase dose A
Dose B will be administered to the participants in a single treatment cycle
Biological: Corabotase dose B
Placebo will be administered to the participants in a single treatment cycle
Other: Placebo
Dose A will be administered to the participants in a single treatment cycle
Biological: Corabotase dose A
Dose B will be administered to the participants in a single treatment cycle
Biological: Corabotase dose B
Placebo will be administered to the participants in a single treatment cycle
Other: Placebo
Lyophilised powder
Excipients without active substance, Lyophilised powder
Lyophilised powder
Lyophilised powder
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
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.
Time frame: For step 1: From baseline until end of study at Week 36
Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters
Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator.
Time frame: For step 1: At all timepoints post injection until Week 36
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
Time frame: For step 1: At all timepoints post injection until Week 36
Percentage of participants with clinically significant change from baseline in facial examination
Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.
Time frame: For step 1: At all timepoints post injection until Week 36
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
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.
Time frame: For step 1: At all timepoints post injection until Week 36
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).
Change from baseline in the number of MMD
Time frame: For Step 1 and step 2: From Week 1 to Week 36.
Change from baseline in the number of Monthly Headache Days (MHD)
Time frame: For Step 1 and step 2: From Week 1 to Week 36
Change from baseline in the number of moderate/severe MHD
Time frame: For Step 1 and step 2: From Week 1 to Week 36
Migraine prevention response
Migraine prevention response is assessed using two thresholds: by a reduction from baseline of either ≥50% or ≥75% in MMD
Time frame: For Step 1 and step 2: From Week 1 to Week 36
Headache prevention response
Assessed using two thresholds: by a reduction from baseline of either ≥50% or ≥ 75% in MHD
Time frame: For Step 1 and step 2: From Week 1 to Week 36.
Change from baseline in the number of days per 4 week period of acute medication use for migraine relief.
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.
Time frame: For Step 1 and step 2: From Week 1 to Week 36.
The use of acute migraine medication (yes or no)
The use of acute migraine medication will be recorded in the daily eDiary.
Time frame: For Step 1 and step 2: From Week 1 to Week 36.
Percentage of participants with Binding antibodies to IPN10200
Time frame: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.
Percentage of participants with neutralising antibodies to IPN10200
Time frame: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.
Showing the first 100 of 162 sites across 14 countries.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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