A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults
Condition(s) studied
Investigational drug(s) / intervention(s)
Corabotase: Lyophilised powder
Placebo: Excipients without active substance, Lyophilised powder
Corabotase dose A: Lyophilised powder
Corabotase dose B: Lyophilised powder
Study 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.
Eligibility
Primary outcome measure(s)
- 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 — 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 — 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 — 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 — 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 — For step 1: At all timepoints post injection until Week 36
- Treatment-emergence of suicidal ideation/suicidal behaviour — 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 — For step 1: At baseline, Week 4, Week 12 and Week 36.
- Percentage of participants with neutralising antibodies to IPN10200 — For step 1: At baseline, Week 4, Week 12 and Week 36.
- Change from baseline in the number of Monthly migraine days (MMD)s — For step 2: At Week 12 (Weeks 9-12).
Trial sites (162)
| Facility | City | Region | Status |
|---|---|---|---|
| Central Research Associates | Birmingham | Alabama | |
| Rehabilitation & Neurological Services, LLC | Huntsville | Alabama | |
| MD First Research - Chandler - Neurology | Chandler | Arizona | |
| MD First Research - Chandler | Chandler | Arizona | |
| Axiom Research, LLC | Apple Valley | California | |
| Profound Research. LLC - NCSC | Carlsbad | California | |
| M3Wake -PRI Encino | Encino | California | |
| WR-PRI Encino | Encino | California | |
| Neuro-Pain Medical Center | Fresno | California | |
| Fullerton Neurological Center - Neurology | Fullerton | California | |
| Neurology Center of North Orange County | Fullerton | California | |
| Kaizen Brain Center | La Jolla | California | |
| Pharmacology Research Institute (PRI) | Los Alamitos | California | |
| Pharmacology Research Institute (PRI) - Los Alamitos/Long Beach | Newport Beach | California | |
| Profound Research, LLC | Pasadena | California | |
| Acclaim Clinical Research - Internal Medicine | San Diego | California | |
| Clinical Trials Management LLC | Thousand Oaks | California | |
| Alliance Clinical West Hills (Focus Clinical Research) | West Hills | California | |
| Advanced Neuroscience Research Center, LLC | Fort Collins | Colorado | |
| Advanced Neuroscience Research Center, LLC - Neurology | Fort Collins | Colorado | |
| New England Institute for Neurology and Headache (NEINH)/Medical Practice | Stamford | Connecticut | |
| Neurology Offices | Boca Raton | Florida | |
| AGA Clinical Trials | Hialeah | Florida | |
| M3 Wake Research/MSRA, LLC | Lake City | Florida | |
| M3 Wake Research/MSRA,LLC | Lake City | Florida | |
| Renstar Medical Research | Ocala | Florida | |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | |
| Emerald Coast Center For Neurological Disorders | Pensacola | Florida | |
| Conquest Research | Winter Park | Florida | |
| NeuroTrials Research, Inc. | Atlanta | Georgia | |
| Crescent City Headache and Neurology Center, LLC | Chalmette | Louisiana | |
| Ochsner Health Center - Covington | Covington | Louisiana | |
| DelRicht Research | New Orleans | Louisiana | |
| DelRicht Research at Touro Medical Center | New Orleans | Louisiana | |
| LSU Healthcare Network Orthopedic & Sports Medicine | New Orleans | Louisiana | |
| MedStar Neurosciences and Rehabilitation Research Network | Baltimore | Maryland | |
| MedStar Neurosciences and Rehabilitation | Baltimore | Maryland | |
| MedStar Franklin Square Hospital Center | Baltimore | Maryland | |
| Medstar Franklin Square Medical Center | Baltimore | Maryland | |
| Neurology Center of NE,PC - Neurology | Foxborough | Massachusetts |
+ 122 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06625060 on ClinicalTrials.gov ↗ ← All trials in Australia