A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults (NCT06625060)
A Multicentre, Randomised, Double-blind, Placebo-controlled, Dose Escalation and Dose Finding Phase II Study to Evaluate the Safety and Efficacy of IPN10200 in the Prevention of Episodic or Chronic Migraine in Adults
๐ฉบ Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Central Research Associates โ Birmingham, Alabama
Age range: 18 Years to 80 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (166 Sites)
Showing the first 25 of 166 sites.
- Central Research Associates โ Birmingham, Alabama
- Rehabilitation & Neurological Services, LLC โ Huntsville, Alabama
- MD First Research - Chandler - Neurology โ Chandler, Arizona
- MD First Research - Chandler โ Chandler, Arizona
- Baptist Health Center for Clinical Research โ Little Rock, Arkansas
- Axiom Research, LLC โ Apple Valley, California
- Profound Research. LLC - NCSC โ Carlsbad, California
- M3Wake -PRI Encino โ Encino, California
- WR-PRI Encino โ Encino, California
- Neuro-Pain Medical Center โ Fresno, California
- Fullerton Neurological Center - Neurology โ Fullerton, California
- Neurology Center of North Orange County โ Fullerton, California
- University of California, Irvine - Department of Neurology โ Irvine, California
- Kaizen Brain Center โ La Jolla, California
- Pharmacology Research Institute (PRI) โ Los Alamitos, California
- Pharmacology Research Institute (PRI) - Los Alamitos/Long Beach โ Newport Beach, California
- Profound Research, LLC โ Pasadena, California
- Acclaim Clinical Research - Internal Medicine โ San Diego, California
- Clinical Trials Management LLC โ Thousand Oaks, California
- Alliance Clinical West Hills (Focus Clinical Research) โ West Hills, California
- Advanced Neuroscience Research Center, LLC โ Fort Collins, Colorado
- Advanced Neuroscience Research Center, LLC - Neurology โ Fort Collins, Colorado
- New England Institute for Neurology and Headache (NEINH)/Medical Practice โ Stamford, Connecticut
- Neurology Offices โ Boca Raton, Florida
- AGA Clinical Trials โ Hialeah, Florida
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Episodic Migraine
- A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine โ Huntsville, Alabama
- A Study to Evaluate the Effectiveness and Safety of Dysportยฎ for the Prevention of Episodic Migraine in Adults โ Birmingham, Alabama
- Efficacy of Nerve Blocks for Episodic Migraine โ Rochester, Minnesota
- Chiropractic Care for Episodic Migraine โ Boston, Massachusetts
- A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine โ Huntsville, Alabama
- A Clinical Trial to Evaluate Efficacy and Safety of Xeominยฎ Injections for Preventing Episodic Migraine โ Chandler, Arizona
Explore by condition: All Episodic Migraine clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.