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A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults
NCT06625060 · View on ClinicalTrials.gov ↗
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. 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 IPN10200 directly into the muscles of the head and neck to prevent EM and CM, * The right amount (dose) of IPN10200 to inject at each point, * The total amount (dose) of IPN10200 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.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL IPN10200
- BIOLOGICAL IPN10200 dose A
- BIOLOGICAL IPN10200 dose B
Study Locations (20)
California
- Axiom Research, LLC — Apple Valley
- Profound Research. LLC - NCSC — Carlsbad
- M3Wake -PRI Encino — Encino
- WR-PRI Encino — Encino
- Neuro-Pain Medical Center — Fresno
- Fullerton Neurological Center - Neurology — Fullerton
- Neurology Center of North Orange County — Fullerton
- University of California, Irvine - Department of Neurology — Irvine
- Kaizen Brain Center — La Jolla
- Pharmacology Research Institute (PRI) — Los Alamitos
- Pharmacology Research Institute (PRI) - Los Alamitos/Long Beach — Newport Beach
- Profound Research, LLC — Pasadena
- Acclaim Clinical Research - Internal Medicine — San Diego
- Clinical Trials Management LLC — Thousand Oaks
- Alliance Clinical West Hills (Focus Clinical Research) — West Hills
Alabama
- Central Research Associates — Birmingham
- Rehabilitation & Neurological Services, LLC — Huntsville
Arizona
- MD First Research - Chandler - Neurology — Chandler
- MD First Research - Chandler — Chandler
Arkansas
- Baptist Health Center for Clinical Research — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 641 participants |
| Start Date | 2024-10-10 |
| Est. Completion | 2027-06-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06625060
The ClinicalTrials.gov registry entry for NCT06625060 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 641 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 205 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Chronic Migraine appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06625060 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06625060 about?
NCT06625060 is a clinical study titled "A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults". 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 ...
What is the current status of trial NCT06625060?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 641 participants. The study started on 2024-10-10. Estimated completion is 2027-06-15.
What conditions does trial NCT06625060 study?
This clinical trial studies the following conditions: Chronic Migraine, Episodic Migraine. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06625060?
The interventions under investigation include: Placebo (OTHER), IPN10200 (BIOLOGICAL), IPN10200 dose A (BIOLOGICAL), IPN10200 dose B (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06625060?
This trial is sponsored by Ipsen, which has 205 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06625060 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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