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NCT06625060 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults

A Phase 2 study of Chronic Migraine and Episodic Migraine, sponsored by Ipsen.

Recruiting
Registry status
Phase 2
Development phase
641
Enrollment target
20
Study locations

NCT06625060 is a Phase 2 study of Chronic Migraine and Episodic Migraine that is actively recruiting participants, run by Ipsen. The registered enrollment target is 641 participants, above the 306-participant average among 17 other Chronic Migraine trials with a reported enrollment target (109% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT06625060, a Phase 2 study of Chronic Migraine and Episodic Migraine, is actively recruiting participants, sponsored by Ipsen.

RECRUITING
Registry status
Phase 2
Development phase
641 participants
Enrollment target
20
Study locations

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.

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

FieldValue
Enrollment Target 641 participants
Start Date 2024-10-10
Est. Completion 2027-06-15
Phase Phase 2

Sponsor

Ipsen

85 total trials

What the Registry Record Tells You About NCT06625060

The ClinicalTrials.gov registry entry for NCT06625060 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 641 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 306-participant average among 17 other Chronic Migraine trials with a reported enrollment target (109% higher). The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.

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.

NCT06625060 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.

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.

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).

Who is sponsoring clinical trial NCT06625060?

This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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