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

NCT06625060 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 641

Last updated 2026-05-05

No results posted yet for this 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

  • Episodic Migraine
  • Chronic Migraine

Interventions

BIOLOGICAL

IPN10200

Lyophilised powder

OTHER

Placebo

Excipients without active substance, Lyophilised powder

BIOLOGICAL

IPN10200 dose A

Lyophilised powder

BIOLOGICAL

IPN10200 dose B

Lyophilised powder

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2027-01-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Czechia
  • France
  • Georgia
  • Germany
  • Japan
  • New Zealand
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06625060 on ClinicalTrials.gov