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Study of IPN10200 compared to placebo for prevention of episodic or chronic migraine in adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with episodic migraine or chronic migraine, which are conditions causing severe headaches. The research evaluates a new medication called IPN10200, which contains Clostridium botulinum neurotoxin, administered as an intramuscular injection. Some participants will receive the study medication while others will receive a placebo. The purpose is to determine if IPN10200 is effective in preventing migraines and to assess its safety.

The study medication or placebo will be given as a single treatment cycle. Throughout the study, participants will need to track their headaches and migraine days using an electronic diary. The study will monitor various aspects of participants' health, including any changes in their condition and how their body responds to the treatment. The total duration of participation for each person will be 36 weeks.

During the study, researchers will evaluate how the treatment affects the number of days participants experience migraines each month. They will also monitor the use of other migraine medications and assess whether the study medication helps reduce both the frequency and severity of headaches. Regular health checks will be performed to ensure participant safety throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and diagnosis confirmation

    Your eligibility for the study will be verified based on your migraine history and current condition

    The study accepts patients aged 18-80 who have been diagnosed with migraine before age 50

    You must have experienced migraines for at least 12 months before screening

  2. Step 2

    Electronic diary setup and baseline monitoring

    You will receive an electronic diary to record your headache experiences

    For episodic migraine: You must have 14 or fewer headache days and at least 6 migraine days in 4 weeks

    For chronic migraine: You must have 15 or more headache days and at least 8 migraine days in 4 weeks

  3. Step 3

    Treatment administration

    You will receive either IPN10200 or placebo through intramuscular injection

    This is a single treatment cycle study

    Neither you nor your doctor will know which treatment you receive

  4. Step 4

    Follow-up monitoring

    Regular check-ups will occur over 36 weeks

    Blood tests will be taken at weeks 4, 12, and 36

    You will undergo facial examinations and heart monitoring (ECG)

    Your electronic diary entries will continue throughout the study

    Regular vital signs and laboratory tests will be conducted

  5. Step 5

    Safety and effectiveness monitoring

    Your migraine frequency and severity will be tracked

    Any use of acute migraine medications must be recorded in your electronic diary

    Any side effects or health changes will be monitored and documented

    Tests for antibodies will be conducted at specific intervals

Who can join the trial?

9 criteria

  • Must be able to provide written informed consent and agree to follow study requirements
  • Age between 18 and 80 years old
  • Must have been diagnosed with either episodic migraine or chronic migraine for at least 12 months before screening
  • Must have received first migraine diagnosis before age 50
  • For patients with episodic migraine:
    • Must have 14 or fewer headache days in 4 weeks before starting the study
    • Must have at least 6 migraine days in 4 weeks before starting the study
    • For patients with chronic migraine:
      • Must have 15 or more headache days in 4 weeks before starting the study
      • Must have at least 8 migraine days in 4 weeks before starting the study
      • Must have previously used at least one preventive treatment for migraines

Who cannot join the trial?

15 criteria

  • Age less than 18 years or over 65 years old
  • Currently pregnant or breastfeeding women
  • History of any other type of headache disorder that could interfere with the diagnosis of migraine
  • Use of other preventive medications for migraine within 30 days before the study
  • Previous failure to respond to 2 or more classes of preventive migraine medications
  • History of serious allergic reactions to similar medications
  • Significant medical conditions that could affect the study results
  • Current participation in other clinical trials
  • History of substance abuse in the past 12 months
  • Mental health conditions that could interfere with study participation
  • Unable to follow study procedures or complete required documentation
  • History of chronic pain conditions other than migraine
  • Recent surgery within the past 3 months
  • Uncontrolled high blood pressure
  • History of severe cardiovascular disease (heart problems)
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Investigated drugs

IPN10200 is an investigational medication being studied for preventing both episodic and chronic migraine in adults. It is being tested as a single treatment cycle to see if it can reduce the frequency of migraine headaches. The medication is being evaluated for its safety and how well the body tolerates it. The researchers are also studying whether the body might develop an immune response to the medication.

What is already known about the treatment

IPN10200 - An investigational medication being studied in Phase II clinical trials for the prevention of episodic and chronic migraine in adults. The drug is being evaluated through a double-blind, placebo-controlled study design to assess its safety, tolerability, and efficacy in migraine prevention. While the specific mechanism of action is still under investigation as part of the clinical trial process, the medication is being developed as a preventive treatment that aims to reduce the frequency and severity of migraine attacks in both episodic and chronic migraine patients. The study includes assessment of potential immunogenicity, suggesting it may be a biologic agent, though its exact pharmacological classification remains to be fully established through the ongoing clinical research.

Investigated diseases

  • Episodic Migraine

    A neurological condition characterized by recurring headache attacks that occur less than 15 days per month. These headaches typically cause moderate to severe throbbing pain, often on one side of the head, and can last between 4-72 hours. Episodes are frequently accompanied by nausea, sensitivity to light and sound, and may be preceded by visual or sensory disturbances called auras.

  • Chronic Migraine

    A persistent neurological condition where headaches occur on 15 or more days per month, with at least 8 of those days featuring migraine characteristics, for more than three months. The headaches often cause pulsating pain of varying intensity and can be accompanied by nausea, vomiting, and heightened sensitivity to environmental stimuli. The condition can fluctuate in severity and frequency over time, with symptoms similar to episodic migraine but occurring more frequently.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511101-28-00Protocol codeCLIN-10200-454Estimated enrolment698 patientsSponsorIpsen Innovation

sourced from the EU Clinical Trials Register and site verification

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