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Evaluating IPN10200 for Preventing Migraines in Adults

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

Phase 2 Interventional Ipsen · NCT06625060

This study is testing a new injection called IPN10200 to see if it can help adults prevent migraines from happening.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment641 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorIpsen Industry-sponsored
Locations166 sites (Birmingham, Alabama and 165 other locations)
Trial IDNCT06625060 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of IPN10200, a medication administered via injection into the muscles of the head and neck, for preventing episodic and chronic migraines in adults. The study consists of a screening period followed by two steps: the first assesses two different doses of the medication against a placebo, while the second randomly assigns participants to receive either of the doses or a placebo. Participants will be monitored for safety and efficacy over a 36-week period, focusing on the frequency of headache and migraine days.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosis of episodic or chronic migraine for at least 12 months.

Not a fit: Patients who do not meet the diagnostic criteria for episodic or chronic migraine or those with a history of migraine for less than 12 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of migraine attacks for patients.

How similar studies have performed: Other studies have shown promise in using similar injection-based approaches for migraine prevention, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF. Participant has provided written informed consent and signed privacy/data protection documentation;
2. Male or female ≥18 to 80 years of age at the time of signing the informed consent;
3. Diagnosis of either EM or CM, per ICHD-3 criteria, for at least 12 months prior to the screening visit;
4. Diagnosis of migraine at ≤50 years of age;
5. Participants in the EM group: History of EM diagnosis and headache frequency (i.e. migraine and non-migraine headache): ≤14 headache days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary; migraine frequency: ≥6 migraine days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary;
6. Participants in the CM group: History of CM diagnosis and headache frequency (i.e. migraine and non-migraine headache): ≥15 headache days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary; migraine frequency: ≥8 migraine days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary;
7. Participant with a history of use of at least one preventive treatment for migraine.

Exclusion Criteria:

1. History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua or new daily persistent headache;
2. Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache (MOH);
3. Current uncontrolled psychiatric or psychological condition, or one that could confound assessment of headaches/migraines or interfere with study participation;
4. Risk of self-harm or harm to others as evidenced by past suicidal behaviour or endorsing items 3, 4, or 5 on the C-SSRS at screening or Day 1.
5. Participants presenting with a swallowing disorder of any origin which might be exacerbated by botulinum toxin treatment, such as:

   \- Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing difficulties and requiring a change in diet.
6. Clinically relevant skin condition or infection that could interfere with injection of study intervention;
7. Participant has any medical condition or situation that would make them unsuitable for participation in the study;
8. Participant receiving more than one allowable concomitant migraine preventive treatment;
9. Known history of an inadequate response to \>4 medications prescribed for the prevention of migraine (2 of which have different mechanisms of action to botulinum toxin);
10. Use of any of the following medications in the specified timeframe prior to the screening visit:

    * Botulinum toxin for migraine within 24 weeks (or for any other medical/aesthetic reason within 16 weeks);
    * Prior use of mAbs blocking CGRP pathway within 12 weeks for preventative treatment of migraine
    * Prior use of oral CGRP receptor antagonist (gepants) for preventative treatment of migraine within 2 weeks;
    * Anaesthetic or steroid injection in any region targeted for treatment with study medication within 4 weeks;
    * Use of cannabidiol or other types of cannabinoids within 30 days;
    * Use of medical device to treat migraine within 4 weeks (e.g. non-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation and peripheral neuroelectrical stimulation);
    * Use of other intervention to treat migraine that is assessed to interfere with study evaluations within 4 weeks (e.g. acupuncture in the head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments and dental splints for headache);
    * Use of opioids or barbiturates for more than 2 days/month within the last 4 weeks.
11. Concurrent participation in another interventional clinical study (or within specified timeframe according to national or local legislation or requirements);
12. Diagnosis of other significant pain disorders that could confound the assessment of headaches/migraines or interfere with study participation, including but not limited to chronic pain disorders such as fibromyalgia, chronic low back pain and complex regional pain syndrome;
13. Pregnant women, nursing women, premenopausal women, or WOCBP (i.e. not surgically sterile or 1 year postmenopausal) not willing to practice an acceptable contraceptive method, at the beginning of the study and for a minimum of 12 weeks following the administration of study treatment;
14. Male subjects who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide for a minimum of 12 weeks following the initial double-blind administration of the treatment;
15. History of alcohol or drug abuse within 5 years of the screening visit (excluding medication overuse for headache);
16. Body mass index (BMI) ≥35 kg/m² at the screening visit;
17. Known clinically significant hypersensitivity to any of the study drugs, excipients or materials used to administer the study drug;
18. Patients who, in the clinician's judgment, are actively suicidal, and therefore, deemed to be at significant risk for suicide.
19. A diagnosis of a neuromuscular disorder or respiratory disorder, such as myasthenia gravis, Lambert-Eaton syndrome or amyotrophic lateral sclerosis that in the opinion of the investigator would compromise the safety of the study participant.

Where this trial is running

Birmingham, Alabama and 165 other locations

+116 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Episodic MigraineChronic Migraine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.