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A Study of Corabotase for Migraine Prevention

This study is testing Corabotase (also known as IPN10200) to see if it can safely and effectively prevent episodic or chronic migraines in adults. Corabotase works by stopping the release of chemicals in the brain that cause migraine pain. The study will involve adults aged 18 to 80 who experience either episodic migraine (migraines less than 15 days a month) or chronic migraine (migraines 15 or more days a month). Researchers will be looking at how many participants experience side effects (adverse events) and how their lab tests and vital signs (like blood pressure) change over 36 weeks. The study status is currently unclear, and it plans to enroll 641 participants.

Study design
This interventional study involves two steps, testing different doses of Corabotase or a placebo (a substance with no active medicine). Participants will be randomly assigned to receive either Corabotase or placebo, given as injections into muscles in the head, face, and neck.
What's involved
You would first go through a screening period to see if you can join. If eligible, you would receive injections and be monitored for safety and effectiveness until a visit at Week 36.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for 36 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06625060

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

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Ipsen
~641 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:CorabotasePlaceboCorabotase dose ACorabotase dose B

At a glance

Recruiting sites
111 of 166 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants experiencing any Adverse Event (AEs) including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse event of special interest (AESI) and AE leading to treatment discontinuation
Measured over For step 1: From baseline until end of study at Week 36
+8 more outcomes measured

Conditions

Episodic Migraine
Chronic Migraine

Explore related trials

Chronic MigraineEpisodic migraine

Where it's being run

166 sites across 35 states
Poland17
California15
Japan11
Germany10
Florida8
Georgia7
Czechia7
New Zealand7

Study leadership

  • Ipsen Medical Director · STUDY_DIRECTOR · Ipsen

Who to contact

Ipsen Clinical Study Enquiries
[email protected]
See e mail
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Percentage of participants experiencing any Adverse Event (AEs) including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse event of special interest (AESI) and AE leading to treatment discontinuationFor step 1: From baseline until end of study at Week 36

    An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.

  • Percentage of Participants with clinically significant changes from baseline in Laboratory ParametersFor step 1: At all timepoints post injection until Week 36

    Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator.

  • Percentage of Participants With Clinically Significant Changes from baseline in Vital SignsFor step 1: At all timepoints post injection until Week 36

    Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.

  • Percentage of participants with clinically significant change from baseline in facial examinationFor step 1: At all timepoints post injection until Week 36

    Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.

  • Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readingsFor step 1: At all timepoints post injection until Week 36
  • Treatment-emergence of suicidal ideation/suicidal behaviourFor step 1: At all timepoints post injection until Week 36

    It will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire that consists of 2 subscales: 1. Ideation severity subscale: questions answered yes/no, severity of ideation scored 1-5 with 5 being most severe 2. Intensity of ideation subscale : scores range from 2-25 with higher scores indicating more severe intensity of ideation.

  • Percentage of participants with Binding antibodies to IPN10200For step 1: At baseline, Week 4, Week 12 and Week 36.
  • Percentage of participants with neutralising antibodies to IPN10200For step 1: At baseline, Week 4, Week 12 and Week 36.
  • Change from baseline in the number of Monthly migraine days (MMD)sFor step 2: At Week 12 (Weeks 9-12).