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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIpsen

About this trial

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.

Eligibility criteria

Qualifiers

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;

Male or female ≥18 to 80 years of age at the time of signing the informed consent;

Diagnosis of either EM or CM, per ICHD-3 criteria, for at least 12 months prior to the screening visit;

Diagnosis of migraine at ≤50 years of age;

Disqualifiers

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;

Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache (MOH);

Current uncontrolled psychiatric or psychological condition, or one that could confound assessment of headaches/migraines or interfere with study participation;

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.

Trial design

Treatments tested in this trial

  • IPN10200
  • Placebo
  • IPN10200 dose A
  • IPN10200 dose B

Treatment groups

641 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Locations

166
Australia
The Alfred Hospital - Neurology Melbourne Australia
Western Health - Neurology & Stroke Services Saint Albans Australia
The Royal Melbourne Hospital - Neurology Victoria Park Australia
Brazil
Instituto de Neurologia de Curitiba Paraná Brazil

Sponsors and collaborators

Ipsen

Lead sponsor