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 (NCT06625060)

The purpose of this study is to investigate the safety and effectiveness of IPN10200, in participants living with migraines. The information gathered from this study will contribute to our understanding of how this study treatment may benefit individuals suffering from migraines. Participants will be assigned the study drug or placebo. Following the confirmation of safety in Step 1 by the DMC, up to two doses of IPN10200 will be compared against placebo in parallel groups in Step 2. Participants who meet all study criteria will be randomly assigned to one of three intervention groups: Dose A, Dose B or a placebo. Each participant will be in the study for 40 to 44 weeks including a screening period of 6 weeks ( 2 weeks). Participants who fulfill all study criteria, will be included and will receive the study treatment at Day 1 (D1), followed by a follow up period of 36 weeks. All the participants will have to attend 7 onsite visits during the study including Screening visit, Day 1, and follow up visits at study site. Participants will also have remote visits (about 7 phone calls in total).

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Jason Ray

Key inclusion data

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.