Meranti Study: 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

Conditions de participation

• Sexe:

  Male, Female, Intersex

• Âges admissibles:

  18 to 80

Critères de participation

Inclusion Criteria:
1. ≥18 to 80 years of age (at time of signing informed consent).
2. Diagnosed at ≤50 years of age and ≥12 months prior to Screening with either episodic migraine (EM) or (CM) (per ICHD-3* criteria).
3. Prior to Screening for the study, previous use (for a period of ≥8 weeks) of ≥1 preventive treatment for migraine.
4. In the 4 weeks prior to study visit 2 (the randomization visit):
For EM group – headache frequency of ≤14 headache days, migraine frequency of ≥6 migraine days.
For CM group – headache frequency of ≥15 headache days, migraine frequency of ≥8 migraine days.
Exclusion Criteria:
1. No swallowing disorder of any origin that may be exacerbated by botulinum toxin treatment.
2. Participant receiving more than one allowable migraine preventive treatment, currently.
3. History of an inadequate response to >4 migraine preventive treatments.
4. Body mass index (BMI) ≥35 kg/m² at the screening visit.