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
Summary
Meranti is a multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of IPN10200 in the prevention of episodic or chronic migraine in adults with episodic (EM) or chronic migraine (CM).
Eligibility
Eligible ages: 18 to 80
Accepts healthy participants: Yes
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.
Participate
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Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
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Additional information
Contact information
Study recruitment by physician referral. Prospective participants can connect with study team to express their interest and for further details about the study and potential study participation. CHAMP (Calgary Headache Assessment & Management Program) Research Office Outpatient Neurology, 5th Floor Clinic 5E South Health Campus
Principal investigator:
Prin Chitsantikul
Clinical trial:
Yes
REB-ID:
REB25-1034