Clinical trial NCT04437199: Tricaprilin Phase 2 Pilot Study in Migraine
Official title: A 12-Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Participants With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of tricaprilin as AC-SD-03 compared with placebo for the reduction of migraine in participants with frequent migraine.


Eligibility criteria: Inclusion Criteria:

1. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
2. Participants who have frequent (episodic or chronic) migraine with or without aura, for at least 1 year, according to the International Classification of Headache Disorders version 3 beta (ICHD 3-beta), age at time of onset must be \<50 years.
3. Participants must have a certain number of migraine headaches days per month, as confirmed by the baseline measurement period.
4. Use of one allowed migraine prophylactic is permitted if the participant has been on a stable dose for at least 2 months prior to the screening.
5. Participants must have failed (no therapeutic response) 1-4 migraine prophylactic treatments.
6. The participant is able to tolerate a 12.5g dose of AC-SD-03 (containing 5g of tricaprilin) as per sentinel dose challenge at the Baseline Visit.
7. From Visit 2 to Visit 3 (baseline measurement period), the participant has sufficient compliance (at least 80%) with daily eDiary headache entries.

Exclusion Criteria:

1. In the opinion of the Investigator, has presence or history of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments, or put the participant at risk.
2. Use of barbiturates (and/or butalbital-containing analgesics) or opioids (and/or opioid-containing analgesics) for migraine acute treatment ≥ 4 days per month on average and/or in the last month prior to Screening Visit.
3. Use in the last 3 months prior to Screening Visit of CGRP agents, Botox injections, TENS, cranial nerve blocks, trigger-point injections, acupuncture, CBD-containing products, infusion therapy.
4. Current use, or use within 3 months of Visit 2 (baseline), of Axona® or other MCT-containing products (such as coconut oil). Use of MCT-containing products is not allowed at any time during trial participation.
5. Current use, or use within 3 months prior to Screening, of a ketogenic diet, low-carb diet, intermittent fasting (including the 5:2 diet). Ketogenic diets, low-carb diet, intermittent fasting (including the 5:2 diet) are not allowed during the study.

Primary outcomes:
measure: Change from baseline in the number of migraine headache days during Month 3 (ΔMDMth3)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in the number of migraine headache days during Month 1 (ΔMDMth1) and Month 2 (ΔMDMth2) of treatment and overall, from Months 1-3
timeFrame: 4, 8, 12 weeks
measure: The proportion of participants with a 50% reduction from baseline in number of migraine headache days in treatment months 1, 2, and 3
timeFrame: 4, 8, 12 weeks
measure: Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3
timeFrame: 4, 8, 12 weeks
measure: Change from baseline Headache Impact Test (HIT-6) score at the end of Months 1, 2 and 3
timeFrame: 4, 8, 12 weeks
Other outcomes:
measure: Change from baseline in the number of headache days (migraine and non-migraine headache) during treatment months 1, 2 and 3 (ΔHDMth1, ΔHDMth2 and ΔHDMth3)
timeFrame: 4, 8, 12 weeks
measure: Change from baseline in MIDAS score at the end of Month 1, 2 and 3
timeFrame: 4, 8, 12 weeks
Locations:
city: Kanwal
country: Australia
facility: Paratus Clinical Central Coast
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House
state: New South Wales
city: Adelaide
country: Australia
facility: Calvary Adelaide Hospital
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney
city: Brisbane
country: Australia
facility: Paratus Clinical Research Brisbane
city: Camberwell
country: Australia
facility: Emeritus Research
city: Canberra
country: Australia
facility: Paratus Clinical Research Canberra
city: Heidelberg
country: Australia
facility: Austin Health Hospital
city: Melbourne
country: Australia
facility: Alfred Health Hospital
city: Southport
country: Australia
facility: Gold Coast University Hospital
Study officials:
affiliation: Cerecin
name: Study Director
role: STUDY_DIRECTOR
References: