Tricaprilin Phase 2 Pilot Study in Migraine

Phase 2

Completed

• Conditions: Migraine
• Interventions: Drug: Placebo; Drug: Tricaprilin

• Registration Number: NCT04437199
• Lead Sponsor: Cerecin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-18
• Study Start: 2020-12-17
• Primary Completion: 2022-02-07
• Study Completion: 2022-02-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AC-SD-03P	Placebo	Placebo formulation, twice daily. Administered orally
AC-SD-03	Tricaprilin	Tricaprilin SD formulation, twice daily. Administered orally

Primary Outcome Measures

Name	Time	Method
Change from baseline in the number of migraine headache days during Month 3 (ΔMDMth3)	12 weeks	Number of migraine headache days using headache diary parameters

Secondary Outcome Measures

Name	Time	Method
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	4, 8, 12 weeks	Number of migraine headache days using headache diary parameters
Change from baseline Headache Impact Test (HIT-6) score at the end of Months 1, 2 and 3	4, 8, 12 weeks	Headache Impact Test (HIT-6) score. Total score range between 36-78 (higher score indicates a worse impact)
Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3	4, 8, 12 weeks	Acute migraine medicine use during treatment
The proportion of participants with a 50% reduction from baseline in number of migraine headache days in treatment months 1, 2, and 3	4, 8, 12 weeks	Response rate defined as a reduction in number of migraine headache days

Trial Locations

Locations (10)

Holdsworth House; 🇦🇺 Sydney, New South Wales, Australia

Calvary Adelaide Hospital; 🇦🇺 Adelaide, Australia

Paratus Clinical Research Canberra; 🇦🇺 Canberra, Australia

Paratus Clinical Research Brisbane; 🇦🇺 Brisbane, Australia

Paratus Clinical Central Coast; 🇦🇺 Kanwal, New South Wales, Australia

Alfred Health Hospital; 🇦🇺 Melbourne, Australia

Emeritus Research; 🇦🇺 Camberwell, Australia

Austin Health Hospital; 🇦🇺 Heidelberg, Australia

Paratus Clinical Research Western Sydney; 🇦🇺 Blacktown, Australia

Gold Coast University Hospital; 🇦🇺 Southport, Australia