Tricaprilin Phase 2 Pilot Study in Migraine

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437199
• Other study ID #: AC-20-022
• Status: Completed
• Phase: Phase 2
• Start date: December 17, 2020
• Est. completion date: February 7, 2022

Study information

• Verified date: February 2024
• Source: Cerecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 7, 2022
• Est. primary completion date: February 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Tricaprilin
Powder formulation will be mixed with 240 mL water and shaken until fully dispersed. Each dosing unit of 12.5 g of AC-SD-03 contains 5 g of the active ingredients (tricaprilin)
• Placebo
Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.

Locations

Country	Name	City	State
Australia	Calvary Adelaide Hospital	Adelaide
Australia	Paratus Clinical Research Western Sydney	Blacktown
Australia	Paratus Clinical Research Brisbane	Brisbane
Australia	Emeritus Research	Camberwell
Australia	Paratus Clinical Research Canberra	Canberra
Australia	Austin Health Hospital	Heidelberg
Australia	Paratus Clinical Central Coast	Kanwal	New South Wales
Australia	Alfred Health Hospital	Melbourne
Australia	Gold Coast University Hospital	Southport
Australia	Holdsworth House	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Cerecin

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in the number of headache days (migraine and non-migraine headache) during treatment months 1, 2 and 3 (?HDMth1, ?HDMth2 and ?HDMth3)	Headache diary parameters	4, 8, 12 weeks
Other	Change from baseline in MIDAS score at the end of Month 1, 2 and 3	Migraine Disability Assessment Scale (MIDAS) score. Total score range between 0-28 (higher score indicates more severe disability)	4, 8, 12 weeks
Primary	Change from baseline in the number of migraine headache days during Month 3 (?MDMth3)	Number of migraine headache days using headache diary parameters	12 weeks
Secondary	Change from baseline in the number of migraine headache days during Month 1 (?MDMth1) and Month 2 (?MDMth2) of treatment and overall, from Months 1-3	Number of migraine headache days using headache diary parameters	4, 8, 12 weeks
Secondary	The proportion of participants with a 50% reduction from baseline in number of migraine headache days in treatment months 1, 2, and 3	Response rate defined as a reduction in number of migraine headache days	4, 8, 12 weeks
Secondary	Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3	Acute migraine medicine use during treatment	4, 8, 12 weeks
Secondary	Change from baseline Headache Impact Test (HIT-6) score at the end of Months 1, 2 and 3	Headache Impact Test (HIT-6) score. Total score range between 36-78 (higher score indicates a worse impact)	4, 8, 12 weeks