Tricaprilin Phase 2 Pilot Study in Migraine

NCT04437199 | Completed Phase 2 DMC

• 1 other identifier: AC-20-022
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 10

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the number of migraine headache days during Month 3 (ΔMDMth3)

  Number of migraine headache days using headache diary parameters

  12 weeks

Secondary Outcomes (4)

• 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

• 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

• Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3

  4, 8, 12 weeks

• Change from baseline Headache Impact Test (HIT-6) score at the end of Months 1, 2 and 3

  4, 8, 12 weeks

Other Outcomes (2)

• 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)

  4, 8, 12 weeks

• Change from baseline in MIDAS score at the end of Month 1, 2 and 3

  4, 8, 12 weeks

Study Arms (2)

AC-SD-03

ACTIVE COMPARATOR

Tricaprilin SD formulation, twice daily. Administered orally

Drug: Tricaprilin

AC-SD-03P

PLACEBO COMPARATOR

Placebo formulation, twice daily. Administered orally

Drug: Placebo

Interventions

Tricaprilin DRUG

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)

Also known as: AC-SD-03

AC-SD-03

Placebo DRUG

Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.

Also known as: AC-SD-03P

AC-SD-03P

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
• 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.
• Participants must have a certain number of migraine headaches days per month, as confirmed by the baseline measurement period.
• 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.
• Participants must have failed (no therapeutic response) 1-4 migraine prophylactic treatments.
• 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.
• From Visit 2 to Visit 3 (baseline measurement period), the participant has sufficient compliance (at least 80%) with daily eDiary headache entries.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Cerecin: lead

Study Sites (10)

Paratus Clinical Central Coast

Kanwal, New South Wales, 2259, Australia

Location

Holdsworth House

Sydney, New South Wales, 2010, Australia

Location

Calvary Adelaide Hospital

Adelaide, Australia

Location

Paratus Clinical Research Western Sydney

Blacktown, Australia

Location

Paratus Clinical Research Brisbane

Brisbane, Australia

Location

Emeritus Research

Camberwell, Australia

Location

Paratus Clinical Research Canberra

Canberra, Australia

Location

Austin Health Hospital

Heidelberg, Australia

Location

Alfred Health Hospital

Melbourne, Australia

Location

Gold Coast University Hospital

Southport, Australia

Location

Related Publications (1)

• Chow L, Presanis J, McIntyre N, Henderson S, Bloch M, Hutton E, Cantillon M. Tricaprilin (CER-0001) for the preventive treatment of migraine: A phase 2 randomised, double-blind, placebo-controlled pilot study. J Neurol Sci. 2024 Sep 15;464:123147. doi: 10.1016/j.jns.2024.123147. Epub 2024 Jul 22.

  PMID: 39094432 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

tricaprylin

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Study Director

  Cerecin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 18, 2020
• Study Start: December 17, 2020
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (10)