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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04437199




Registration number
NCT04437199
Ethics application status
Date submitted
11/06/2020
Date registered
18/06/2020

Titles & IDs
Public title
Tricaprilin Phase 2 Pilot Study in Migraine
Scientific 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
Secondary ID [1] 0 0
AC-20-022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tricaprilin
Treatment: Drugs - Placebo

Active comparator: AC-SD-03 - Tricaprilin SD formulation, twice daily. Administered orally

Placebo comparator: AC-SD-03P - Placebo formulation, twice daily. Administered orally


Treatment: Drugs: 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)

Treatment: Drugs: Placebo
Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in the number of migraine headache days during Month 3 (?MDMth3)
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
4, 8, 12 weeks
Secondary outcome [2] 0 0
The proportion of participants with a 50% reduction from baseline in number of migraine headache days in treatment months 1, 2, and 3
Timepoint [2] 0 0
4, 8, 12 weeks
Secondary outcome [3] 0 0
Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3
Timepoint [3] 0 0
4, 8, 12 weeks
Secondary outcome [4] 0 0
Change from baseline Headache Impact Test (HIT-6) score at the end of Months 1, 2 and 3
Timepoint [4] 0 0
4, 8, 12 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/02/2022
Sample size
Target
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Paratus Clinical Central Coast - Kanwal
Recruitment hospital [2] 0 0
Holdsworth House - Sydney
Recruitment hospital [3] 0 0
Calvary Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [5] 0 0
Paratus Clinical Research Brisbane - Brisbane
Recruitment hospital [6] 0 0
Emeritus Research - Camberwell
Recruitment hospital [7] 0 0
Paratus Clinical Research Canberra - Canberra
Recruitment hospital [8] 0 0
Austin Health Hospital - Heidelberg
Recruitment hospital [9] 0 0
Alfred Health Hospital - Melbourne
Recruitment hospital [10] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
2259 - Kanwal
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Blacktown
Recruitment postcode(s) [5] 0 0
- Brisbane
Recruitment postcode(s) [6] 0 0
- Camberwell
Recruitment postcode(s) [7] 0 0
- Canberra
Recruitment postcode(s) [8] 0 0
- Heidelberg
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment postcode(s) [10] 0 0
- Southport

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cerecin
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Cerecin
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04437199