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Tricaprilin Phase 2 Pilot Study in Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Tricaprilin
Placebo
Sponsored by
Cerecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Paratus Clinical Central Coast
  • Holdsworth House
  • Calvary Adelaide Hospital
  • Paratus Clinical Research Western Sydney
  • Paratus Clinical Research Brisbane
  • Emeritus Research
  • Paratus Clinical Research Canberra
  • Austin Health Hospital
  • Alfred Health Hospital
  • Gold Coast University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AC-SD-03

AC-SD-03P

Arm Description

Tricaprilin SD formulation, twice daily. Administered orally

Placebo formulation, twice daily. Administered orally

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Number of migraine headache days using headache diary parameters
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
Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3
Acute migraine medicine use during treatment
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)

Full Information

First Posted
June 11, 2020
Last Updated
August 18, 2022
Sponsor
Cerecin
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1. Study Identification

Unique Protocol Identification Number
NCT04437199
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
February 7, 2022 (Actual)
Study Completion Date
February 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerecin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AC-SD-03
Arm Type
Active Comparator
Arm Description
Tricaprilin SD formulation, twice daily. Administered orally
Arm Title
AC-SD-03P
Arm Type
Placebo Comparator
Arm Description
Placebo formulation, twice daily. Administered orally
Intervention Type
Drug
Intervention Name(s)
Tricaprilin
Other Intervention Name(s)
AC-SD-03
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
AC-SD-03P
Intervention Description
Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
Primary Outcome Measure Information:
Title
Change from baseline in the number of migraine headache days during Month 3 (ΔMDMth3)
Description
Number of migraine headache days using headache diary parameters
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
Description
Number of migraine headache days using headache diary parameters
Time Frame
4, 8, 12 weeks
Title
The proportion of participants with a 50% reduction from baseline in number of migraine headache days in treatment months 1, 2, and 3
Description
Response rate defined as a reduction in number of migraine headache days
Time Frame
4, 8, 12 weeks
Title
Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3
Description
Acute migraine medicine use during treatment
Time Frame
4, 8, 12 weeks
Title
Change from baseline Headache Impact Test (HIT-6) score at the end of Months 1, 2 and 3
Description
Headache Impact Test (HIT-6) score. Total score range between 36-78 (higher score indicates a worse impact)
Time Frame
4, 8, 12 weeks
Other Pre-specified Outcome Measures:
Title
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)
Description
Headache diary parameters
Time Frame
4, 8, 12 weeks
Title
Change from baseline in MIDAS score at the end of Month 1, 2 and 3
Description
Migraine Disability Assessment Scale (MIDAS) score. Total score range between 0-28 (higher score indicates more severe disability)
Time Frame
4, 8, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Cerecin
Official's Role
Study Director
Facility Information:
Facility Name
Paratus Clinical Central Coast
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2259
Country
Australia
Facility Name
Holdsworth House
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Calvary Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Paratus Clinical Research Western Sydney
City
Blacktown
Country
Australia
Facility Name
Paratus Clinical Research Brisbane
City
Brisbane
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
Country
Australia
Facility Name
Paratus Clinical Research Canberra
City
Canberra
Country
Australia
Facility Name
Austin Health Hospital
City
Heidelberg
Country
Australia
Facility Name
Alfred Health Hospital
City
Melbourne
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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Tricaprilin Phase 2 Pilot Study in Migraine

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