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Tricaprilin Phase 2 Pilot Study in Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04437199
Recruitment Status : Completed
First Posted : June 18, 2020
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Tricaprilin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : December 17, 2020
Actual Primary Completion Date : February 7, 2022
Actual Study Completion Date : February 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Active Comparator: AC-SD-03
Tricaprilin SD formulation, twice daily. Administered orally
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)

Other Name: AC-SD-03

Placebo Comparator: AC-SD-03P
Placebo formulation, twice daily. Administered orally
Drug: Placebo
Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
Other Name: AC-SD-03P




Primary Outcome Measures :
  1. Change from baseline in the number of migraine headache days during Month 3 (ΔMDMth3) [ Time Frame: 12 weeks ]
    Number of migraine headache days using headache diary parameters


Secondary Outcome Measures :
  1. 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 [ Time Frame: 4, 8, 12 weeks ]
    Number of migraine headache days using headache diary parameters

  2. The proportion of participants with a 50% reduction from baseline in number of migraine headache days in treatment months 1, 2, and 3 [ Time Frame: 4, 8, 12 weeks ]
    Response rate defined as a reduction in number of migraine headache days

  3. Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3 [ Time Frame: 4, 8, 12 weeks ]
    Acute migraine medicine use during treatment

  4. Change from baseline Headache Impact Test (HIT-6) score at the end of Months 1, 2 and 3 [ Time Frame: 4, 8, 12 weeks ]
    Headache Impact Test (HIT-6) score. Total score range between 36-78 (higher score indicates a worse impact)


Other Outcome Measures:
  1. 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) [ Time Frame: 4, 8, 12 weeks ]
    Headache diary parameters

  2. Change from baseline in MIDAS score at the end of Month 1, 2 and 3 [ Time Frame: 4, 8, 12 weeks ]
    Migraine Disability Assessment Scale (MIDAS) score. Total score range between 0-28 (higher score indicates more severe disability)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437199


Locations
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Australia, New South Wales
Paratus Clinical Central Coast
Kanwal, New South Wales, Australia, 2259
Holdsworth House
Sydney, New South Wales, Australia, 2010
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
Alfred Health Hospital
Melbourne, Australia
Gold Coast University Hospital
Southport, Australia
Sponsors and Collaborators
Cerecin
Investigators
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Study Director: Study Director Cerecin
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Responsible Party: Cerecin
ClinicalTrials.gov Identifier: NCT04437199    
Other Study ID Numbers: AC-20-022
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases