MigrainePhase 2NCT04437199
Tricaprilin Phase 2 Pilot Study in Migraine
A Phase 2 study testing Tricaprilin in people with Migraine, run by Cerecin at 10 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine
- What is being tested?
- Tricaprilin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 10 sitesAustralia
- Study dates
- 17 Dec 2020to 7 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Australia10 sites
Calvary Adelaide Hospital
Adelaide
Paratus Clinical Research Western Sydney
Blacktown
Paratus Clinical Research Brisbane
Brisbane
Emeritus Research
Camberwell
Paratus Clinical Research Canberra
Canberra
Austin Health Hospital
Heidelberg
Paratus Clinical Central Coast
Kanwal, New South Wales, 2259
Alfred Health Hospital
Melbourne
Gold Coast University Hospital
Southport
Holdsworth House
Sydney, New South Wales, 2010
About this study
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
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
- Being tested
- Tricaprilin, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TricaprilinDrug
Also called AC-SD-03
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)
PlaceboDrug
Also called AC-SD-03P
Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
| Study group | Role | What they receive |
|---|---|---|
| AC-SD-03 | Active comparator | Tricaprilin SD formulation, twice daily. Administered orally Receives: Drug: Tricaprilin |
| AC-SD-03P | Placebo comparator | Placebo formulation, twice daily. Administered orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the number of migraine headache days during Month 3 (ΔMDMth3)
Number of migraine headache days using headache diary parameters
Measured: 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
Number of migraine headache days using headache diary parameters
Measured: 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
Response rate defined as a reduction in number of migraine headache days
Measured: 4, 8, 12 weeks
Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3
Acute migraine medicine use during treatment
Measured: 4, 8, 12 weeks
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)
Measured: 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start17 Dec 2020
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerecin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Cerecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437199
- Sponsor's protocol ID
- AC-20-022
- Status last verified
- Feb 2024
- First submitted
- 11 Jun 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39094432
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04437199
- Acronym / sponsor ID
- AC-20-022
- Conditions
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC-SD-03 | Active comparator | Drug: TricaprilinTricaprilin SD formulation, twice daily. Administered orally |
| AC-SD-03P | Placebo comparator | Drug: PlaceboPlacebo formulation, twice daily. Administered orally |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TricaprilinAlso: AC-SD-03Powder 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) | Drug | AC-SD-03 |
| PlaceboAlso: AC-SD-03PPowder formulation will be mixed with 240 mL water and shaken until fully dispersed. | Drug | AC-SD-03P |
Primary outcome
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
4 secondary outcomes
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
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
Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3
Time frame: 4, 8, 12 weeks
Change from baseline Headache Impact Test (HIT-6) score at the end of Months 1, 2 and 3
Time frame: 4, 8, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 39094432Chow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Cerecin
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tricaprilin in people with Migraine, run by Cerecin at 10 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the number of migraine headache days during Month 3 (ΔMDMth3) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04437199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.