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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-SD-03 | Active Comparator | Tricaprilin SD formulation, twice daily. Administered orally |
|
| AC-SD-03P | Placebo Comparator | Placebo formulation, twice daily. Administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Headache diary parameters | 4, 8, 12 weeks |
| Change from baseline in MIDAS score at the end of Month 1, 2 and 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Cerecin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paratus Clinical Central Coast | Kanwal | New South Wales | 2259 | Australia | ||
| Holdsworth House |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39094432 | Derived | 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. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C003637 | tricaprylin |
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|
| Placebo | Drug | Powder formulation will be mixed with 240 mL water and shaken until fully dispersed. |
|
|
Response rate defined as a reduction in number of migraine headache days |
| 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 | 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) | 4, 8, 12 weeks |
Migraine Disability Assessment Scale (MIDAS) score. Total score range between 0-28 (higher score indicates more severe disability) |
| 4, 8, 12 weeks |
| Sydney |
| New South Wales |
| 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 |
| D009422 | Nervous System Diseases |