03 July 2023 | Monday | News
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The data will be used to inform future studies. The study's findings were highlighted in a poster presentation at the 65th Annual Society Meeting of the American Headache Society, held in Austin, Texas from June 15-18, 2023. The poster was presented by Cerecin's Chief Medical Officer, Dr. Marc Cantillon. The poster was entitled, Metabolic Mechanism in Migraine: Tricaprilin, a Ketogenic Agent.
The RELIEF study was a double-blind, randomized, placebo-controlled, 3-month study of up to 60 g/day tricaprilin. The primary endpoint was the change from baseline in the number of migraine headache days (MHDs) during month three. Eligible participants had 4-24 MHDs in the baseline period. The study was registered on clinicaltrials.gov (NCT04437199). The primary endpoint was not met due to lack of statistical power, however, an efficacy signal was noted in sensitivity analyses. Some patients opted to enter the CER-0001 Compassionate Access Program which provides continued access to CER-0001 (tricaprilin) for up to one year after completion of the clinical study.
Given that metabolic factors have been implicated in migraine etiology, the induction of ketosis via ketogenic drugs like tricaprilin could potentially offer an innovative approach to managing this condition. Professor Mark Bloch, Associate Professor at University of New South Wales, Sydney and RELIEF study investigator commented, "It is important that the headache field is aware of development of novel mechanism drugs, such as tricaprilin. This metabolism-based option is promising and should continue in development as a possible future treatment option."
The RELIEF study's preliminary findings support the further study of the investigational drug tricaprilin as a preventive treatment for migraines and affirm Cerecin's commitment to exploring cutting-edge therapeutics in the field of neurology.