A safety and feasibility study of oral Triheptanoin as an add on treatment for patients (12 years or older) with medical refractory epilepsy.
A Phase IIa randomized double-blind placebo controlled study to evaluate the safety and feasibility of oral triheptanoin as an add-on treatment to adolescent and adult patients with medically refractory epilepsy
University of Queensland
60 participants
Jul 30, 2012
Interventional
Conditions
Summary
A study to determine the safety, tolerability and complience tripheptanoin oil, taken as an oral supplement by patients 12 years and older, who have medical refractory epilepsy.
Eligibility
Inclusion Criteria2
- Male or female patients (12 years or older) with epilepsy who have experienced at least 4 seizures of an eligible type per month over two months prior to enrolment despite treatment with at least one anti-epileptic drug at clinically appropriate doses. (Eligible seizure types are: complex partial seizures (focal dyscognitive seizures), secondary generalised seizures, simple partial seizures with motor features, primary generalised seizures, tonic seizures, atonic seizures) Patients anti-epileptic drugs over the four weeks prior to enrolment must remain stable with no change.
- Patients must be able to provide informed consent.
Exclusion Criteria7
- Patients with a severe intellectual handicap
- Patients with a history of major psychiatric morbidity (such as psychiatric illness requiring hospitalisation or history of psychosis or major depression)
- Patients with history of substance abuse
- Patients with a history of having had psychogenic non-epileptic seizures
- Patients who have seizure clusters or other reasons that make counting of numbers of seizures inaccurate
- Females who are pregnant or breast feeding
- Patients with disorders affecting medium and short chain fatty acid oxidation. This includes medium-chain acyl-CoA dehydrogenase deficiency - MCAD, short-chain acyl-CoA dehydrogenase deficiency - SCAD, short-chain-3 hydroxyacyl-CoA dehydrogenase deficiency –SCHAD and HMG CoA (3-hydroxy-3-methyl-glutaryl-CoA) synthase deficiency.
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Interventions
The patient will be up titrated to a maximum tolerated dose of Triheptanoin during a three week titration period. (Start dose 15 ml) The total daily dose will be between 15 and 100ml daily depending on the patients tolerability (Up to 35% of caloric input per day). Patients will be take the maximum tolerated dose over a period of 16 weeks and assessed during this time. Patients will take Triheptanoin orally three to four times per day with meals. They will be asked to complete a food and seizure diary
Locations(1)
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ACTRN12612000226808