A safety and feasibility study of oral Triheptanoin as an add on treatment for patients (12 years or older) with medical refractory epilepsy.

Phase 2

Completed

• Conditions: Medical refractory epilepsy; Neurological - Epilepsy

• Registration Number: ACTRN12612000226808
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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 Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety. Possible adverse events include gastrointestinal upset and diarrhoea.[Monitored weekly during 3 week titration period and then four weekly over the 16 week treatment period. Safety will be assessed based on reported adverse events.]

Secondary Outcome Measures

Name	Time	Method
Complience with treatment[Will be monitored weekly during the titration period and then 4 weekly during the 16 week treatment period. Complience will be assessed by amount of oil returned at each study visit.];Tolerability of treatment[Will be monitored weekly during the titration period and then 4 weekly during the 16 wekk treatment period. Tolerability will be assessed based on discussions with the patient, assessment of the food diary and assessment of adverse events.]