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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000226808

Acronym

TRIP - E

Enrollment

Registered

2012-02-22

Start date

2012-07-30

Completion date

2015-03-06

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 seizur

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Healthy volunteers

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.

Outcome results