CompletedPhase 2ACTRN12612000226808

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

Sponsor

University of Queensland

Enrollment

60 participants

Start Date

Jul 30, 2012

Study Type

Interventional

Conditions

Medical refractory epilepsy

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

Sex: Both males and femalesMin Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests oral triheptanoin (a dietary fat supplement) as an add-on treatment for patients aged 12 and older with drug-resistant epilepsy who experience at least 4 seizures per month despite taking anti-epileptic medication. The research evaluates whether this supplement can reduce seizure frequency when added to existing medications. Patients must be on stable anti-epileptic drugs for at least 4 weeks before enrolling.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

VIC, Australia

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ACTRN12612000226808