A study to assess the long term retention on treatment and long-term safety and tolerability of Triheptanoin in male and female participants with drug-resistant epilepsy
An open-label extension study of oral Triheptanoin as an add-on treatment to adolescent and adult participants with medically refractory epilepsy
University of Queensland
12 participants
Feb 17, 2015
Interventional
Conditions
Summary
This is an open label study designed to assess the long term retention on treatment and long-term safety and tolerability of Triheptanoin in participants with drug-resistant epilepsy.
Eligibility
Plain Language Summary
Simplified for easier understanding
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
Intervention: Triheptanoin (triglyceride of heptanoate), a stable, edible tasteless oil that has been used in patients with metabolic disorders. Dose:initial dose (e.g. 15ml oil/day)the dose is escalated every week. Treated with up to 35% of caloric input triheptanoin (max 100 ml oil/day). The oil will be added to a normal diet, titrated up over 3 weeks and full dose given for a period of 48 weeks. Route: Orally three times daily (with meals) for 48 weeks During the full time of the study seizures, adverse events, side effects, weight and quality of life will be recorded. To improve adherence the participants will have regular contact with a dietitian face to face and via phone. Participants/carers will fill in a food diary and treatment diary to monitor compliance and return the used and unused bottles of oil.
Locations(1)
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ACTRN12615000406505