None listed
Conditions
Brief 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.
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 seizur
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.
Sponsors
University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
TRIP-E study (ACTRN12612000226808) for cross referencing purposes 1. Participants randomised in the TRIP-E study and who finished the treatment period with appropriate compliance with diet and study procedures. 2. Ability to give informed consent (Participant, parent or person responsible) 3. Females of childbearing potential must have a negative serum betahCG at Visit 1 and either abstain or use acceptable contraception for the duration of the trial.
Exclusion criteria
1. Participants with a severe intellectual handicap 2. History of major psychiatric morbidity (such as psychiatric illness requiring hospitalisation or history of psychosis or major depression) 3. Participants with history of substance abuse, eating disorders or irritable bowel syndrome 4. Females who are pregnant or breast feeding 5. Participants with disorders affecting medium and short chain fatty acid oxidation.
Outcome results
None listed