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

Phase 2

Completed

• Conditions: Medically refractory epilepsy; Neurological - Epilepsy

• Registration Number: ACTRN12615000406505
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified