EpiCom
Research type
Research Study
Full title
A Phase 4, Interventional, Multicenter Open-Label, Single-Arm Study to Assess Behavioral and Other Co-occurring Outcomes Following Treatment With EPID(I/Y)OLEX as Add-on Therapy in Participants (Aged 1 to 65 Years Old) With Seizures Associated With Tuberous Sclerosis Complex (EpiCom)
IRAS ID
1007156
Contact name
Lisa Moore-Ramdin
Contact email
Sponsor organisation
GW Research Ltd
Research summary
In addition to seizures, tuberous sclerosis complex (TSC) is often associated with behavioral, cognitive, and neuropsychiatric symptoms (referred to as TSC Associated Neuropsychiatric Disorders, or TAND), which are likely to place a heavy burden on patients, as well as their caregivers and families.
The Sponsor is doing this trial to find out whether EPID(I/Y)OLEX is safe and works in improving quality of life, sleep, mood and other symptoms associated in patients with TSC who experience seizures.
Approximately 75 people aged between 1 and 65 years old who have TSC and experience seizures will take part in this trial. Patients will be recruited from the United Kingdom (aged 2 - 65) and also elsewhere in the world including United States (aged 1-65). Each participant will be in the study for up to 62 weeks and will attend up to 9 visits during the study.
Participants will receive the trial drug, Epidyolex, twice daily during the treatment period (up to a maximum of 56 weeks). There will be medical reviews, blood and urine samples will be taken, and a number of questionnaires will be completed.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0136
Date of REC Opinion
29 Aug 2023
REC opinion
Further Information Favourable Opinion