Participants Needed for Epilepsy Drug Trial
March 26, 2019
UH Clinical Update - March 2019
Asim Shahid, MD, pediatric epilepsy specialist at UH Rainbow Babies & Children's Hospital, is seeking participants for the FAiRE (Fenfluramine Assessment in Rare Epilepsy) LGS study. This a multi-center, double-blind, placebo-controlled clinical trial to evaluate whether an investigational drug, ZX008 (Fenfluramine Hydrochloride, oral solution), when taken in addition to current anti-epileptic treatments, can reduce the number of seizures that result in drops experienced by children and adults with Lennox-Gastaut syndrome, a rare form of epilepsy.
To take part in the FAiRE research study, participants must:
- Meet the diagnostic criteria for LGS with no alternative diagnosis
- Be between 2 and 35 years of age
- Have uncontrolled seizures despite current medications
- Be receiving stable doses of medications that are not being changed during the study
The FAiRE-LGS study is divided into 2 parts:
- In Part 1, participants have a 67 percent chance of receiving study drug and a 33 percent chance of receiving placebo.
- In Part 2, all participants will receive the investigational drug.
Part 1 will last for approximately 20 weeks and includes six office visits and six phone calls. Part 2 will last for up to 54 weeks and include approximately seven office visits and one phone call.
Participants that complete the study, even if only participating in Part 1, will also be asked to come in for a follow-up visit a couple of weeks after the last dose is taken, and then additional cardiac safety follow-up visits in the months after receiving the last dose of study medication.
During clinic visits, the study team will perform a range of assessments and laboratory tests. These will differ from visit to visit but may include:
- Vital signs checks
- Blood tests
- Physical examinations
- Nervous system assessments
- Questionnaires about cognition, behavior, quality of life
Participants will be expected to take study medication twice a day and to complete the electronic diary every day during the study, and to bring this diary to each visit.