Safety, Tolerability, and Efficacy of RLS103 in a Clinical Model of Photosensitive Epilepsy (NCT05678881) | Clinical Trial Compass
TerminatedPhase 1
Safety, Tolerability, and Efficacy of RLS103 in a Clinical Model of Photosensitive Epilepsy
Stopped: Lack of enrollment
2 participantsStarted 2022-04-25
Plain-language summary
The purpose of this study is to evaluate RLS103 for safety and suppression of the epileptic photoparoxysmal response compared to placebo.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Must sign an informed consent form (ICF) indicating that they understand the purpose of the study and the procedures required for the study; and are willing to participate in the study and attend all visits and requirements.
* Individuals age 18-65 years, inclusive.
* A history of a photoparoxysmal response on EEG with or without a diagnosis of epilepsy for which subjects are on 0-3 concomitant antiseizure medications (ASMs).
* At least 3 of the EEGs performed during the Screening Visit must have a reproducible IPS-induced photoparoxysmal response (PPR) on EEG of ≥3 points on a frequency assessment scale in the same eye condition.
* Subjects in otherwise good health (with the exception of epilepsy), as determined by the PI via the medical history, a physical examination and screening laboratory investigations.
* A body mass index (BMI) between 17.5 to 42
* Participants agree to refrain from strenuous exercise the day before Screening and during the day prior to treatment days.
* Females of childbearing potential must commit to the consistent and correct use of an effective method of birth control throughout the study and must also have negative pregnancy test results at all visits prior to investigational product (IP) administration. Effective methods of contraception include surgical sterilization of the subject, condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contrace…