A Double-Blind, Placebo-Controlled Crossover Study of NPT 2042 in People Aged 16 to 75 With Genetic Generalized Epilepsy and Absence Seizures

What this Trial Is About

Researchers are evaluating the effects of NPT 2042, a new anti-seizure drug, compared with placebo in people aged 16 to 75 years who have genetic generalized epilepsy GGE with absence seizures. This study aims to measure how these treatments affect the frequency and duration of absence seizures using electroencephalogram EEG recordings. The trial is a Phase 2, single-center, double-blind, placebo-controlled crossover study sponsored by NeuroPro Therapeutics, Inc. Participants will receive either NPT 2042 or a matching placebo twice daily during two treatment periods separated by a 14-day washout. Two different doses of NPT 2042 80mg and 160mg twice daily will be tested. Each participant will receive both the active drug and placebo at different times in a randomized order to compare the effects directly. During the study, participants will undergo EEG monitoring for seizure activity and complete assessments like the Quality of Life in Epilepsy Questionnaire, Digit Symbol Substitution Test, and Epworth Sleepiness Scale. Researchers will track changes in seizure frequency and duration over up to 12 weeks, monitor safety, and evaluate overall quality of life and cognitive function. The total study duration includes treatment and follow-up periods to assess outcomes.

A Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures