A Single-center, Double-blind, Placebo-controlled Crossover Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures

NeuroPro Therapeutics, Inc.

Summary

This study will compare the effect of NPT 2042 and placebo in subjects with GGE on the frequency and duration of electroencephalographic absence seizures, separated by a 14-day washout period. The study will be a single-center, double-blind, crossover study with subjects receiving either NPT 2042 BID orally or matching placebo BID in each of two treatment periods. Two doses of NPT 2042 will be evaluated.

Eligibility

Age range: 16–75 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Subject is capable of and provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) 2. Subject is aged 16-75 years at the time of consent/assent 3. Subject is diagnosed with genetic generalized epilepsy with absence seizures (consistent with the International League Against Epilepsy (ILAE) Classification of Seizures (2017)) 4. Subject has electroencephalogram (EEG) evide…

Interventions

Drug
NPT 2042
NPT 2042 is a new drug being developed as an anti-seizure treatment
Other
Placebo
Placebo Comparator

Location

Clinical Trials, Inc. (CTI)
Little Rock, Arkansas
dhholderfield@clinicaltrialsinc.com 501-227-6179

A Single-center, Double-blind, Placebo-controlled Crossover Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures

Summary

Eligibility

Interventions

Location

Compensation

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Details

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