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.
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)
Subject is aged 16-75 years at the time of consent/assent
Subject is diagnosed with genetic generalized epilepsy with absence seizures (consistent with the International League Against Epilepsy (ILAE) Classification of Seizures (2017))
Subject has electroencephalogram (EEG) evidence of bilateral synchronous generalized paroxysmal spike-wave (2.5 Hz to 6 Hz) bursts lasting 3 seconds or more at least 4 times on the screening 72-hour ambulatory EEG.
Subject has metabolic or mitochondrial encephalopathies, seizures associated with structural abnormalities, or infection-related seizures.
Subject has a developmental epileptic encephalopathy (e.g. Lennox-Gastaut syndrome)
Subject has a history of convulsive status epilepticus within the past year.
Subject has a history of surgical intervention for treatment of epilepsy
Crossover
NPT 2042
DrugNPT 2042 is a new drug being developed as an anti-seizure treatment
Placebo
Other interventionPlacebo Comparator
Mean and median across subjects of the within subject difference in percent change from treatment period baseline of the frequency of absence seizures
Mean and median across subjects of the within subject difference in percent change from treatment period baseline of the frequency of absence seizures (defined as 2.5-6 Hz spike-wave bursts lasting greater than 3 seconds) between NPT 2042 and placebo.
Mean and median across subjects of the within subject difference between NPT 2042 and placebo on absence seizures
Mean and median across subjects of the within subject difference between NPT 2042 and placebo on absence seizures (defined as 2.5-6 Hz spike-wave bursts lasting greater than 3 seconds) average duration.
Mean and median across subjects of the within subject categorical difference in percent change between NPT 2042 and placebo of the frequency of absence seizure
Mean and median across subjects of the within subject categorical difference in percent change between NPT 2042 and placebo of the frequency of absence seizure (defined as 2.5-6 Hz spike wave bursts lasting greater than 3 seconds) using the following categories: * 1 - \< 3 seconds * 3 - 5 seconds * \>5 - 10 seconds * \>10 seconds
The proportion of NPT 2042- vs. placebo-treated subjects meeting the study specific response criteria
The proportion of NPT 2042- vs. placebo-treated subjects meeting the following response criteria: * ≥50% decrease in endpoint seizure frequency compared to treatment period baseline * ≥75% decrease in endpoint seizure frequency compared to treatment period baseline * Seizure freedom
The mean change from Baseline across subjects of the within subject difference between NPT 2042 and placebo on the Quality of Life in Epilepsy Questionnaire (QOLIE-31-P)
The mean change from Baseline across subjects of the within subject difference between NPT 2042 and placebo on the Quality of Life in Epilepsy Questionnaire (QOLIE-31-P)
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