A Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized … (NCT06769659) | Clinical Trial Compass
RecruitingPhase 2
A Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures
United States10 participantsStarted 2025-03-11
Plain-language 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 80 mg BID orally or matching placebo BID in each of two treatment periods.
Who can participate
Age range16 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 been on a stable dose of at least one antiseizure medication (ASM) for at least 30 days. Vagal nerve stimulation at stable settings (for at least 30 days before screening), without use of the magnet, is also acceptable.
✓. Subject has normal cognition and no clinically significant abnormalities on neurological examination at screening in the opinion of the Investigator
✓. Subject is in otherwise good health (with the exception of epilepsy), as determined by the investigator, and as documented in the medical history, physical examination, and screening laboratory investigations
✓. Subject has a body mass index (BMI) between 18 and 40 kg/m2 inclusive, at screening
Exclusion criteria
✕. Subject has metabolic or mitochondrial encephalopathies, seizures associated with structural abnormalities, or infection-related seizures.
What they're measuring
1
Mean and median across subjects of the within subject difference in percent change from treatment period baseline of the frequency of absence 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
✕. Subject has a history of nonepileptic seizures (e.g., metabolic, structural, or paroxysmal non epileptic seizures)
✕. Subject has severe intellectual disability, severe autism spectrum disorder, or severe developmental disorder such that the subject cannot consent or assent to participate or cannot cooperate with the study procedures
✕. Female subject who is pregnant or lactating
✕. Subject has any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the subject from the study