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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-75
SponsorNeuroPro Therapeutics, Inc.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • NPT 2042
  • Placebo

Treatment groups

12 Participants
are divided into 4 treatment groups

Sponsors and collaborators