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

Conditions

• Epilepsy, Absence
• Epilepsy, Generalized

Eligibility Criteria

Sex

ALL

Age

16 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• NPT 2042 — DRUG
  NPT 2042 is a new drug being developed as an anti-seizure treatment
• Placebo — OTHER
  Placebo Comparator

Study Details

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.

Key Dates

Start date

Mar 11, 2025

Status verified

May 2026

Primary completion

Aug 30, 2026

Completion

Oct 30, 2026

Study Design

Enrollment

12 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Active Comparator: NPT 2042 80mg
  NPT 2042 80mg BID
• Placebo Comparator: Placebo for NPT 2042 80mg
  Matching placebo for active comparator
• Active Comparator: NPT 2042 160mg
  NPT 2042 160mg BID
• Placebo Comparator: Placebo for NPT 2042 160mg
  Matching placebo for active comparator

Primary Outcome Measure

Mean and median across subjects of the within subject difference in percent change from treatment period baseline of the frequency of absence seizures [ Time Frame: Up to 12 weeks ]

Central Contacts

• JoAnn Giannone
  9196371566
  [email protected]
• Charles Moser
  [email protected]

Locations (1)

Find similar trials in Little Rock, AR

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