NPT 2042 for Epilepsy

Overseen By JoAnn Giannone

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: NeuroPro Therapeutics, Inc.

Must be taking: Antiseizure medications

Disqualifiers: Metabolic encephalopathies, Severe autism, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

What is the purpose of 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 80 mg BID orally or matching placebo BID in each of two treatment periods.

Eligibility Criteria

This trial is for people aged 16-75 with Genetic Generalized Epilepsy (GGE) and absence seizures. Participants must meet specific criteria, which are not detailed here.

Inclusion Criteria

I agree to use effective birth control during and for 28 days after the study.

I (or my guardian) have signed the consent form and agree to follow the study rules.

I am between 16 and 75 years old.

Exclusion Criteria

I have a brain disorder related to metabolism or mitochondria, or seizures due to infection or structural brain changes.

I have a severe form of epilepsy like Lennox-Gastaut syndrome.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either NPT 2042 80 mg BID or matching placebo BID

Up to 12 weeks

Washout

A 14-day washout period between treatment periods

2 weeks

Treatment Period 2

Participants receive the alternate treatment (either NPT 2042 80 mg BID or matching placebo BID)

Up to 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NPT 2042
• Placebo

Trial Overview The study tests NPT 2042 against a placebo in reducing the frequency and duration of absence seizures in GGE patients. It's a double-blind, crossover study where participants will take either the drug or placebo twice daily.

Participant Groups

Group I: NPT 2042 80mg Active Control 2 Interventions

NPT 2042 80mg BID

Group II: Placebo Placebo Group 2 Interventions

Matching placebo for active comparator

Who Is Running the Clinical Trial?

NeuroPro Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

70+