NCT06525649

A Double Blind, Randomized, Cross-over Study Examining the Suppression of the Photoparoxysmal EEG Response With NPT 2042

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: NeuroPro Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A double-blind, placebo-controlled, crossover trial to investigate the PPR of approximately 5 subjects with a known stable PPR on EEG, using 2 doses of NPT 2042 compared to placebo.

Detailed description

This study will compare the effect of 2 doses of NPT 2042 on the photoparoxysmal- electroencephalogram (EEG) response (PPR), compared to placebo. Subjects will be screened to ensure they have a stable PPR. Subjects will then return for 3 treatment visits, each lasting 1 day, with minimum 14-day washout period between visits. Subjects will be randomized to a treatment sequence in order to receive NPT 2042 (160 mg or 240 mg) or matching placebo on each treatment day. The PPR will be measured at predose (-0.5 hours) and 0.5, 1, 2, 3, 4, and 6 hours postdose. The PPR of the active treatments will be compared to the placebo response.

Conditions

• Photosensitive Epilepsy
• Epilepsy

Interventions

Type	Name	Description
DRUG	NPT 2042	NPT 2042 is a new drug being developed as an anti-seizure treatment.

Timeline

• Start date: 2024-08-21
• Primary completion: 2025-06-26
• Completion: 2025-06-26
• First posted: 2024-07-29
• Last updated: 2025-07-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study