drugset / Trial / NCT07290530

24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome

NCT07290530

Phase 3 Not yet recruiting 80 enrolled Nacuity Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial is to learn if NPI-001 works to prevent progression of retinitis pigmentosa in adults diagnosed with Usher syndrome. It will also provide information about the safety of NPI-001. The main questions it aims to answer are: Does NPI-001 slow down the loss of photoreceptors? What medical problems do participants have when taking NPI-001? Researchers will compare NPI-001 to a placebo (a look-alike substance that contains no drug) to see if NPI-001 works to preserve vision. Participants will: Take NPI-001 or a placebo twice a day, every day for 24 months Visit the clinic 9 times for checkups and tests

Timeline

Start
2026-12
Primary completion
2029-07
Completion
2029-07

Drugs

EvaluationDrugModalityDoseRoute
Subject N-Acetylcysteine Amide Unknown 250 mg