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Safety and Efficacy of NPI-001 Tablets for RP Associated With Usher Syndrome

NCT04355689 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-12-23

No results posted yet for this study

Summary

This study will examine the safety and efficacy of NPI-001 Tablets as compared to placebo for 24 months in subjects with vision loss due to RP associated with Usher syndrome.

Conditions

  • Usher Syndromes

Interventions

DRUG

NPI-001

oral tablet

OTHER

Placebo

Placebo tablets

Sponsors & Collaborators

  • Foundation Fighting Blindness

    collaborator OTHER

  • Nacuity Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Lee Anderson, MD · Nacuity Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2025-06-20
Completion
2026-04-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04355689 on ClinicalTrials.gov