Safety and Efficacy of NPI-001 Tablets for RP Associated With Usher Syndrome (SLO RP)
Safety and Efficacy of NPI-001 Tablets for RP Associated With Usher Syndrome (SLO RP)
Brief 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.
Detailed Description:
This study will examine the safety and efficacy of oral NPI-001 Tablets as compared to oral placebo tablets for 24 months in subjects with vision loss due to RP associated with Usher syndrome.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: NPI-001 Tablets versus Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-masked
Primary Purpose: Treatment
Official Title: Safety and Efficacy of NPI-001 Tablets Versus Placebo for Treatment of Retinitis Pigmentosa Associated With Usher Syndrome
Actual Study Start Date: September 3, 2020
Estimated Primary Completion Date: September 2023
Estimated Study Completion Date: September 2023
Arm:
- Experimental: NPI-001
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 48 |
| Actual Study start date | 03 September 2020 |
| Estimated Study Completion Date | 01 September 2023 |