Clinical Trial

Phase 2 Tolerability and Effects of ALK-001 on Stargardt Disease

Study acronym: TEASE
Enrolling by Invitation Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated April 27, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this study is to determine the long term safety and tolerability of ALK-001 (C20-D3-retinyl acetate), and to explore the effects of ALK-001 on the progression of Stargardt disease in patients between the ages of 8 and 70 years old. Funding Source - FDA OOPD
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2015-03-27; most recent amendment 2025-04-24.
Status change: Recruiting → Enrolling by Invitation 2025-04-24
Status change: Not Yet Recruiting → Recruiting 2015-08-25
Trial Details
NCT Number NCT02402660
Lead Sponsor Alkeus Pharmaceuticals, Inc.
Conditions Stargardt Disease, Stargardt Macular Degeneration, Stargardt Macular Dystrophy, Autosomal Recessive Stargardt Disease 1 (ABCA4-related)
Enrollment 160 participants
Start Date 2015-08
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-27