Clinical Trial

Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE)

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The purpose of this open-label, multicenter study is to determine the long-term safety, pharmacokinetics and effects of ALK-001 (C20-D3-retinyl acetate) on the progression of Stargardt disease. This study is an extension of NCT02402660 and enrolls participants who are at least 8 years old. Enrollment is by invitation only. Funding Source - FDA OOPD
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-01-22; most recent amendment 2025-04-24.
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-04-24
Trial Details
NCT Number NCT04239625
Lead Sponsor Alkeus Pharmaceuticals, Inc.
Conditions Stargardt Disease, Stargardt Macular Degeneration, Stargardt Macular Dystrophy, Autosomal Recessive Stargardt Disease 1 (ABCA4-related)
Enrollment 200 participants
Start Date 2019-12-20
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-27