Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE)
Running, not enrolling · Phase 2
Conditions studied: Stargardt Disease, Stargardt Macular Degeneration, Stargardt Macular Dystrophy, Autosomal Recessive Stargardt Disease 1 (ABCA4-related)
In brief
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
Key facts
- Study ID
- NCT04239625
- Run by
- Alkeus Pharmaceuticals, Inc.
- People needed
- 200
- Starts
- 2019-12-20
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-04-27
Who can join
Age: 8 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Alkeus Site — Phoenix, Arizona, United States
- Alkeus Site — Los Angeles, California, United States
- Alkeus Site — Aurora, Colorado, United States
- Alkeus Site — Gainesville, Florida, United States
- Alkeus Site — Indianapolis, Indiana, United States
- Alkeus Site — Grand Rapids, Michigan, United States
- Alkeus Site — Westbury, New York, United States
- Alkeus Site — Silverdale, Washington, United States
Full record on ClinicalTrials.gov
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