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Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE)
Sponsor: Alkeus Pharmaceuticals, Inc.
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
Official title: A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long Term Safety, Tolerability, Pharmacokinetics and Effects of ALK-001 on the Progression of Stargardt Disease
Key Details
Gender
All
Age Range
8 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2019-12-20
Completion Date
2026-12
Last Updated
2025-04-27
Healthy Volunteers
No
Conditions
Interventions
ALK-001
Oral administration of a pill for up to 24 months
Locations (8)
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