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ACTIVE NOT RECRUITING
NCT04239625
PHASE2

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

Sponsor: Alkeus Pharmaceuticals, Inc.

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

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

Interventions

DRUG

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