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NCT04239625 · ClinicalTrials.gov registry record · Phase 2
Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE)
A Phase 2 study of Stargardt Disease and Stargardt Macular Dystrophy, sponsored by Alkeus Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 8
- Study locations
NCT04239625 is a Phase 2 study of Stargardt Disease and Stargardt Macular Dystrophy that is active but no longer recruiting, run by Alkeus Pharmaceuticals. The registered enrollment target is 200 participants, above the 79-participant average among 16 other Stargardt Disease trials with a reported enrollment target (153% higher). The trial reports 8 study locations across 8 states.
The verdict
NCT04239625, a Phase 2 study of Stargardt Disease and Stargardt Macular Dystrophy, is active but no longer recruiting, sponsored by Alkeus Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 8
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG ALK-001
Study Locations (8)
Arizona
- Alkeus Site - Phoenix
California
- Alkeus Site - Los Angeles
Colorado
- Alkeus Site - Aurora
Florida
- Alkeus Site - Gainesville
Indiana
- Alkeus Site - Indianapolis
Michigan
- Alkeus Site - Grand Rapids
New York
- Alkeus Site - Westbury
Washington
- Alkeus Site - Silverdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04239625
The ClinicalTrials.gov registry entry for NCT04239625 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 79-participant average among 16 other Stargardt Disease trials with a reported enrollment target (153% higher). The listed sponsor is Alkeus Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Stargardt Disease appearing as the primary indexed condition, and to 1 intervention - of which ALK-001 is the first listed.
NCT04239625 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Arizona, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04239625 about?
NCT04239625 is a clinical study titled "Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE)". 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. Enrollmen...
What is the current status of trial NCT04239625?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2019-12-20. Estimated completion is 2026-12.
What conditions does trial NCT04239625 study?
This clinical trial studies the following conditions: Stargardt Disease, Stargardt Macular Dystrophy, Stargardt Macular Degeneration, Autosomal Recessive Stargardt Disease 1 (ABCA4-related).
What interventions are being tested in trial NCT04239625?
The interventions under investigation include: ALK-001 (DRUG).
Who is sponsoring clinical trial NCT04239625?
This trial is sponsored by Alkeus Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04239625 being conducted?
This trial has 8 study locations across Arizona, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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