Trials / Active Not Recruiting
Active Not RecruitingNCT04239625
Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE)
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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Alkeus Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 8 Years – 70 Years
- Healthy volunteers
- Not accepted
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
- Stargardt Disease
- Stargardt Macular Degeneration
- Stargardt Macular Dystrophy
- Autosomal Recessive Stargardt Disease 1 (ABCA4-related)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALK-001 | Oral administration of a pill for up to 24 months |
Timeline
- Start date
- 2019-12-20
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2020-01-27
- Last updated
- 2025-04-27
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04239625. Inclusion in this directory is not an endorsement.