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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2026 → Dec 2028
See other at-risk trials from Alkeus Pharmaceuticals, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Dec 2028 Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Study completion pushed from Dec 2026 to Dec 2029
    • Eligibility criteria expanded, about 12 words
    • Publications: details revised at 4 of 5 entries
  2. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: 140 to 200
    • Study sites: 1 to 8
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Primary and study completion dates: Dec 2024 to Dec 2026v3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04239625
Lead Sponsor Alkeus Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Stargardt Disease, Stargardt Macular Degeneration, Stargardt Macular Dystrophy, Autosomal Recessive Stargardt Disease 1 (ABCA4-related)
Related terms Stargardt Disease
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov