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Phase 2 Tolerability and Effects of ALK-001 on Stargardt Disease

Study acronym: TEASE
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Jun 30, 2026 → Jun 30, 2028
See other at-risk trials from Alkeus Pharmaceuticals, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 30, 2026 to Jun 30, 2028 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Study completion pushed from Nov 30, 2026 to Nov 30, 2028
    • Eligibility criteria expanded, about 17 words
    • Publications: details revised at 7 of 8 entries
  2. Primary completion date: Dec 2024 to Jun 30, 2026v18 Show 5 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Enrollment target: 140 to 160
    • Study sites: 8 to 14
    • Study completion date: Mar 2025 to Nov 30, 2026
    • Primary endpoint revised
  3. Re-verified, no change to tracked fieldsv17
  4. Study sites: 7 to 8v16
  5. Primary completion date: Dec 2021 to Dec 2024
    • Study completion date: Mar 2022 to Mar 2025
    • Publications: 6 to 8
    v15
Show 13 earlier versionsHide 13 earlier versions
  1. Re-verified, no change to tracked fieldsv14
  2. Enrollment target: 50 to 140
    • Eligibility criteria expanded, about 20 words
    • Study description shortened, about 176 words
    • Site details revised at 4 of 7 sites
    v13
  3. Primary completion date: Jul 2019 to Dec 2021
    • Study completion date: Dec 2019 to Mar 2022
    v12
  4. Primary completion date: Dec 2017 to Jul 2019
    • Study completion date: Mar 2018 to Dec 2019
    v11
  5. Site contacts updated at 2 of 7 sitesv10
  6. Site details revised at 1 of 7 sitesv9
  7. Site details revised at 1 of 7 sitesv8
  8. Site details revised at 1 of 7 sitesv7
  9. Site details revised at 1 of 7 sites
    • Publications: 5 to 6
    • Eligibility criteria shortened, about 1 word
    v6
  10. Study sites revised (7)v5
  11. Study sites: 4 to 7v4
  12. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 2015 to Aug 2015
    • Study sites: 0 to 4
    • Eligibility criteria shortened, about 158 words
    v3
  13. Start date: Mar 2015 to Jun 2015
    • Publications: 4 to 5
    • Study title expanded, about 2 words
    v2
  1. 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 study is to determine the long term safety and tolerability of ALK-001 (C20-D3-retinyl acetate), and to explore the effects of ALK-001 on the progression of Stargardt disease in patients between the ages of 8 and 70 years old. Funding Source - FDA OOPD
Trial Details
NCT Number NCT02402660
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 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov