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Study of ALK-001 on the Progression of Stargardt Disease

Study acronym: NORTHSTAR
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 10 → 14 locations
    • Eligibility criteria expanded, about 10 words
  2. Trial sites expanded: 5 → 10 locations
    • Start date changed from estimate of Jun 2026 to Jun 3, 2026
    v10
  3. Site details revised at 1 of 5 sitesv9
  4. Study sites: 4 to 5v8
  5. Start date: Apr 2026 to Jun 2026
    • Study sites: 3 to 4
    v7
  6. Study sites: 1 to 3v6
  7. Recruitment opened
    • Study sites: 0 to 1
    • Start date: Mar 2026 to Apr 2026
    v5
  8. Re-verified, no change to tracked fieldsv4
  9. Study title shortened, about 2 wordsv3
  10. Study title shortened, about 6 wordsv2
  11. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study evaluates the efficacy and safety of investigational study drug ALK-001 in participants 8 to 45 years of age, inclusive, with symptoms and signs of autosomal recessive Stargardt disease (STGD)
Trial Details
NCT Number NCT07419334
Lead Sponsor Alkeus Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Stargardt Disease
Related terms Stargardt Disease
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov