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A Study of GlcNAc on Tear Production in NGLY1-CDDG

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from Eva Morava-Kozicz

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 2026 to Dec 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Site details revised at 2 of 2 sites
    • Collaborators: details revised at 2 of 2 entries
  2. Primary and study completion dates: Jun 2025 to Dec 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v16
  3. Start date changed from estimate of Mar 2025 to Jan 24, 2025v15
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2024 to Mar 2025
    • Site details revised at 2 of 2 sites
    v14
  5. Start date: Oct 2024 to Nov 2024v13
Show 11 earlier versionsHide 11 earlier versions
  1. Site contacts updated at 2 of 2 sitesv12
  2. Start date: Aug 2024 to Oct 2024
    • Eligibility criteria expanded, about 148 words
    • Site contacts updated at 2 of 2 sites
    v11
  3. Start date: May 2024 to Aug 2024v10
  4. Secondary endpoints: 5 to 6v9
  5. Start date: Feb 2024 to May 2024v8 Show 7 more changesShow less
    • Primary endpoint revised
    • Study sites: 1 to 2
    • Primary and study completion dates: Mar 2025 to Jun 2025
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints expanded, about 24 words
    • Study description expanded, about 7 words
    • Collaborators expanded, about 7 words
  6. Start date: Nov 2023 to Feb 2024
    • Primary and study completion dates: Nov 2024 to Mar 2025
    v7
  7. Phase: Phase 1 to Phase 2v6 Show 6 more changesShow less
    • Start date: Sep 2023 to Nov 2023
    • Enrollment target: 16 to 18
    • Study sites: 0 to 1
    • Primary and study completion dates: Jun 2024 to Nov 2024
    • Eligibility criteria expanded, about 10 words
    • Study title shortened, about 3 words
  8. Start date: May 2023 to Sep 2023v5
  9. Re-verified, no change to tracked fieldsv4
  10. Start date: Oct 8, 2022 to May 2023
    • Primary completion date: Jun 30, 2024 to Jun 2024
    • Study completion date: Sep 30, 2024 to Jun 2024
    v3
  11. Phase: Phase 2/3 to Phase 1v2 Show 4 more changesShow less
    • Primary completion date: Nov 30, 2024 to Jun 30, 2024
    • Study completion date: Mar 30, 2025 to Sep 30, 2024
    • Start date: Dec 1, 2022 to Oct 8, 2022
    • Study title expanded, about 2 words
  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.
In patients with NGLY1-CDDG, the disorder can lead to eye damage due to not being able to produce enough tears. This study is being done to see if the dietary supplement, GlcNAc, improves tear production in patients with NGLY1-CDDG.
Trial Details
NCT Number NCT05402345
Lead Sponsor Eva Morava-Kozicz
Collaborators: Children's Hospital of Philadelphia, Seattle Children's Hospital
Conditions
(from sponsor)		 NGLY1 Deficiency
Related terms NGLY1 deficiency
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov