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A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of GM1 Gangliosidosis or GM2 Gangliosidosis

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Nov 4, 2027 → Feb 6, 2028
See other at-risk trials from Azafaros B.V.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 26 to 27
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 5 of 20 entries
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites reduced: 36 → 26 locations
    v25
  3. Primary completion pushed from Nov 4, 2027 to Feb 6, 2028
    • Study completion pushed from Nov 4, 2027 to Mar 6, 2028
    • Site details revised at 1 of 36 sites
    v24
  4. Primary completion date: Nov 4, 2027 to Feb 6, 2028
    • Study completion date: Nov 4, 2027 to Mar 6, 2028
    v23
  5. Site details revised at 1 of 36 sitesv22
  6. Site details revised at 1 of 36 sitesv21
  7. Sponsor changed: Azafaros A.G. to Azafaros B.V.
    • Site details revised at 1 of 36 sites
    v20
  8. Site details revised at 1 of 36 sitesv19
  9. Site details revised at 1 of 36 sitesv18
  10. Site details revised at 2 of 36 sitesv17
  11. Site details revised at 1 of 36 sitesv16
  12. Site details revised at 6 of 36 sitesv15
  13. Site details revised at 3 of 36 sitesv14
  14. Study sites: 33 to 36v13
  15. Site contacts updated at 1 of 33 sitesv12
  16. Site details revised at 1 of 33 sitesv11
  17. Site details revised at 1 of 33 sitesv10
  18. Site details revised at 6 of 33 sitesv9
  19. Site contacts updated at 8 of 33 sitesv8
  20. Site details revised at 2 of 33 sitesv7
  21. Study sites: 34 to 33v6
  22. Study sites: 31 to 34v5
  23. Site details revised at 3 of 31 sitesv4
  24. Site details revised at 1 of 31 sitesv3
  25. Site details revised at 7 of 31 sitesv2
  26. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Azafaros B.V.
6 trials monitored
See 3 trials at risk
An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of GM1 gangliosidosis or GM2 gangliosidosis
Trial Details
NCT Number NCT07082543
Lead Sponsor Azafaros B.V.
Conditions
(from sponsor)		 Gangliosidoses, GM2, Gangliosidosis, GM1
Related terms Gangliosidoses, GM2, Gangliosidosis, GM1
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov