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A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jun 12, 2023 to Jun 12, 2030
    • Study completion date: Dec 2028 to Dec 2030
    • Publications: details revised at 3 of 6 entries
    v13
  2. Trial status: Active, Not Recruiting to Recruiting
    • Study completion date: Dec 2026 to Dec 2028
    • Site details revised at 14 of 14 sites
    v12
  3. Study completion date: Nov 2024 to Dec 2026
    • Publications: details revised at 3 of 6 entries
    v11
  4. Primary completion date changed from estimate of Jun 2023 to Jun 12, 2023v10
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 14 of 14 sites
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Aug 2023 to Jun 2023v8
  2. Study sites: 15 to 14v7
  3. Study sites: 16 to 15v6
  4. Site details revised at 3 of 16 sitesv5
  5. Site details revised at 1 of 16 sitesv4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 2023 to Aug 2023
    • Study completion date: Sep 2024 to Nov 2024
    • Start date changed from estimate of Jun 2022 to Jun 30, 2022
    v3
  7. Start date: Feb 2022 to Jun 2022
    • Primary completion date: Dec 2022 to Mar 2023
    • Study completion date: Apr 2024 to Sep 2024
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A pivotal, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 4 and older with a confirmed diagnosis of Niemann Pick disease type C (NPC). The objective of this study is to evaluate the safety, tolerability and efficacy of N-acetyl-L-leucine (IB1001) compared to standard of care. Following this randomized, double-blind, placebo-controlled "Parent Study", an extension phase is conducted for (1) patients who completed the "Parent Study" and (2) patients who are enrolled directly into the Extension Phase. Currently, the Extension Phase provides patients with 3 years of open-label treatment.
Trial Details
NCT Number NCT05163288
Lead Sponsor IntraBio Inc
Conditions
(from sponsor)		 Niemann-Pick Disease, Type C
Related terms Niemann-Pick Disease, Type C
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov