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World Data on Ambroxol for Patients With GD and GBA Related PD

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2023 to Oct 31, 2030 Completion date: Jan 31, 2024 to Nov 30, 2030v5 Show 1 more changeShow less
    • Completion date: Jan 31, 2024 to Nov 30, 2030
  2. Primary completion date: Jan 1, 2023 to Dec 31, 2023 Completion date: Jan 1, 2023 to Jan 31, 2024 · Study sites revised (3)v4 Show 2 more changesShow less
    • Completion date: Jan 1, 2023 to Jan 31, 2024
    • Study sites revised (3)

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jun 1, 2022 to Jan 1, 2023 Completion date: Jun 1, 2023 to Jan 1, 2023v3 Show 1 more changeShow less
    • Completion date: Jun 1, 2023 to Jan 1, 2023
  4. Trial status: Not Yet Recruiting to Recruiting Primary endpoints: 1 to 2 · Study sites: 0 to 3 · Start date changed from estimate of Jun 1, 2020 to May 6, 2020v2 Show 3 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 0 to 3
    • Start date changed from estimate of Jun 1, 2020 to May 6, 2020

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Ambroxol hydrochloride is an oral mucolytic drug available over-the-counter for many years as cough medicine. In 2009 it was found to also act as a pharmacological chaperone (PC) for mutant glucocerebrosidase, albeit in a several-fold higher dose. Unfortunately, due to its low cost, there have been no pharma-driven clinical trials to establish the use of ambroxol. Thus, data are needed on the safety and efficacy of ambroxol for patients with Gaucher disease (GD).
Trial Details
NCT Number NCT04388969
Lead Sponsor Shaare Zedek Medical Center
Conditions Gaucher Disease, Parkinson Disease, GBA Gene Mutation
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov