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A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint revised
    • Secondary endpoints: 6 to 2
    • Study description expanded, about 2 words
    v7
  2. Minor Study completion date: Jun 30, 2021 to Jun 30, 2022v6
  3. Minor Primary completion date changed from estimate of Jun 30, 2020 to Aug 9, 2020
    • Study completion date: Jul 31, 2020 to Jun 30, 2021
    v5
  4. Minor Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 15 to confirmed 19
    v4
  5. Minor Study sites: 1 to 2v3
  6. Notable Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 4 more changesShow less
    • Primary completion date: Sep 30, 2018 to Jun 30, 2020
    • Start date changed from estimate of Jul 1, 2018 to Nov 5, 2018
    • Study sites: 0 to 1
    • Study completion date: Dec 31, 2019 to Jul 31, 2020
  7. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
2 trials monitored
See 1 trial at risk
The purpose of this study is to evaluate the efficacy and safety of RT001 in patients with Infantile Neuroaxonal Dystrophy (INAD).
Trial Details
NCT Number NCT03570931
Lead Sponsor Biojiva LLC
Conditions
(from sponsor)
Infantile Neuroaxonal Dystrophy
Related terms Neuroaxonal Dystrophies
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov