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Study of N-acetylcysteine in the Treatment of Patients With the m.3243A>G Mutation and Low Brain Glutathione Levels

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 23, 2026 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Apr 2025 to Mar 2026v7
  2. Primary and study completion dates: Jun 2024 to Apr 2025
    • Start date changed from estimate of Apr 2023 to Jul 6, 2023
    v6
  3. Lead sponsor: Darryl C. De Vivo, MD to Michio Hirano, MD
    • Start date: Dec 1, 2022 to Apr 2023
    • Site contact updated
    v5
  4. Start date: Sep 2022 to Dec 1, 2022v4
  5. Start date: Jun 2022 to Sep 2022v3
  6. Start date: Mar 1, 2022 to Jun 2022v2 Show 4 more changesShow less
    • Primary and study completion dates: Jun 1, 2024 to Jun 2024
    • Eligibility criteria revised
    • Secondary endpoints revised (5)
    • Collaborators expanded, about 5 words
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
N-Acetylcysteine (NAC), an anti-oxidant, will be studied to investigate the effects on brain glutathione levels, cognitive skills, motor skills, and quality of life. A group of 18 participants will take either 1800, 3600 or 5400 mg per day of N-acetylcysteine (NAC) for 3 months in this dose escalation study. The investigators want to determine first if the 3600 mg dose per day is safe and might provide some efficacy. If the 3600 mg dose is safe, then additional participants will be treated with 5400 mg per day of NAC, for up to a total of 18 participants. If the 3600 mg per day dose is unsafe, then participants will be treated with the 1800 mg per day dose. Data from this pilot study will be used to determine the most safe and effective dose of NAC for a future clinical trial.
Trial Details
NCT Number NCT05241262
Lead Sponsor Michio Hirano, MD
Collaborators: United States Department of Defense
Conditions
(from sponsor)		 Mitochondrial Disease
Related terms Deafness, Diabetes Mellitus, MELAS Syndrome, Mitochondrial Diseases
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov