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Validation of Oxygen Nanosensor in Mitochondrial Myopathy

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv15
  2. Notable Primary and study completion dates: Aug 1, 2025 to Aug 1, 2027v14
  3. Notable Primary and study completion dates: Nov 1, 2024 to Aug 1, 2025v13
  4. Notable Phase: Not applicable to Phase 1
    • Collaborator revised
    v12
  5. Minor Start date changed from estimate of Jan 2023 to Jan 17, 2023v11
Show 9 earlier versionsHide 9 earlier versions
  1. Notable Start date: Nov 1, 2022 to Jan 2023v10
  2. Notable Start date: Sep 2022 to Nov 1, 2022
    • Primary and study completion dates: Sep 2024 to Nov 1, 2024
    v9
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Collaborators: 3 to 1
    v8
  4. Notable Primary and study completion dates: Sep 2022 to Sep 2024v7
  5. Notable Start date: Sep 2021 to Sep 2022v6
  6. Notable Start date: Mar 2021 to Sep 2021
    • Primary and study completion dates: Mar 2022 to Sep 2022
    v5
  7. Notable Start date: Sep 2020 to Mar 2021
    • Primary and study completion dates: Nov 2021 to Mar 2022
    v4
  8. Notable Start date: Mar 2020 to Sep 2020v3
  9. Notable Start date: Nov 2019 to Mar 2020v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Past mitochondrial disease treatment studies have been unsuccessful in determining treatment efficacy, and a major factor has been the lack of validated biomarkers in mitochondrial myopathy (MM). There is currently a growing number of potential new treatments to be tested through MM clinical intervention trials, which has created a pressing need for quantitative biomarkers that reliably reflect MM disease severity, progression, and therapeutic response. The purpose of the study is to measure the efficacy of an electrochemical oxygen nanosensor to measure in vivo mitochondrial function in human muscle tissue, and its ability to discriminate MM patients from healthy volunteers. The data and results from this nanosensor study may contribute to current and future research, including improved diagnostic and therapeutic approaches for patients with mitochondrial disease.
Trial Details
NCT Number NCT04086329
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)
Mitochondrial Myopathies, Mitochondrial Diseases
Related terms Mitochondrial Diseases, Mitochondrial Myopathies
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov