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Prospective Natural History Study of POLG Disease

Study acronym: PIONEER
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Trial sites expanded: 6 → 21 locations
    • Start date changed from estimate of Aug 1, 2026 to Jun 17, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 11 of 13 entries
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The PIONEER study is a prospective, natural history study dedicated to characterizing the clinical progression of POLG-related disorders. The research aims to bridge the gap between genetic diagnosis and drug development by mapping how these rare mitochondrial conditions evolve over time. By observing the disease's natural trajectory through a multi-center approach, The study identifies critical clinical milestones that serve as a foundation for evaluating therapeutic efficacy and future therapeutic interventions
Trial Details
NCT Number NCT07775872
Lead Sponsor The POLG Foundation
Collaborators: Jeeva Clinical Trials Inc, ClinTrek Research Private Limited, United Mitochondrial Disease Foundation (UMDF)
Conditions
(from sponsor)		 PolG, Primary Mitochondrial Myopathy
Related terms Ataxia, Epilepsy, Mitochondrial Myopathies, Ophthalmoplegia, Chronic Progressive External, Seizures
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov