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Prospective Natural History Study of POLG Disease

NCT07775872 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-08-20

No results posted yet for this study

Summary

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

Conditions

  • PolG, Primary Mitochondrial Myopathy

Sponsors & Collaborators

  • Jeeva Clinical Trials Inc

    collaborator UNKNOWN

  • ClinTrek Research Private Limited

    collaborator UNKNOWN

  • United Mitochondrial Disease Foundation (UMDF)

    collaborator UNKNOWN

  • The POLG Foundation

    lead OTHER

Principal Investigators

  • Amel Kaara · Harvard Medical School & Massachusetts General Hospital

  • Omar Hikmat · Haukeland University / Bergen University

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-06-17
Completion
2031-06-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07775872 on ClinicalTrials.gov