A Phase IIa Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson's Disease Subjects

Condition


Study Name

A Phase IIa Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson's Disease Subjects (IRB no. 45329)


Phase

Phase II


Summary

The purpose of this study is to evaluate an investigational drug called EPI-589 in patients with mitochondrial subtype and sporadic idiopathic Parkinson’s disease. Mitochondrial subtype (also known as genetically defined subtypes) is a type of Parkinson’s disease with known genetic causes. Idiopathic is a type of Parkinson’s disease with unknown causes.

Researchers aim to determine the effects of EPI-589 on these PD patients. Specifically, the study will examine the effects of EPI-589 treatment on blood chemistry, cerebrospinal fluid, and clinical and biological markers of Parkinson’s. Researchers hope that the treatment will improve energy production in brain nerve cells.


Eligibility

Key Inclusion Criteria

  • Hoehn and Yahr scale stage ≤3.0
  • Ambulatory with or without assistance
  • Agrees to use medically accepted methods of contraception

Key Exclusion Criteria

  • Allergy to EPI-589 or other components of the EPI-589 tablet formulation
  • Use of antioxidant supplements
  • Other Parkinsonian disorders

Please see detailed list of inclusion and exclusion criteria.


Principal Investigator

Michele Tagliati, MD


Contact

Tina Wu
Phone: 424-315-2870
Email: tina.wux@cshs.org