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