Safety and Biomarker Study with EPI-589 in Parkinson's Disease
Research type
Research Study
Full title
A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects
IRAS ID
185564
Contact name
Martin Thoolen
Contact email
Sponsor organisation
Edison Pharmaceuticals Inc.
Eudract number
2015-001786-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
US IND, 126795
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
Parkinson’s disease is a progressive neurological condition for which there are no disease modifying/“curative” treatments. We know that in some patients there is a disturbance of energy production in nerve cells (relating to mitochondrial function) which can lead to the production of harmful chemicals (oxidative stress) which can lead to nerve cell damage. Oxidative stress is thought to be an important cause of the symptoms of Parkison's disease. Blood, cerebral spinal fluid (CSF), and urine sample analysis techniques will be used to assess oxidative stress in this study.
This study will evaluate a new drug, EPI-589, which will target these processes. Phase I studies have been carried out to evaluate the pharmacokinetics, safety, and tolerability of oral doses of EPI-589 in healthy subjects, Studies EPI589-13-022 and EPI589-14-01. None of the vital signs, ECG parameters, or clinical laboratory test results showed a clinically relevant change compared to baseline.
This study will evaluate patient safety and the effect of EPI-589 on biochemical processes in the body.
Approximately 40 subjects with Parkinson’s disease, including 20 subjects with genetically-defined subtypes, will be recruited onto the study. Subjects will be given 3 months of study treatment of EPI-589 500mg twice a day, preceded by a 1-month baseline parameter run-in period.
REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/0006
Date of REC Opinion
15 Jan 2016
REC opinion
Favourable Opinion