Trials / Completed
CompletedNCT02462603
Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease
A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson's Disease Subjects
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Edison Pharmaceuticals Inc · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Open-label study with 30-day run-in phase and adaptive design component to include more participants if deemed appropriate by investigators.
Detailed description
This is a within-subject, controlled open-label study seeking to determine if PTC-589 can alter the biochemical signature of Parkinson's disease as assessed by peripheral blood biomarkers, central nervous system (CNS) biomarkers, and urine biomarker analysis. In addition, data on a number of disease-relevant clinical measures will be collected.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PTC-589 | PTC-589 is a redox active molecule and will be provided in a 250 mg tablet formulation. |
Timeline
- Start date
- 2016-05-17
- Primary completion
- 2019-01-08
- Completion
- 2019-01-08
- First posted
- 2015-06-04
- Last updated
- 2022-05-03
- Results posted
- 2022-05-03
Locations
5 sites across 3 countries: United States, Germany, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02462603. Inclusion in this directory is not an endorsement.