Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-29 @ 1:47 AM
Study NCT ID:
NCT02462603
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2015-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease
Sponsor:
Edison Pharmaceuticals Inc
Organization:
Study Overview
Official Title:
A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson's Disease Subjects
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: