Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-28 @ 1:20 PM
Study NCT ID:
NCT03000569
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease
Sponsor:
Biogen
Organization:
Study Overview
Official Title:
A Phase 2, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in Subjects With Parkinson's Disease
Status:
COMPLETED
Status Verified Date:
2023-11
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:
This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29 participants with moderate to severe Parkinson's Disease.
Detailed Description:
Part A of the study is an open-label design with dosing of Levodopa for 3 days followed by SAGE-217 for 4 days.
Part B of the study is an open-label design with evening dosing of SAGE-217 for 7 days as an adjunct to antiparkinsonian agent(s).
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Part B of the study is an open-label design with evening dosing of SAGE-217 for 7 days as an adjunct to antiparkinsonian agent(s).
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: