Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT03624920
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2018-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Sponsor:
Theranexus
Organization:
Study Overview
Official Title:
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Status:
COMPLETED
Status Verified Date:
2020-10
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 is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.
Detailed Description:
The treatment duration is 2 weeks per period. Each treatment period is followed by a one-week washout period.
Study Oversight
Has Oversight DMC:
None
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?: