Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 5:16 PM
Study NCT ID:
NCT05056194
Status:
WITHDRAWN
Last Update Posted:
2025-03-19
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease Study
Sponsor:
XWPharma
Organization:
Study Overview
Official Title:
A Double-blind, Randomized, Placebo-controlled, Parallel, Study to Assess the Efficacy and Safety of XW10172 MR for the Treatment of Excessive Daytime Sleepiness in Patients with Parkinson's Disease
Status:
WITHDRAWN
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Following screening visit and verification of inclusion/exclusion criteria and informed consent, participants will undergo a multiple sleep latency test (MSLT) and polysomnogram (PSG) assessments to confirm eligibility for randomization. Participants will be randomized to two groups: placebo or XW10172 MR. The drug will be taken orally at bedtime for 6 weeks of treatment that will consist of a 2-week dose escalation/titration period and a 4-week stable-dose maintenance period. There will be a 2-week safety period following dosing.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: