clinical trial · NCT05056194
Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease Study
XWPharma·phase2·withdrawn
Parkinson DiseaseExcessive Daytime SomnolenceValiloxybatePlacebo
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.
started
Nov 1, 2021
primary completion
Nov 1, 2022
completion
Nov 1, 2022
last updated
Mar 19, 2025
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol