NCT05056194

Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease Study

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: XWPharma · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease
• Excessive Daytime Somnolence

Interventions

Type	Name	Description
DRUG	Valiloxybate	XW10172 MR Granules for Oral Suspension
OTHER	Placebo	Placebo Granules for Oral Suspension

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2021-09-24
• Last updated: 2025-03-19

Regulatory

• FDA-regulated drug study