MedTrace Logo

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

NCT05056194 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-03-19

No results posted yet for this study

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

DRUG

Valiloxybate

XW10172 MR Granules for Oral Suspension

OTHER

Placebo

Placebo Granules for Oral Suspension

Sponsors & Collaborators

  • XWPharma

    lead INDUSTRY

Principal Investigators

  • Daniel M. Canafax, PharmD · XWPharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-11-01
Completion
2022-11-01
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05056194 on ClinicalTrials.gov