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

Timeline

Start

2021-11-01

Primary completion

2022-11-01

Completion

2022-11-01

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision”

Drugs

Indications