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Clinical Trials associated with ValiloxybateA 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
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.
An Open-label, Crossover Study to Assess the Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Immediate- and Modified-release Formulations in Healthy Adult Volunteers
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of various formulations of XW10172 in healthy volunteers.
A phase 1, randomized, open-label, single-center, pilot study to evaluate the food effect and pharmacokinetics of single oral doses of XW10172 and sodium oxybate in healthy adult subjects
Start Date05 Feb 2019 |
Sponsor / Collaborator- |
100 Clinical Results associated with Valiloxybate
100 Translational Medicine associated with Valiloxybate
100 Patents (Medical) associated with Valiloxybate
100 Deals associated with Valiloxybate