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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson Disease, Excessive Daytime Somnolence

Intervention / Treatment
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* Drug: Valiloxybate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Parkinson's disease consistent with the UK-PD Society Brain Bank Criteria and PD duration at least 1 year with modified Hoehn and Yahr stage 1-3 in the OFF state. Patient reported history of excessive daytime sleepiness (e.g., frequent dozing, nodding, or naps). Anti-Parkinson's medications at stable doses for at least 1 month prior to the Baseline Visit and can maintain a fixed, stable dose throughout the study Epworth Sleepiness Scale score of >10 at screening. Female participants of childbearing potential must test negative in a serum pregnancy test at Screening and have a negative urine pregnancy test at the Baseline and Visit. Women with childbearing potential must use an acceptable method of contraception during the study and for at least 30 days after completion of dosing. Exclusion Criteria: Atypical or secondary parkinsonism Significant medical conditions. Evidence of moderate or severe sleep disordered breathing. Drugs that affect sleep including CNS depressants and stimulants. Montreal Cognitive Assessment (MoCA) examine score <24. Hospital Anxiety and Depression Scales (HADS) >11. Have an occupation that requires variable shift work or routine night shifts or travel across two or more-time zones.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valiloxybate<br>XW10172 Modified Release (MR) Granules for Oral Suspension | Drug: Valiloxybate<br>* XW10172 MR Granules for Oral Suspension<br>* Other names: XW10172 MR;|
| Placebo Comparator: Placebo<br>Placebo Granules for Oral Suspension | Other: Placebo<br>* Placebo Granules for Oral Suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Epworth Sleepiness Scale. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between XW10172 and placebo in the change from baseline to end-of-maintenance in the Caregiver Global Impression of Change. |  | 6 weeks | 
| Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Multiple Sleep Latency Test |  | 6 weeks | 
| Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Parkinson's Fatigue Scale 16. |  | 6 weeks | 
| Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Brief Assessment of Cognition composite score |  | 6 weeks |