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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease; Excessive Daytime Somnolence
• Intervention / Treatment: Drug: Valiloxybate; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Beth Zib; Phone Number: 650-885-9682; Email: Beth.Zib@XWPharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Valiloxybate; XW10172 Modified Release (MR) Granules for Oral Suspension	Drug: Valiloxybate; XW10172 MR Granules for Oral Suspension; Other Names: XW10172 MR
Placebo Comparator: Placebo; Placebo Granules for Oral Suspension	Other: Placebo; Placebo Granules for Oral Suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: XWPharma
• Investigators: Study Director: Daniel M. Canafax, PharmD, XWPharma

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: XW10172-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No