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

XWPharma0 sites70 target enrollmentNovember 1, 2021

ConditionsParkinson Disease Excessive Daytime Somnolence

InterventionsValiloxybate Placebo

Overview

Phase: Phase 2
Intervention: Valiloxybate
Conditions: Parkinson Disease
Sponsor: XWPharma
Enrollment: 70
Primary Endpoint: Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Epworth Sleepiness Scale.
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 1, 2021

End Date

November 1, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

XWPharma

Responsible Party

Sponsor

Eligibility Criteria

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 \<
•Hospital Anxiety and Depression Scales (HADS) \>
•Have an occupation that requires variable shift work or routine night shifts or travel across two or more-time zones.

Arms & Interventions

Valiloxybate

XW10172 Modified Release (MR) Granules for Oral Suspension

Intervention: Valiloxybate

Placebo

Placebo Granules for Oral Suspension

Intervention: Placebo

Outcomes

Primary Outcomes

Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Epworth Sleepiness Scale.

Time Frame: 6 weeks

Secondary Outcomes

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)