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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05056194
• Other study ID #: XW10172-104
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2021
• Source: XWPharma
• Contact: Beth Zib
• Phone: 650-885-9682
• Email: Beth.Zib[@]XWPharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Excessive Daytime Somnolence
• Parkinson Disease
• Sleepiness

Intervention

Drug:
• Valiloxybate
XW10172 MR Granules for Oral Suspension

Other:
• Placebo
Placebo Granules for Oral Suspension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XWPharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Epworth Sleepiness Scale.		6 weeks
Secondary	Difference between XW10172 and placebo in the change from baseline to end-of-maintenance in the Caregiver Global Impression of Change.		6 weeks
Secondary	Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Multiple Sleep Latency Test		6 weeks
Secondary	Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Parkinson's Fatigue Scale 16.		6 weeks
Secondary	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