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

Primary Purpose

Parkinson Disease, Excessive Daytime Somnolence

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Valiloxybate

Placebo

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Valiloxybate

Placebo

Arm Description

XW10172 Modified Release (MR) Granules for Oral Suspension

Placebo Granules for Oral Suspension

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference between XW10172 and placebo in the change from baseline to end-of-maintenance in the Caregiver Global Impression of Change.

Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Multiple Sleep Latency Test

Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Parkinson's Fatigue Scale 16.

Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Brief Assessment of Cognition composite score

Full Information

NCT ID

NCT05056194

First Posted

September 17, 2021

Last Updated

September 17, 2021

Sponsor

XWPharma

1. Study Identification

Unique Protocol Identification Number

NCT05056194

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2021 (Anticipated)

Primary Completion Date

November 1, 2022 (Anticipated)

Study Completion Date

November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

XWPharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Excessive Daytime Somnolence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Valiloxybate

Arm Type

Experimental

Arm Description

XW10172 Modified Release (MR) Granules for Oral Suspension

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Granules for Oral Suspension

Intervention Type

Drug

Intervention Name(s)

Valiloxybate

Other Intervention Name(s)

XW10172 MR

Intervention Description

XW10172 MR Granules for Oral Suspension

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo Granules for Oral Suspension

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Difference between XW10172 and placebo in the change from baseline to end-of-maintenance in the Caregiver Global Impression of Change.

Time Frame

6 weeks

Title

Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Multiple Sleep Latency Test

Time Frame

6 weeks

Title

Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Parkinson's Fatigue Scale 16.

Time Frame

6 weeks

Title

Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Brief Assessment of Cognition composite score

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 <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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beth Zib

Phone

650-885-9682

Beth.Zib@XWPharma.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel M. Canafax, PharmD

Organizational Affiliation

XWPharma

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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