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

NCT05056194 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: XW10172-104
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease; Excessive Daytime Somnolence

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Valiloxybate

EXPERIMENTAL

XW10172 Modified Release (MR) Granules for Oral Suspension

Drug: Valiloxybate

Placebo

PLACEBO COMPARATOR

Placebo Granules for Oral Suspension

Other: Placebo

Interventions

Valiloxybate DRUG

XW10172 MR Granules for Oral Suspension

Also known as: XW10172 MR

Valiloxybate

Placebo OTHER

Placebo Granules for Oral Suspension

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• XWPharma: lead

MeSH Terms

Conditions

Parkinson Disease; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Daniel M. Canafax, PharmD

  XWPharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 24, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share