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

XWPharma

Status and phase: Withdrawn; Phase 2

Conditions: Excessive Daytime Somnolence; Parkinson Disease

Treatments: Other: Placebo; Drug: Valiloxybate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05056194

XW10172-104

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Valiloxybate

Experimental group

Description:

XW10172 Modified Release (MR) Granules for Oral Suspension

Treatment:

Drug: Valiloxybate

Placebo

Placebo Comparator group

Description:

Placebo Granules for Oral Suspension

Treatment:

Other: Placebo