Clinical trial NCT05056194: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Parkinson Disease
Excessive Daytime Somnolence
Lead sponsor: XWPharma
Sponsor class: INDUSTRY
First posted: 2021-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Epworth Sleepiness Scale.
timeFrame: 6 weeks
Secondary outcomes:
measure: Difference between XW10172 and placebo in the change from baseline to end-of-maintenance in the Caregiver Global Impression of Change.
timeFrame: 6 weeks
measure: Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Multiple Sleep Latency Test
timeFrame: 6 weeks
measure: Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Parkinson's Fatigue Scale 16.
timeFrame: 6 weeks
measure: Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Brief Assessment of Cognition composite score
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: XWPharma
name: Daniel M. Canafax, PharmD
role: STUDY_DIRECTOR
References: