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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05056194
Recruitment Status : Not yet recruiting
First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
XWPharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Excessive Daytime Somnolence Drug: Valiloxybate Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Valiloxybate
XW10172 Modified Release (MR) Granules for Oral Suspension
 Drug: Valiloxybate
XW10172 MR Granules for Oral Suspension
Other Name: XW10172 MR
Placebo Comparator: Placebo
Placebo Granules for Oral Suspension
 Other: Placebo
Placebo Granules for Oral Suspension


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05056194


Contacts
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Contact: Beth Zib 650-885-9682 Beth.Zib@XWPharma.com

Sponsors and Collaborators
XWPharma
Investigators
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Study Director: Daniel M. Canafax, PharmD XWPharma
More Information
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Responsible Party: XWPharma
ClinicalTrials.gov Identifier: NCT05056194    
Other Study ID Numbers: XW10172-104
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Disorders of Excessive Somnolence
Sleepiness
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