Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease Study
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|ClinicalTrials.gov Identifier: NCT05056194|
Recruitment Status : Not yet recruiting
First Posted : September 24, 2021
Last Update Posted : September 24, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Excessive Daytime Somnolence||Drug: Valiloxybate Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
XW10172 Modified Release (MR) Granules for Oral Suspension
XW10172 MR Granules for Oral Suspension
Other Name: XW10172 MR
Placebo Comparator: Placebo
Placebo Granules for Oral Suspension
Placebo Granules for Oral Suspension
- Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Epworth Sleepiness Scale. [ Time Frame: 6 weeks ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
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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|
- 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.
- 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.
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
|Contact: Beth Zib||650-885-9682||Beth.Zib@XWPharma.com|
|Study Director:||Daniel M. Canafax, PharmD||XWPharma|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Disorders of Excessive Somnolence
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders