A Phase 2 interventional study of Valiloxybate and Placebo in Parkinson Disease and Excessive Daytime Somnolence, sponsored by XWPharma. Withdrawn. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by XWPharma · Phase 2, Interventional, and Treatment
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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.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →XWPharma is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
XW10172 Modified Release (MR) Granules for Oral Suspension
Drug: Valiloxybate
Placebo Granules for Oral Suspension
Other: Placebo
XW10172 MR Granules for Oral Suspension
Also known as: XW10172 MR
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2021.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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XWPharma