Parkinson DiseasePhase 2NCT05056194
Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease Study
A Phase 2 study testing Valiloxybate in people with Parkinson Disease and Excessive Daytime Somnolence, run by XWPharma.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease, Excessive Daytime Somnolence
- What is being tested?
- Valiloxybate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this 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
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.
- Conditions
- Parkinson Disease, Excessive Daytime Somnolence
- Being tested
- Valiloxybate, Placebo
- Medical subject headings
- Parkinson Disease, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValiloxybateDrug
Also called XW10172 MR
XW10172 MR Granules for Oral Suspension
PlaceboOther
Placebo Granules for Oral Suspension
| Study group | Role | What they receive |
|---|---|---|
| Valiloxybate | Experimental | XW10172 Modified Release (MR) Granules for Oral Suspension Receives: Drug: Valiloxybate |
| Placebo | Placebo comparator | Placebo Granules for Oral Suspension Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Epworth Sleepiness Scale.
Measured: 6 weeks
Secondary outcomes (4)
Difference between XW10172 and placebo in the change from baseline to end-of-maintenance in the Caregiver Global Impression of Change.
Measured: 6 weeks
Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Multiple Sleep Latency Test
Measured: 6 weeks
Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Parkinson's Fatigue Scale 16.
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- XWPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel M. Canafax, PharmD, Study director, XWPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056194
- Sponsor's protocol ID
- XW10172-104
- Status last verified
- Mar 2025
- First submitted
- 17 Sep 2021
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05056194
- Acronym / sponsor ID
- XW10172-104
- Conditions
- Parkinson Disease, Excessive Daytime Somnolence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- XWPharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valiloxybate | Experimental | Drug: ValiloxybateXW10172 Modified Release (MR) Granules for Oral Suspension |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Granules for Oral Suspension |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValiloxybateAlso: XW10172 MRXW10172 MR Granules for Oral Suspension | Drug | Valiloxybate |
| PlaceboPlacebo Granules for Oral Suspension | Other | Placebo |
Primary outcome
Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Epworth Sleepiness Scale.
Time frame: 6 weeks
4 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel M. Canafax, PharmD study director
XWPharma
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valiloxybate in people with Parkinson Disease and Excessive Daytime Somnolence, run by XWPharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between XW10172 MR and placebo in the change from baseline to end-of-maintenance in the Epworth Sleepiness Scale. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.