Parkinson DiseaseEarly Phase 1NCT05796167
Pimavanserin for Sleep in Parkinson Disease
A Early Phase 1 study testing Pimavanserin in people with Parkinson Disease, run by State University of New York - Downstate Medical Center at 1 site in United States.
Trial summary
This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Pimavanserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2023to 24 Jun 2024
- Phase
- Early Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diagnosis of idiopathic PD according to UK (United Kingdom) PD Society Brain Bank diagnostic criteria
- Has a history of hallucinations or delusions associated with PD
- Has a history of sleep disturbance
- Is between the ages of 40 and 85
- Has been on a stable dose of all PD medications for at least 30 days prior to enrolment
Who cannot join
- Has evidence of an atypical or secondary parkinsonian disorder
- Has a contraindication to taking pimavanserin
- Has contraindication to PSG
- There has been a change to patient's neuropsychiatric medications including dopaminergic medications (Sinemet, dopamine agonists, MAO(monoamine oxidaze)-B inhibitors), SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), dopamine-blocking agents, anti-epileptics, anticholinergics, or benzodiazepines for at least 30 days prior to enrollment
- Has traveled through 3 or more time zones within 60 days prior to study screening
- Patient is a night-shift worker
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Downstate Health Sciences University
Brooklyn, New York, 11203
About this study
Official title: Does Pimavanserin (Nuplazid) Improve Sleep in Patients With Parkinson Disease Psychosis? A Pilot Study
This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.
Read the detailed description
This is a feasibility study to determine whether pimavanserin improves sleep quality in patients with PD and visual hallucinations/delusions.
Patients will complete a Screening Visit to assess eligibility to participate in the study.
For more information, please contact Sofya Glazman, a study coordinator, at sofya.glazman@downstate.edu
- Conditions
- Parkinson Disease
- Being tested
- Pimavanserin
- Keywords
- sleep, visual hallucinations, delusions
- Medical subject headings
- Parkinson Disease, Hallucinations, Delusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimavanserinDrug
Also called Nuplazid
Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pimavanserin (Nuplazid) | Experimental | Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks for patients with Parkinson disease psychosis (e.g., visual hallucinations, delusions) and sleep problems Receives: Drug: Pimavanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of pimavanserin on sleep fragmentation
Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography
Measured: 6 weeks
Secondary outcomes (8)
Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder
Presence fo REM sleep without atonia (RWA) on polysomnograophy
Measured: 6 weeks
Effect of pimavanserin on sleep latency
Time to first epoch on polysomnography
Measured: 6 weeks
Effect of pimavanserin on total sleep time
Total sleep time measured on polysomnography
Measured: 6 weeks
Effect of pimavanserin on sleep efficiency
Sleep Efficiency Index in percent is the ratio of total sleep time (based on polysomnography recordings) to time in bed
Measured: 6 weeks
Effect of pimavanserin on time in each sleep stage
Time in each sleep stage as measured on polysomnography
Measured: 6 weeks
Effect of pimavanserin on subjective measure of REM Sleep behavior disorder
RBDSQ (REM (Rapid Eye Movements) Sleep Behavior Disorder Screening Questionnaire to assess the most prominent clinical features of RBD. It is a 10-item, patient self-rating instrument with short questions to be answered by either 'yes' or 'no'.
Measured: 6 weeks
Effect of pimavanserin on subjective measures of sleep
PDSS-2 (Parkinson's Disease Sleep Scale Version 2) total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Scores > 18 are considered as relevant sleep disturbances
Measured: 6 weeks
Effect of pimavanserin on subjective measures of fatigue
PFS-16 (Parkinson's disease Fatigue Scale): 16-item scale with the following scoring for each item: strong disagree -1, disagree - 2, neither agree or disagree - 3, agree - 4, strongly agree - 5; with overall score of ≥8 indicates the presence of significant fatigue.
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 posted3 Apr 2023
- Study start27 Jan 2023
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Why it stopped: The PI did not have eligible candidates. Therefore, Acadia Pharmaceuticals (the sponsor) closed the study.
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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- self-control, pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ACADIA Pharmaceuticals Inc.
- Responsible party
- Sponsor
- Investigators
- Christian J Amlang, MD, Principal investigator, State University of New York - Downstate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796167
- Sponsor's protocol ID
- 22-02-723-205
- Other IDs
- 1396075255
- Status last verified
- Dec 2024
- First submitted
- 31 Jan 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pimavanserin (Nuplazid) Improve Sleep in Patients With Parkinson Disease Psychosis? A Pilot Study
- ClinicalTrials.gov ID
- NCT05796167
- Acronym / sponsor ID
- 22-02-723-205
- Conditions
- Parkinson Disease
- Keywords
- sleep, visual hallucinations, delusions
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI did not have eligible candidates. Therefore, Acadia Pharmaceuticals (the sponsor) closed the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Collaborators
- ACADIA Pharmaceuticals Inc.
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 3 Apr 2023 (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.
This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.
Detailed description
This is a feasibility study to determine whether pimavanserin improves sleep quality in patients with PD and visual hallucinations/delusions.
Patients will complete a Screening Visit to assess eligibility to participate in the study.
For more information, please contact Sofya Glazman, a study coordinator, at sofya.glazman@downstate.edu
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- self-control, pilot study
| Arm | Type | Receives |
|---|---|---|
| Pimavanserin (Nuplazid) | Experimental | Drug: PimavanserinPimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks for patients with Parkinson disease psychosis (e.g., visual hallucinations, delusions) and sleep problems |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a diagnosis of idiopathic PD according to UK (United Kingdom) PD Society Brain Bank diagnostic criteria
- Has a history of hallucinations or delusions associated with PD
- Has a history of sleep disturbance
- Is between the ages of 40 and 85
- Has been on a stable dose of all PD medications for at least 30 days prior to enrolment
Key exclusion criteria (6 listed)
- Has evidence of an atypical or secondary parkinsonian disorder
- Has a contraindication to taking pimavanserin
- Has contraindication to PSG
- There has been a change to patient's neuropsychiatric medications including dopaminergic medications (Sinemet, dopamine agonists, MAO(monoamine oxidaze)-B inhibitors), SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), dopamine-blocking agents, anti-epileptics, anticholinergics, or benzodiazepines for at least 30 days prior to enrollment
- Has traveled through 3 or more time zones within 60 days prior to study screening
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 |
|---|---|---|
| PimavanserinAlso: NuplazidPimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks | Drug | Pimavanserin (Nuplazid) |
Primary outcome
Effect of pimavanserin on sleep fragmentation
Time frame: 6 weeks
Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography
8 secondary outcomes
Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder
Time frame: 6 weeks
Effect of pimavanserin on sleep latency
Time frame: 6 weeks
Effect of pimavanserin on total sleep time
Time frame: 6 weeks
Effect of pimavanserin on sleep efficiency
Time frame: 6 weeks
Effect of pimavanserin on time in each sleep stage
Time frame: 6 weeks
Effect of pimavanserin on subjective measure of REM Sleep behavior disorder
Time frame: 6 weeks
Effect of pimavanserin on subjective measures of sleep
Time frame: 6 weeks
Effect of pimavanserin on subjective measures of fatigue
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 20 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Christian J Amlang, MD principal investigator
State University of New York - Downstate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pimavanserin in people with Parkinson Disease, run by State University of New York - Downstate Medical Center at 1 site in United States.
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 6 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 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Effect of pimavanserin on sleep fragmentation (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 20 Dec 2024.