Parkinson's DiseasePhase 2NCT04164758
Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
A Phase 2 study testing Pimavanserin and Quetiapine in people with Parkinson's Disease, run by ACADIA Pharmaceuticals Inc. at 16 sites in United States.
Trial summary
This is a pilot study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Pimavanserin and Quetiapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 16 sitesUnited States
- Study dates
- 23 Oct 2019to 25 Sep 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 50 to 85 years of age, inclusive
- Able to understand the protocol requirements and provide written informed consent
- Able to complete questions on a handheld device / tablet, is willing to wear an actigraph and can be reliably rated on assessment scales
- Able to designate an 'informant' (relative, housemate, friend) who can provide information about the subject's well being and attend clinic visits with the subject
- Is able to swallow the test capsule without difficulty during the Screening visit
- Has a Mini-Mental State Examination (MMSE) score ≥19
Show all 10Show fewer
- Has a diagnosis of idiopathic Parkinson's disease, without any other known or suspected cause of parkinsonism. Initial diagnosis of PD must have been made more than 1 year prior to Screening.
- Has non-motor neuropsychiatric symptoms severe enough to warrant treatment with an antipsychotic agent based on investigator judgement and CGI-S score
- If the subject is on anti-Parkinsonian medication, they must be on a stable regimen for 1 month prior to Baseline and not planning (at the time of the Baseline visit) to make a major change in dose(s)
- If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential or must agree to use a clinically acceptable method of contraception or be abstinent for at least 1 month prior to the Baseline visit, during the study, and 41 days following completion of double-blind treatment.
Who cannot join
- Has atypical parkinsonism or secondary parkinsonism variants such as tardive or medication induced parkinsonism
- Is in hospice, is receiving end-of-life palliative care, or is bedridden or confined to a wheelchair
- Has neuropsychiatric symptoms that are primarily attributable to current delirium or substance abuse
- Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or psychiatric disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
- Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
- Has orthostatic hypotension as judged by the investigator and medical monitor
- Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason, including if the subject is judged to be a danger to self or others
- Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all pre-specified entry criteria).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459
Prisma Health-Upstate
Greenville, South Carolina, 29615
Galiz Research
Hialeah, Florida, 30016
Hawaii Pacific Neuroscience, LLC.
Honolulu, Hawaii, 96817
University of lowa Hospital and Clinics
Iowa City, Iowa, 52242
Charter Research, LLC
Lady Lake, Florida, 32159
Premier Clinical Research Institute, Inc.
Miami, Florida, 33122
SRI International
Plymouth, Michigan, 48170
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
Sutter Institute for Medical Research
Sacramento, California, 95816
Meridian Clinical Research
Savannah, Georgia, 31406
Movement Disorders Center of Arizona
Scottsdale, Arizona, 85258
Infinity Clinical Research, LLC
Sunrise, Florida, 33351
Bio Behavioral Health
Toms River, New Jersey, 08755
Tucson Neuroscience Research
Tucson, Arizona, 85710
Charter Research, LLC
Winter Park, Florida, 32792
About this study
Official title: A Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
This is a pilot study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms.
- Conditions
- Parkinson's Disease
- Being tested
- Pimavanserin, Placebo, Quetiapine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimavanserinDrug
Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily
PlaceboOther
Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily
QuetiapineDrug
Quetiapine 25 mg (provided as 1×25 mg quetiapine encapsulated tablet and 1 × placebo encapsulated tablet), OR 50 mg (provided as 2×25 mg quetiapine encapsulated tablets), OR 100 mg (provided as 2×50 mg quetiapine encapsulated tablets) administered orally as a single dose once daily
| Study group | Role | What they receive |
|---|---|---|
| Drug - pimavanserin | Experimental | Pimavanserin 34 mg provided as 2 x 17 mg encapsulated tablets Receives: Drug: Pimavanserin |
| Placebo | Placebo comparator | Placebo encapsulated tablet Receives: Other: Placebo |
| Quetiapine | Active comparator | Immediate release Quetiapine encapsulated tablets Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent Adverse Events (TEAEs)
Assess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events.
Measured: 4-week treatment duration, plus 30 days treatment-free safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start23 Oct 2019
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
Why it stopped: Study enrollment impacted by COVID-19 pandemic and Sponsor terminated for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164758
- Sponsor's protocol ID
- ACP-103-056
- Status last verified
- Sep 2021
- First submitted
- 13 Nov 2019
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
- ClinicalTrials.gov ID
- NCT04164758
- Acronym / sponsor ID
- ACP-103-056
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrollment impacted by COVID-19 pandemic and Sponsor terminated for business reasons
- Enrolment
- 11 participants (actual)
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Posted 14 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug - pimavanserin | Experimental | Drug: PimavanserinPimavanserin 34 mg provided as 2 x 17 mg encapsulated tablets |
| Placebo | Placebo comparator | Other: PlaceboPlacebo encapsulated tablet |
| Quetiapine | Active comparator | Drug: QuetiapineImmediate release Quetiapine encapsulated tablets |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects 50 to 85 years of age, inclusive
- Able to understand the protocol requirements and provide written informed consent
- Able to complete questions on a handheld device / tablet, is willing to wear an actigraph and can be reliably rated on assessment scales
- Able to designate an 'informant' (relative, housemate, friend) who can provide information about the subject's well being and attend clinic visits with the subject
- Is able to swallow the test capsule without difficulty during the Screening visit
Key exclusion criteria (8 listed)
- Has atypical parkinsonism or secondary parkinsonism variants such as tardive or medication induced parkinsonism
- Is in hospice, is receiving end-of-life palliative care, or is bedridden or confined to a wheelchair
- Has neuropsychiatric symptoms that are primarily attributable to current delirium or substance abuse
- Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or psychiatric disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
- Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
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 |
|---|---|---|
| PimavanserinPimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily | Drug | Drug - pimavanserin |
| PlaceboPlacebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily | Other | Placebo |
| QuetiapineQuetiapine 25 mg (provided as 1×25 mg quetiapine encapsulated tablet and 1 × placebo encapsulated tablet), OR 50 mg (provided as 2×25 mg quetiapine encapsulated tablets), OR 100 mg (provided as 2×50 mg quetiapine encapsulated tablets) administered orally as a single dose once daily | Drug | Quetiapine |
Primary outcome
Treatment-emergent Adverse Events (TEAEs)
Time frame: 4-week treatment duration, plus 30 days treatment-free safety follow-up
Assess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pimavanserin and Quetiapine in people with Parkinson's Disease, run by ACADIA Pharmaceuticals Inc. at 16 sites 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 10 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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. 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?
Yes. Results are posted in the registry (first posted 14 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment-emergent Adverse Events (TEAEs) (time frame: 4-week treatment duration, plus 30 days treatment-free safety follow-up). 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 14 Oct 2021.