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Parkinson Disease PsychosisPhase 4NCT04292223

Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis

A Phase 4 study testing Pimavanserin in people with Parkinson Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the effect of pimavanserin on the activities of daily living in subjects with Parkinson's Disease Psychosis Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Parkinson Disease Psychosis
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
29 participants
Where
18 sitesUnited States
Study dates
10 Feb 2020to 26 Apr 2022
Phase
Phase 4
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects at least 40 years of age
  • Has a Mini-Mental State Examination (MMSE) score ≥19 at Screening
  • Has a diagnosis of idiopathic Parkinson's disease (PD)
  • Has psychotic symptoms that may impair function and are severe enough to warrant treatment with an antipsychotic agent
  • Psychotic symptoms developed after the onset of symptoms of PD
  • If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) OR must agree to use TWO clinically acceptable methods of contraception.

Who cannot join

  • Has atypical parkinsonism (Parkinson's plus, multiple system atrophy [MSA], progressive supranuclear palsy [PSP]), or secondary parkinsonism variants such as tardive or medication induced parkinsonism
  • Has undergone ablative procedures such as a pallidotomy, thalamotomy, or treatment with focused ultrasound, or has an implanted deep brain stimulator
  • 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 history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident within the last 6 months prior to Screening
  • Has any of the following:
  • greater than New York Heart Association (NYHA) Class 2 congestive heart failure
Show all 21Show fewer
  • Grade 2 or greater angina pectoris (by Canadian Cardiovascular Society Angina Grading Scale)
  • sustained ventricular tachycardia
  • ventricular fibrillation
  • torsades de pointes
  • syncope due to an arrhythmia
  • an implantable cardiac defibrillator
  • Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
  • Requires treatment with a medication or other substance that is prohibited by the protocol
  • Has a body mass index (BMI) <18.5 kg/m2 or >35 kg/m2 at Screening or Baseline or known unintentional clinically significant weight loss (i.e., ≥7%) over past 6 months
  • Is suicidal at Screening or Baseline
  • Has a history of a significant psychotic disorder prior to or concomitantly with the onset of PD including, but not limited to, schizophrenia or bipolar disorder
  • Had dementia prior to or concomitantly with the onset of motor symptoms of PD
  • Positive COVID-19 polymerase chain reaction (PCR) or antigen result in the last 2 weeks prior to screening
  • Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
  • Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • AU Movement and Memory Disorders

    Augusta, Georgia, 30912

  • Neurological Associates of North Texas

    Dallas, Texas, 75218

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459

  • Wentworth Health Partners Coastal Neurology Services

    Dover, New Hampshire, 03820

  • KCA Neurology

    Franklin, Tennessee, 37067

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Premier Clinical Research Institute, Inc.

    Miami, Florida, 33122

  • Global Health Research Center, Inc.

    Miami Lakes, Florida, 33016

  • The Orthopedic Foundation

    New Albany, Ohio, 43054

  • Quantum Laboratories, Inc.

    Pompano Beach, Florida, 33064

  • Parkinson's Disease Treatment Center of Southwest Florida

    Port Charlotte, Florida, 33980

  • Accel Research Sites - Brain and Spine Institute

    Port Orange, Florida, 32127

  • Maine Medical Partners Neurology

    Scarborough, Maine, 04074

  • Movement Disorders Center of Arizona

    Scottsdale, Arizona, 85258

  • Infinity Clinical Research, LLC

    Sunrise, Florida, 33351

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Central States Research

    Tulsa, Oklahoma, 74136

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: A 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis

To assess the effect of pimavanserin on the activities of daily living in subjects with Parkinson's Disease Psychosis

Read the detailed description

This study will be conducted as a 16-week, multi-center, single-arm, open-label study. Pimavanserin will be administered at a dose of 34 mg to approximately 50 subjects with PDP

Being tested
Pimavanserin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PimavanserinDrug

    Also called NUPLAZID

    Pimavanserin 34 mg (provided as 1×34 mg capsule), administered orally, once daily for 16 weeks

Study groups in NCT04292223
Study groupRoleWhat they receive
Drug - PimavanserinExperimentalPimavanserin 34 mg administered orally
Receives: Drug: Pimavanserin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total Score

    The mFSQ is a self-administered questionnaire. It comprises 34 core items that produce 6 summary scale scores (i.e. basic activities of daily living (ADL); intermediate ADL; psychological function and mental health; work performance, social activity, and quality of interaction) and 6 single-item scores (work situation; days/month in bed due to illness/injury; days/month when illness/injury reduced activities normally performed for half a day; satisfaction with sexual relationship; satisfaction with health; frequency of social interaction).

    The mFSQ is calculated as the unweighted mean of predefined subscale scores. The maximum mFSQ total score is 100, with higher scores indicating better functional status. The minimum score is 0 and the maximum score is 100.

    Measured: 16 weeks

Secondary outcomes (5)

  1. Change From Baseline to Week 16 on the Schwab and England Activity of Daily Living (ADL) Scale, Caregiver and Patient Versions

    The Schwab \& England ADL Scale is a scale ranging from 0% to 100% scale with 10% intervals, where 100% is "Completely independent. Unaware of difficulty" and 0% is "Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden"

    Measured: 16 Weeks

  2. Change From Baseline to Week 16 on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II

    The MDS-UPDRS is a battery of motor and behavioral indices. MDS-UPDRS Part I assesses non-motor aspects of experiences of daily living (EDL) and consists of 13 items (6 investigator assessed; 7 patient assessed, each scored on a 5-point Likert scale). The total score is the sum of the 13 individual items. The highest score is 52, higher scores mean more severe impact of the disease on non-motor aspects of ADL and the lowest score is 0. In Part 1, a lower score is better while a higher score is worse.

    Part II assesses motor aspects of EDL and consists of 13 items (all patient assessed, each on a 5-point Likert scale). The highest score is 52, higher scores mean more severe impact of the disease on motor aspects of ADL and the lowest score is 0. In Part 2, a lower score is better while a higher score is worse.

    Measured: 16 Weeks

  3. Week 16 Clinical Global Impression - Improvement (CGI-I) Score for Hallucinations and Delusions

    The CGI-I is a clinician-rated, 7-point scale to rate the improvement in patient symptoms at the time of assessment, relative to the symptoms at baseline. Severity ratings are based on the behavioral domains of hallucinations and delusions. The score ranges from 1=very much improved to 7=very much worse. Higher scores denote more severe symptoms of hallucinations and delusions

    Measured: 16 Weeks

  4. Change From Baseline to Week 16 on the Clinical Global Impression - Severity of Illness (CGI-S) Score for Hallucinations and Delusions

    The CGI-S scale is a clinician-rated, 7-point scale to rate the severity of patient neuropsychiatric symptoms at the time of assessment using the Investigator's judgment and past experience with patients who have the same disorder. Severity ratings aree based on the behavioral domains of hallucinations and delusions.The score ranges from 1=normal, not at all ill to 7=among the most extremely ill patients. Higher scores denote more severe symptoms of hallucinations and delusions.

    Measured: 16 Weeks

  5. Patient Global Impression of Improvement (PGI-I) Score for Hallucinations and Delusions at Week 16

    The PGI-I is a global index to rate the response of a condition to a therapy. Patients have to rate their current symptoms, compared with baseline. Responses range from 1=very much better to 7=very much worse. Severity ratings are based on the behavioral domains of hallucinations and delusions.

    Measured: 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2020
  2. Study start10 Feb 2020
  3. Primary completion26 Apr 2022
  4. Study completion26 Apr 2022

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04292223
Sponsor's protocol ID
ACP-103-063
Status last verified
Dec 2024
First submitted
28 Feb 2020
Last updated
14 Jan 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Evidente VGH, DeKarske D, Coate B, Abler V. The effects of treatment with pimavanserin on activities of daily living in patients with Parkinson's disease psychosis: a 16-week, single-arm, open-label study. Ther Adv Neurol Disord. 2024 Mar 11;17:17562864241228350. doi: 10.1177/17562864241228350. eCollection 2024.

    PubMed 38476466

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pimavanserin in people with Parkinson Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 18 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 6 inclusion and 21 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: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Jan 2025). 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?

Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total Score (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04292223, which also lists 1 linked publication.

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 Jan 2025.

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