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To assess the effect of pimavanserin on the activities of daily living in subjects with Parkinson's Disease Psychosis
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug - Pimavanserin | Experimental | Pimavanserin 34 mg administered orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimavanserin | Drug | Pimavanserin 34 mg (provided as 1×34 mg capsule), administered orally, once daily for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 16 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Movement Disorders Center of Arizona | Scottsdale | Arizona | 85258 | United States | ||
| Neurology Center of North Orange County |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38476466 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pimavanserin 34 mg | Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2021 | Jun 12, 2023 |
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| 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. | 16 Weeks |
| 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 | 16 Weeks |
| 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. | 16 Weeks |
| 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. | 16 Weeks |
| Fullerton |
| California |
| 92835 |
| United States |
| Premier Clinical Research Institute, Inc. | Miami | Florida | 33122 | United States |
| Global Health Research Center, Inc. | Miami Lakes | Florida | 33016 | United States |
| Quantum Laboratories, Inc. | Pompano Beach | Florida | 33064 | United States |
| Parkinson's Disease Treatment Center of Southwest Florida | Port Charlotte | Florida | 33980 | United States |
| Accel Research Sites - Brain and Spine Institute | Port Orange | Florida | 32127 | United States |
| Infinity Clinical Research, LLC | Sunrise | Florida | 33351 | United States |
| Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | 33407 | United States |
| AU Movement and Memory Disorders | Augusta | Georgia | 30912 | United States |
| Maine Medical Partners Neurology | Scarborough | Maine | 04074 | United States |
| Wentworth Health Partners Coastal Neurology Services | Dover | New Hampshire | 03820 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| Neurology Diagnostics, Inc. | Dayton | Ohio | 45459 | United States |
| The Orthopedic Foundation | New Albany | Ohio | 43054 | United States |
| Central States Research | Tulsa | Oklahoma | 74136 | United States |
| KCA Neurology | Franklin | Tennessee | 37067 | United States |
| Neurological Associates of North Texas | Dallas | Texas | 75218 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pimavanserin 34 mg | Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients enrolled and with baseline mFSQ value | Posted | Least Squares Mean | Standard Error | score on a scale | 16 weeks |
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| Secondary | 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" | All patients enrolled and with baseline mFSQ value | Posted | Least Squares Mean | Standard Error | score on a scale | 16 Weeks |
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| Secondary | 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. | All patients enrolled and with baseline mFSQ value | Posted | Least Squares Mean | Standard Error | score on a scale | 16 Weeks |
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| Secondary | 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 | All patients enrolled and with baseline mFSQ value | Posted | Least Squares Mean | Standard Error | score on a scale | 16 Weeks |
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| Secondary | 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. | All patients enrolled and with baseline mFSQ value | Posted | Least Squares Mean | Standard Error | score on a scale | 16 Weeks |
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| Secondary | 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. | All patients enrolled and with baseline mFSQ value | Posted | Least Squares Mean | Standard Error | score on a scale | 16 Weeks |
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From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pimavanserin 34 mg | Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily | 0 | 29 | 3 | 29 | 9 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Inflammation | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 23.0 | Non-systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | MedDRA 23.0 | Non-systematic Assessment |
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Investigator may publish the study results, relative to his/her own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the sponsor for review and comment. The sponsor has 60 days to review and comment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Dir. Medical Information and Medical Communications | ACADIA Pharmaceuticals Inc. | +1-858-261 | 2897 | medicalinformation@acadia-pharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2022 | Jun 12, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C510793 | pimavanserin |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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