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This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | Pimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks |
|
| 3 | Experimental | Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks |
|
| 1 | Placebo Comparator | Placebo tablet, once daily by mouth, 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimavanserin tartrate (ACP-103) | Drug | 10 mg, tablet, once daily by mouth, 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Antipsychotic Efficacy | Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 0 to 100 and a negative change in score indicates improvement. Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method. | Each study visit (i.e. Days 1, 8, 15, 29 and 42) |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Symptoms Change From Baseline (Negative = Improvement) | Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination) using the per-protocol (PP) analysis set. The possible total score is 0 to 160 and a negative change in score indicates improvement. Analysis Method: ANCOVA, and missing data was imputed using LOCF. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5. |
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Inclusion Criteria:
Exclusion Criteria:
Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gilbert | Arizona | 85234 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo tablet, once daily by mouth, 6 weeks |
| FG001 | Pimavanserin 10 mg | Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Pimavanserin tartrate (ACP-103) |
| Drug |
40 mg, tablet, once daily by mouth, 6 weeks |
|
| Placebo | Drug | tablet, once daily by mouth, 6 weeks |
|
| Each study visit (i.e. Days 1, 8, 15, 29 and 42) |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Berkeley | California | 94705 | United States |
| Carson | California | 90746 | United States |
| Fountain Valley | California | 92708 | United States |
| Irvine | California | 92697 | United States |
| Sunnyvale | California | 94805 | United States |
| Danbury | Connecticut | 06810 | United States |
| Fairfield | Connecticut | 06824 | United States |
| Boca Raton | Florida | 33486 | United States |
| Gainesville | Florida | 32610 | United States |
| Jacksonville | Florida | 32209 | United States |
| Miami | Florida | 33136 | United States |
| Pompano Beach | Florida | 33060 | United States |
| Port Charlotte | Florida | 33952 | United States |
| Sarasota | Florida | 34239 | United States |
| St. Petersburg | Florida | 33701 | United States |
| Tampa | Florida | 33606 | United States |
| Augusta | Georgia | 30912 | United States |
| Springfield | Illinois | 62794 | United States |
| Scarborough | Maine | 04074 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Southfield | Michigan | 48034 | United States |
| Traverse City | Michigan | 49684 | United States |
| Toms River | New Jersey | 08755 | United States |
| Kingston | New York | 12401 | United States |
| Rochester | New York | 14618 | United States |
| Asheville | North Carolina | 28806 | United States |
| Salisbury | North Carolina | 28144 | United States |
| Columbus | Ohio | 43210 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Brentwood | Tennessee | 37027 | United States |
| San Antonio | Texas | 78258 | United States |
| Richmond | Virginia | 23229 | United States |
| Kirkland | Washington | 98034 | United States |
| Spokane | Washington | 99204 | United States |
| Pleven | 5800 | Bulgaria |
| Rousse | 7003 | Bulgaria |
| Sofia | 1113 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Clermont-Ferrand | 63003 | France |
| Marseille | 13385 | France |
| Nantes | 44093 | France |
| Pessac | 33604 | France |
| Strasbourg | 67091 | France |
| Toulouse | 35059 | France |
| Bangalore | 560034 | India |
| Hyderabad | 500003 | India |
| Karnataka | 575001 | India |
| Mangalore | 575002 | India |
| Mumbai | 400016 | India |
| Mumbai | 400036 | India |
| New Dalhi | 110060 | India |
| Pune | 411004 | India |
| Pune | 411030 | India |
| Tamil Nadu | 600006 | India |
| Tamil Nadu | 625020 | India |
| Visakhapatnam | 530001 | India |
| Kazan' | 420061 | Russia |
| Kirov | 610014 | Russia |
| Moscow | 125284 | Russia |
| Saint Petersburg | 194044 | Russia |
| Samara | 443095 | Russia |
| Smolensk | 214018 | Russia |
| Kharkiv | 61068 | Ukraine |
| Kiev | 04080 | Ukraine |
| Kiev | 04114 | Ukraine |
| Luhansk | 91045 | Ukraine |
| Lviv | 79010 | Ukraine |
| Vinnytsia | 21005 | Ukraine |
| Barnsley | S75 2EP | United Kingdom |
| Blackburn | BB3 2HH | United Kingdom |
| Brighton | BN2 5BE | United Kingdom |
| Dorset | BH23 2JX | United Kingdom |
| London | NW3 2PF | United Kingdom |
| Newcastle upon Tyne | NE4 6BE | United Kingdom |
| North Shields | NE29 8NH | United Kingdom |
| Salford | M6 8HD | United Kingdom |
| FG002 | Pimavanserin 40 mg | Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo tablet, once daily by mouth, 6 weeks |
| BG001 | Pimavanserin 10 mg | Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks |
| BG002 | Pimavanserin 40 mg | Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Antipsychotic Efficacy | Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 0 to 100 and a negative change in score indicates improvement. Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method. | This is the "Intent to Treat" population, defined as patients who received at least one dose of study drug, and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on the SAPS H+D scale | Each study visit (i.e. Days 1, 8, 15, 29 and 42) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Motor Symptoms Change From Baseline (Negative = Improvement) | Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination) using the per-protocol (PP) analysis set. The possible total score is 0 to 160 and a negative change in score indicates improvement. Analysis Method: ANCOVA, and missing data was imputed using LOCF. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5. | This is the "Per Protocol" population, which includes subjects in the ITT analysis set, who were free of important protocol deviations, as defined before database lock and unblinding. Subjects were analyzed according to the treatment actually received. | Posted | Least Squares Mean | 95% Confidence Interval | Score on UPDRS-II+III | Each study visit (i.e. Days 1, 8, 15, 29 and 42) |
|
6 weeks
From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 8, 15, 29, 42 and Day 70 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
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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 | Placebo | Placebo tablet, once daily by mouth, 6 weeks | 2 | 98 | 34 | 98 | ||
| EG001 | Pimavanserin 10 mg | Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks | 5 | 99 | 29 | 99 | ||
| EG002 | Pimavanserin 40 mg | Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks | 5 | 98 | 27 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dementia | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Inguinal hernia repair | Surgical and medical procedures | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Edema | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
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 | |
|---|---|---|---|---|
| Roger Mills, MD | ACADIA Pharmaceuticals Inc. | 858-202-7563 | rmills@acadia-pharm.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C510793 | pimavanserin |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| India |
|
| Europe |
|
| Difference of Least Squares Mean versus Placebo |
|
| Pimavanserin 40 mg |
Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks |
|
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