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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003536-36 | EudraCT Number |
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The purpose of this study is to assess the safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug - Pimavanserin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimavanserin | Drug | Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events (TEAEs) | Number (%) of patients with treatment-emergent AEs | Treatment Period: 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) | The ESRS is a questionnaire to assess drug induced movement disorders, including parkinsonism; the ESRS-A is an accepted modified form of the original ESRS. The ESRS-A consists of 4 subscales and 4 clinical global impression movement severity scales of Parkinsonism, dyskinesia, dystonia, and akathisia. The Parkinsonism scale consists of 10 items, the dyskinesia subscale of 6 items, the dystonia subscale of 6 items, and the akathisia subscale of 2 items. Each item is scored on a 6-point scale from 0 (absent) to 5 (extreme). The ESRS-A total score is the sum of the 24 item scores with a possible range of 0 to 120. Higher scores denote more severe drug-induced movement disorders. |
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Inclusion Criteria:
Can understand the nature of the trial and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:
Subject requires some or complete assistance with one or more of the following:
Meets clinical criteria for at least one of the following disorders, with or without cerebrovascular disease (CVD):
i. Behavioral variant frontotemporal dementia
ii. Progressive supranuclear palsy
iii. Corticobasal degeneration
e. Vascular dementia, including post-stroke dementia multi-infarct dementia and/or subcortical ischemic vascular dementia (SIVD)
Has a designated study partner/caregiver
Can come to the clinic for study visits with a study partner/caregiver
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 a clinically acceptable method of contraception or be abstinent.
If the subject is taking an antipsychotic medication at the time of screening, the antipsychotic medication must be discontinued 2 weeks or 5 half-lives (whichever is longer)
Exclusion Criteria:
Is in hospice, is receiving end-of-life palliative care, or is bedridden
Has psychotic symptoms that are primarily attributable to delirium or substance abuse (i.e., neuropsychiatric symptoms not related to neurodegenerative disease)
Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical 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 a clinical significant CNS abnormality that is most likely contributing to the dementia or findings on MRI or CT including:
The urine drug screen result at Visit 1 (Screening) indicates the presence of amphetamine/methamphetamine, barbiturates, cocaine, or phencyclidine (PCP). Subjects who test positive for amphetamines and who have a valid prescription may be retested if they agree to abstain from the medication for the length of their participation in the study. The presence of benzodiazepines, marijuana (THC), or opiates does not necessarily exclude the subject from the study, as assessed by the Investigator in consultation with the Medical Monitor.
Has previously been enrolled in any prior clinical study with pimavanserin or is currently taking pimavanserinIs judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
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 psychiatric condition do not meet all pre-specified entry criteria).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognitive Clinical Trials | Gilbert | Arizona | 85296 | United States | ||
| ATP Clinical Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38427485 | Derived | Alva G, Cubala WJ, Berrio A, Coate B, Abler V, Pathak S. Safety Profile of Pimavanserin Therapy in Elderly Patients with Neurodegenerative Disease-Related Neuropsychiatric Symptoms: A Phase 3B Study. J Alzheimers Dis. 2024;98(1):265-274. doi: 10.3233/JAD-231167. |
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This was a multicenter study in adult and elderly patients with neuropsychiatric symptoms related to neurodegenerative disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Pimavanserin matching placebo (administered as 2 capsules) once daily |
| FG001 | Pimavanserin 34 mg | Pimavanserin 34 mg (administered as 2 x 17 mg capsules) 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 | Mar 5, 2021 | Nov 22, 2024 |
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| Placebo | Drug | Placebo, tablets, once daily by mouth (provided as two placebo tablets) |
|
| Treatment Period: 8 weeks |
| Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE) | The MMSE is a 30-item questionnaire to quantitatively assess cognition, focusing on questions related to time and place of testing, repeating lists of words, arithmetic, language use and comprehension, and copying a drawing. Each of the 30 items has 2 possible values of 0 (incorrect) or 1 (correct). The MMSE total score is derived as the sum of the 30 item scores; thus, it can range from 0 to 30. Lower scores indicate more severe cognitive impairment. | Treatment Period: 8 weeks |
| Costa Mesa |
| California |
| 92626 |
| United States |
| Syrentis Clinical Research | Santa Ana | California | 92705 | United States |
| Indago Research & Health Center Inc | Hialeah | Florida | 33012 | United States |
| Reliable Clinical Research, LLC | Hialeah | Florida | 33012 | United States |
| Axcess Medical Research | Loxahatchee Groves | Florida | 33470 | United States |
| Premier Clinical Research Institute, Inc. | Miami | Florida | 33122 | United States |
| Global Medical Institutes | Miami | Florida | 33125 | United States |
| Future Care Solution, LLC | Miami | Florida | 33165 | United States |
| MediClear Medical & Research Center, Inc. | Miami | Florida | 33165 | United States |
| Novel Clinical Research LLC | Miami | Florida | 33186 | United States |
| Laszlo J Mate, MD, PA | North Palm Beach | Florida | 33408 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Synexus Clinical Research US | The Villages | Florida | 32162 | United States |
| Boston Center Memory | Newton | Massachusetts | 02459 | United States |
| Cognitive Clinical Trials LLC | Papillion | Nebraska | 68046 | United States |
| The NeuroCognitive Institute | Mount Arlington | New Jersey | 07856 | United States |
| UNC Hospital | Chapel Hill | North Carolina | 27599 | United States |
| Insight Clinical Trials LLC | Shaker Heights | Ohio | 44122 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Central for Biomedical Research, LLC | Knoxville | Tennessee | 37909 | United States |
| Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero | Burgas | 8000 | Bulgaria |
| UMHAT Psych clin for gen psychiatry and addictions | Pleven | 5800 | Bulgaria |
| DCC Sv. Vrach and Sv. Sv. Kozma and Damyan | Sofia | 1408 | Bulgaria |
| Diagnostic Consultative Centre, 2, N. Vaptzarov Street | Varna | 9000 | Bulgaria |
| Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd | Varna | 9000 | Bulgaria |
| Mental Health Center Vratza EOOD, 1 Belasitsa St | Vratsa | 3000 | Bulgaria |
| E.S.E. Hospital Mental de Antioquia | Bello | Antioquia | 51053 | Colombia |
| Centr Investigaciones y Proyectos en Neurociencias | Barranquilla | Atlántico | 080020 | Colombia |
| Psynapsis Salud Mental S.A. | Pereira | Risaralda Department | 66001 | Colombia |
| Centro de Investigaciones del Sistema Nervioso | Bogotá | 111166 | Colombia |
| BRAIN-SOULTHERAPY s.r.o., , Lekarna Jalta, Namesti Jana Masaryka 3113 | Kladno | 27204 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 77900 | Czechia |
| A-shine s.r.o./ Lekarna Centrum | Pilsen | 31200 | Czechia |
| AD71, s.r.o.,/Hostivarska Iekarna | Prague | 10200 | Czechia |
| Axon Clinical | Prague | 1500 | Czechia |
| Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1 | Prague | 16010 | Czechia |
| AD71, s.r.o., /,Lekarna DPS Recruiting | Říčany | 25101 | Czechia |
| Petre Sarajishvili Institute of Neurology LLC | Tbilisi | 0112 | Georgia |
| Pineo Medical Ecosystem LTD | Tbilisi | 0114 | Georgia |
| Tbilisi Heart and Vascular Clinic LTD | Tbilisi | 0159 | Georgia |
| Health Institute LLC | Tbilisi | 0160 | Georgia |
| S. Khechinashvili University Hospital LLC | Tbilisi | 0179 | Georgia |
| Hospital Universitario Saltillo | Saltillo | Coahuila | 25000 | Mexico |
| Instituto Nacional de Neurologia y Neurocirugia | Mexico City | Delegacion Tlalpan | 14269 | Mexico |
| Centro Regional para Adulto Mayor, Hsp Univ, JEG | Monterrey | Nuevo León | 64460 | Mexico |
| Clinicos y Especialidades Medicas | Monterrey | Nuevo León | 64620 | Mexico |
| Christus Muguerza Hospital Sur | Monterrey | Nuevo León | 64988 | Mexico |
| Neurologi ZOZ Cntr Leczenia SM Badan Klinicznych | Plewiska | Poznan | 62-064 | Poland |
| MlynowaMed SP Psych Dr. Joanna Lazarcyck | Bialystok | 15-404 | Poland |
| Wlokiennicza Me Sp Prak Lekarska Dromasz Markowski | Bialystok | 15-464 | Poland |
| Przychodnia Srodmiescie Sp. z.o.o. | Bydgoszcz | 85-080 | Poland |
| ISPL Wieslaw Jerzy Cubala | Gdansk | 80-438 | Poland |
| NZOZ Wielospecjalistyczna Poradnia Lekarska Synap | Katowice | 40-123 | Poland |
| Silmedic Sp. z.o.o. | Katowice | 40-282 | Poland |
| Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3 | Krakow | 31-505 | Poland |
| Centrum Medyczne HCP Sp. z.o.o. | Poznan | 61-485 | Poland |
| NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz | Pruszcz Gdański | 83-000 | Poland |
| Neuro-Care Sp. z.o.o. sp. Komandytowa | Siemianowice Śląskie | 41-100 | Poland |
| Neuro-care | Siemianowice Śląskie | 41-100 | Poland |
| RCMed Oddzial Sochaczew, ul. _eromskiego 41A | Sochaczew | 96-500 | Poland |
| Spitalul Clinic Judetean de Urgenta Cluj-Napoca | Cluj-Napoca | Cluj | 400012 | Romania |
| Spitalul clinic CF Constanta, Sectia Neurologie | Constanța | 900123 | Romania |
| Med Anima SRL, Clinica de psihiatrie | Iași | 700004 | Romania |
| S.C. Carpe Diem SRL | Sibiu | 550281 | Romania |
| Regional Specialized Psychiatric Hospital #2 | Tonnel'nyy | Kochubeev District | 357034 | Russia |
| Federal Siberian Sci Clinical Center of Med and Bio | Krasnoyarsk | Krasnoyarksk Region | 660037 | Russia |
| Clinic "Hundred Years" | Tomsk | Tomsk Oblast | 634009 | Russia |
| Mental Health Research Center | Moscow | 115522 | Russia |
| City Clinical Hospital #34 | Novosibirsk | 630054 | Russia |
| Leningrad Regional Psychoneurological Dispensary | Roshchino | 188820 | Russia |
| St. Nicholas the Wonder Worker Psychiatric Hospital | Saint Petersburg | 190121 | Russia |
| FSBI NMRC PN n.a. V.M. Bekhterev | Saint Petersburg | 193167 | Russia |
| City Psychiatric Hospital #3 | Saint Petersburg | 197341 | Russia |
| Samara Psychiatric Hospital | Samara | 443016 | Russia |
| Saratov City Clinical Hospital V. I. Razumovsky | Saratov | 410028 | Russia |
| Smolensk State Medical University | Smolensk | 214019 | Russia |
| Stavropol Regional Clin Spec Psych Hospital #1 | Stavropol | 355038 | Russia |
| CHC Dr Dragisa Misovic- Dedinje | Belgrade | 11000 | Serbia |
| Clinical Center of Serbia, Clinic for Psychiatry | Belgrade | 11000 | Serbia |
| Military Medical Academy | Belgrade | 11000 | Serbia |
| Clinic for Psychiatric Diseases Dr. Laza Lazarevic | Belgrade | 18000 | Serbia |
| Klinicki Centar Srbije (KCS)- Klinika za nerurologiju | Belgrade | 34000 | Serbia |
| Special Hospital for Psychiatric Diseases "Kovin" | Kovin | 26220 | Serbia |
| Clinical Center Kragujevac, Clinic for Neurology | Kragujevac | 34000 | Serbia |
| Clinical Center Kragujevac, Clinic of Psychiatry | Kragujevac | 34000 | Serbia |
| Clinical Center Nis, Clinic for Psychiatry | Toponica | 18202 | Serbia |
| General Hospital Valjevo, Department for Neurology | Valjevo | 14000 | Serbia |
| Neurology Practice | Pretoria | Gauteng | 0014 | South Africa |
| Dr. Stanley Lipshitz Clinic Inc. | Sandton | Gauteng | 2146 | South Africa |
| Flexivest Fourteen Research Centre Potocnik F C V | Durbanville | Western Cape | 7500 | South Africa |
| Dnipr Regional Clinical Hospital n.a. Mechnikov | Dnipro | 49005 | Ukraine |
| I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital | Dnipro | 49005 | Ukraine |
| Dnipropetrovsk Regional Rehabilitation Hospital | Dnipro | 49128 | Ukraine |
| Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital | Ivano-Frankivsk | 76014 | Ukraine |
| Institute of Neruology, Nat Acad of Med Sci of UKR | Kharkiv | 61068 | Ukraine |
| Institute of Neurology | Kharkiv | 61068 | Ukraine |
| Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str | Kharkiv | 61068 | Ukraine |
| Kyiv Regional Medical Incorp. Psychiatria, Center | Kyiv | 04080 | Ukraine |
| Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str | Kyiv | 8630 | Ukraine |
| Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str. | Ternopil | 46027 | Ukraine |
| Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Male Department #7, Female Department #10, Vinnytsya, National Medical University n.a. M.I.Pyrogov, 109 Pyrogova str. | Vinnytsia | 21037 | Ukraine |
| Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology | Zaporizhzhya | 69600 | Ukraine |
| Zaporizhzhya Reg. Hospital, Neurology Dpt | Zaporizhzhya | 69600 | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All patients randomised
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Pimavanserin matching placebo (administered as 2 capsules) once daily |
| BG001 | Pimavanserin 34 mg | Pimavanserin 34 mg (administered as 2 x 17 mg capsules) once daily |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Treatment-emergent Adverse Events (TEAEs) | Number (%) of patients with treatment-emergent AEs | All patients randomised and treated | Posted | Count of Participants | Participants | Treatment Period: 8 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) | The ESRS is a questionnaire to assess drug induced movement disorders, including parkinsonism; the ESRS-A is an accepted modified form of the original ESRS. The ESRS-A consists of 4 subscales and 4 clinical global impression movement severity scales of Parkinsonism, dyskinesia, dystonia, and akathisia. The Parkinsonism scale consists of 10 items, the dyskinesia subscale of 6 items, the dystonia subscale of 6 items, and the akathisia subscale of 2 items. Each item is scored on a 6-point scale from 0 (absent) to 5 (extreme). The ESRS-A total score is the sum of the 24 item scores with a possible range of 0 to 120. Higher scores denote more severe drug-induced movement disorders. | All patients randomised and treated | Posted | Least Squares Mean | Standard Error | score on a scale | Treatment Period: 8 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE) | The MMSE is a 30-item questionnaire to quantitatively assess cognition, focusing on questions related to time and place of testing, repeating lists of words, arithmetic, language use and comprehension, and copying a drawing. Each of the 30 items has 2 possible values of 0 (incorrect) or 1 (correct). The MMSE total score is derived as the sum of the 30 item scores; thus, it can range from 0 to 30. Lower scores indicate more severe cognitive impairment. | All patients randomised and treated | Posted | Least Squares Mean | Standard Error | score on a scale | Treatment Period: 8 weeks |
|
|
Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
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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 | Pimavanserin matching placebo (administered as 2 capsules) once daily | 2 | 392 | 6 | 392 | 16 | 392 |
| EG001 | Pimavanserin 34 mg | Pimavanserin 34 mg (administered as 2 x 17 mg capsules) once daily | 2 | 392 | 8 | 392 | 25 | 392 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Femure fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
Investigator may publish the study results, relative to their 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. | 58-261 | 2897 | medicalinformation@acadia-pharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2022 | Nov 22, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| C510793 | pimavanserin |
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| Male |
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| Asian |
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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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| Romania |
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| United States |
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| Czechia |
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| Ukraine |
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| Poland |
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| Mexico |
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| South Africa |
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| Georgia |
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| Russia |
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| Bulgaria |
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| Serbia |
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| Participants |
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