Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004439-36 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the long-term safety and tolerability of pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease exposed to open-label pimavanserin for up to 52 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug - pimavanserin | Experimental | Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimavanserin | Drug | • Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events (TEAEs) | Number (%) of patients experiencing at least one TEAE | Treatment period and Follow-up period: 56 weeks |
Not provided
Not provided
Inclusion Criteria:
Subject satisfied all entry criteria for the antecedent pimavanserin study
Subject completed the antecedent study; or was participating in a pimavanserin study that the Sponsor ended early
Has a designated study partner/caregiver who meets the following requirements:
Subject is willing and able to provide informed consent.
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 during the study and 1 month following completion of the study.
Exclusion Criteria:
Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study, due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study, or is judged to be a danger to self or others
Is in hospice, is receiving end-of-life palliative care, or has become bedridden
Has any of the following ECG results at the EOT/ET visit of the antecedent study:
a. If the subject is not on citalopram, escitalopram, or venlafaxine:
i. QTcF >450 ms, if QRS duration <120 ms
ii. QTcF >470 ms, if QRS duration ≥120 ms
b. If the subject is on citalopram, escitalopram, or venlafaxine:
i. QTcF >425 ms, if QRS duration <120 ms
ii. QTcF >450 ms, if QRS duration ≥120 ms
Has a heart rate <50 beats per minute. If bradycardia is secondary to iatrogenic or treatable causes and these causes are treated, a heart rate assessment can be repeated at the EOT/ET visit of the antecedent study.
Has clinically significant laboratory abnormalities in the antecedent study that, in the judgment of the Investigator or Medical Monitor, would either:
Is suicidal at Visit 1 (Baseline)
Has developed a medical condition that in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
Requires treatment with a medication or other substance that is prohibited by the protocol
Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
Is an employee of ACADIA, or has a family member who is an employee of ACADIA
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).
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognitive Clinical Trials | Gilbert | Arizona | 85296 | United States | ||
| ATP Clinical Research, Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This was an open-label extension study to evaluate the long-term safety and tolerability of pimavanserin in patients with neuropsychiatric symptoms related to neurodegenerative disease, who had completed an antecedent study (ACP-103-046) or had participated in a pimavanserin study that the sponsor terminated early.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pimavanserin | Pimavanserin 34 mg once daily (QD). Dose reductions to pimavanserin 20 mg and subsequent dose increases to 34 mg were allowed at any time, based on investigator assessment of clinical response of the patient. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 20, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 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 |
| Synexus Clinical Research US, Inc. | The Villages | Florida | 32162 | 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 | 051053 | 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 |
| A-shine s.r.o./ Lekarna Centrum | Pilsen | 31200 | Czechia |
| AD71, s.r.o./Hostivarska lekarna | Prague | 10200 | Czechia |
| Axon Clinical | Prague | 1500 | Czechia |
| Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1 | Prague | 16010 | 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 |
| Clinicos y Especialidades Medicas | Monterrey | Nuevo León | 64620 | Mexico |
| Christus Muguerza Hospital Sur | Monterrey | Nuevo León | 64988 | Mexico |
| MlynowaMed Sp Psych Dr. Joanna Lazarczyk | Bialystok | 15-404 | Poland |
| Wlokienniecza Med 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 Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz | Gdansk | 83-000 | Poland |
| Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3 | Krakow | 31-505 | Poland |
| Centrum Medyczne HCP Sp. zo.o | Poznan | 61-485 | Poland |
| Neuro-Care Sp. zo.o. sp. Komandytowa | Siemianowice ÅšlÄ…skie | 41-100 | Poland |
| Neuro-care | Siemianowice ÅšlÄ…skie | 41-100 | Poland |
| RCMed Oddzial Sochaczew, ul. _eromskiego 41A | Sochaczew | 96-500 | Poland |
| 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 | 660037 | 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 | 1931167 | Russia |
| Samara Psychiatric Hospital | Samara | 443016 | Russia |
| Saratov City Clinical Hospital V. I. Razumovsky | Saratov | 410028 | Russia |
| Stavropol Regional Clin Spec Psych Hospital #1 | Stavropol | 355038 | Russia |
| Clinic "Hundred Years" | Tomsk | 634009 | Russia |
| CHC Dr Dragisa Misovic- Dedinje | Belgrade | 11000 | Serbia |
| Clinical Center of Serbia, Clinic for Psychiatry | Belgrade | 11000 | Serbia |
| Clinical Center of Serbia,Clinic for Neurology | 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 |
| Flexivest Fourteen Research Centre Potocnik F C V | Durban | Western Cape | 7500 | South Africa |
| Dnipropetrovsk Regional Rehabilitation Hospital | Dnipro | 49000 | Ukraine |
| Dnir. Regional Clinical Hospital n.a. Mechnikov | Dnipro | 49005 | 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., Glevakha | 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, Department of Psychiatry, Narcology and Psychotherapeutics | Vinnytsia | 21037 | Ukraine |
| Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology | Zaporizhzhya | 69600 | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All patients enrolled and treated
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pimavanserin | Pimavanserin 34 mg once daily (QD). Dose reductions to pimavanserin 20 mg and subsequent dose increases to 34 mg were allowed at any time, based on investigator assessment of clinical response of the patient. |
| 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 |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Mini Mental State Examination total score | The MMSE is a 30-item questionnaire to assess cognitive impairment. It focuses on areas of time and place of testing, repeating lists of words, arithmetic, language use and comprehension, and copying or drawing. Each of the 30 items has 2 possible values i.e. 0 (incorrect) or 1 (correct). The MMSE total score is derived as the sum of the item scores; it has a potential range of 0 to 30, with lower scores indicating greater cognitive impairment. | Mean | Standard Deviation | units on a scale |
|
| 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 experiencing at least one TEAE | Posted | Count of Participants | Participants | Treatment period and Follow-up period: 56 weeks |
|
|
|
Treatment period and Follow-up period: 56 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pimavanserin | Pimavanserin 34 mg once daily (QD). Dose reductions to pimavanserin 20 mg and subsequent dose increases to 34 mg were allowed at any time, based on investigator assessment of clinical response of the patient. | 11 | 595 | 37 | 595 | 0 | 595 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Not provided
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. | 858-261 | 2897 | medicalinformation@acadia-pharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2021 | Nov 20, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C510793 | pimavanserin |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Czechia |
|
| Ukraine |
|
| Poland |
|
| Mexico |
|
| South Africa |
|
| Georgia |
|
| Bulgaria |
|
| Serbia |
|
| Russia |
|