Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
- Conditions
- Neuropsychiatric Symptoms Related to Neurodegenerative Disease
- Interventions
- Registration Number
- NCT03623321
- Lead Sponsor
- ACADIA Pharmaceuticals Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 595
-
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:
- In the Investigator's opinion, is in contact with the subject frequently enough to accurately report on the subject's symptoms and whether or not the subject is taking the study drug
- In the Investigator's opinion, is considered reliable in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures
- Is fluent in the local language in which study assessments will be administered
- Agrees to participate in study assessments, has the capacity to provide informed consent, and provides written consent to participate in the study
-
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.
-
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:
- jeopardize the safe participation of the subject in the study; OR
- would interfere with the conduct or interpretation of safety or efficacy evaluations in the study
-
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Drug - pimavanserin Pimavanserin 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.
- Primary Outcome Measures
Name Time Method Treatment-emergent Adverse Events (TEAEs) Treatment period and Follow-up period: 56 weeks Number (%) of patients experiencing at least one TEAE
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (88)
A-shine s.r.o./ Lekarna Centrum
🇨🇿Plzen, Czechia
Regional Specialized Psychiatric Hospital #2
🇷🇺Tonnel'nyy, Kochubeev District, Russian Federation
Federal Siberian Sci Clinical Center of Med and Bio
🇷🇺Krasnoyarsk, Russian Federation
Synexus Clinical Research US, Inc.
🇺🇸The Villages, Florida, United States
Pineo Medical Ecosystem LTD
🇬🇪Tbilisi, Georgia
NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz
🇵🇱Gdańsk, Poland
Clinicos y Especialidades Medicas
🇲🇽Monterrey, Nuevo Leon, Mexico
Christus Muguerza Hospital Sur
🇲🇽Monterrey, Nuevo Leon, Mexico
Mental Health Research Center
🇷🇺Moscow, Russian Federation
Samara Psychiatric Hospital
🇷🇺Samara, Russian Federation
Saratov City Clinical Hospital V. I. Razumovsky
🇷🇺Saratov, Russian Federation
CHC Dr Dragisa Misovic- Dedinje
🇷🇸Belgrade, Serbia
Clinical Center of Serbia, Clinic for Psychiatry
🇷🇸Belgrade, Serbia
Clinical Center of Serbia,Clinic for Neurology
🇷🇸Belgrade, Serbia
Special Hospital for Psychiatric Diseases "Kovin"
🇷🇸Kovin, Serbia
Clinical Center Kragujevac,Clinic of Psychiatry
🇷🇸Kragujevac, Serbia
Clinical Center Nis, Clinic for Psychiatry
🇷🇸Toponica, Serbia
General Hospital Valjevo, Department for Neurology
🇷🇸Valjevo, Serbia
Flexivest Fourteen Research Centre Potocnik F C V
🇿🇦Durban, Western Cape, South Africa
Dnipropetrovsk Regional Rehabilitation Hospital
🇺🇦Dnipro, Ukraine
Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str.
🇺🇦Kharkiv, Ukraine
Dnir. Regional Clinical Hospital n.a. Mechnikov
🇺🇦Dnipro, Ukraine
Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital
🇺🇦Ivano-Frankivs'k, Ukraine
Institute of Neruology, Nat Acad of Med Sci of UKR
🇺🇦Kharkiv, Ukraine
Institute of Neurology
🇺🇦Kharkiv, Ukraine
Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str., Glevakha
🇺🇦Kyiv, Ukraine
Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.
🇺🇦Ternopil', Ukraine
Kyiv Regional Medical Incorp. Psychiatria, Center
🇺🇦Kyiv, 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, Ukraine
Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology
🇺🇦Zaporizhzhya, Ukraine
Cognitive Clinical Trials
🇺🇸Gilbert, Arizona, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Reliable Clinical Research, LLC
🇺🇸Hialeah, Florida, United States
Indago Research & Health Center Inc
🇺🇸Hialeah, Florida, United States
Laszlo J Mate, MD, PA
🇺🇸North Palm Beach, Florida, United States
The NeuroCognitive Institute
🇺🇸Mount Arlington, New Jersey, United States
Insight Clinical Trials LLC
🇺🇸Shaker Heights, Ohio, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
UMHAT Psych clin for gen psychiatry and addictions
🇧🇬Pleven, Bulgaria
Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero
🇧🇬Bourgas, Bulgaria
DCC Sv. Vrach and Sv. Sv. Kozma and Damyan
🇧🇬Sofia, Bulgaria
Mental Health Center Vratza EOOD, 1 Belasitsa St.
🇧🇬Vratsa, Bulgaria
Diagnostic Consultative Centre, 2, N. Vaptzarov Street
🇧🇬Varna, Bulgaria
Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd.
🇧🇬Varna, Bulgaria
E.S.E. Hospital Mental de Antioquia
🇨🇴Bello, Antioquia,, Colombia
Centr Investigaciones y Proyectos en Neurociencias
🇨🇴Barranquilla, Atlántico, Colombia
Psynapsis Salud Mental S.A.
🇨🇴Pereira, Risaralda, Colombia
Centro de Investigaciones del Sistema Nervioso
🇨🇴Bogotá, Colombia
BRAIN-SOULTHERAPY s.r.o., Lekarna Jalta, Namesti Jana Masaryka 3113
🇨🇿Kladno, Czechia
Axon Clinical
🇨🇿Praha 5, Czechia
AD71, s.r.o./Hostivarska lekarna
🇨🇿Praha, Czechia
Petre Sarajishvili Institute of Neurology LLC
🇬🇪Tbilisi, Georgia
Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1
🇨🇿Praha 6, Czechia
Tbilisi Heart and Vascular Clinic LTD
🇬🇪Tbilisi, Georgia
Health Institute LLC
🇬🇪Tbilisi, Georgia
S. Khechinashvili University Hospital LLC
🇬🇪Tbilisi, Georgia
Hospital Universitario Saltillo
🇲🇽Saltillo, Coahuila, Mexico
MlynowaMed Sp Psych Dr. Joanna Lazarczyk
🇵🇱Białystok, Poland
Wlokienniecza Med Sp Prak Lekarska Dromasz Markowski
🇵🇱Białystok, Poland
Przychodnia Srodmiescie Sp. z.o.o.
🇵🇱Bydgoszcz, Poland
ISPL Wieslaw Jerzy Cubala
🇵🇱Gdańsk, Poland
Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3
🇵🇱Kraków, Poland
Centrum Medyczne HCP Sp. zo.o
🇵🇱Poznań, Poland
Neuro-care
🇵🇱Siemianowice Śląskie, Poland
Neuro-Care Sp. zo.o. sp. Komandytowa
🇵🇱Siemianowice Śląskie, Poland
RCMed Oddzial Sochaczew, ul. _eromskiego 41A
🇵🇱Sochaczew, Poland
Spitalul clinic CF Constanta, Sectia Neurologie
🇷🇴Constanta, Romania
Med Anima SRL, Clinica de psihiatrie
🇷🇴Iasi, Romania
S.C. Carpe Diem SRL
🇷🇴Sibiu, Romania
Leningrad Regional Psychoneurological Dispensary
🇷🇺Roshchino, Russian Federation
St. Nicholas the Wonder Worker Psychiatric Hospital
🇷🇺Saint Petersburg, Russian Federation
City Clinical Hospital #34
🇷🇺Novosibirsk, Russian Federation
FSBI NMRC PN n.a. V.M. Bekhterev
🇷🇺Saint Petersburg, Russian Federation
Stavropol Regional Clin Spec Psych Hospital #1
🇷🇺Stavropol', Russian Federation
Clinic "Hundred Years"
🇷🇺Tomsk, Russian Federation
Military Medical Academy
🇷🇸Belgrade, Serbia
Clinic for Psychiatric Diseases Dr. Laza Lazarevic
🇷🇸Belgrade, Serbia
Klinicki Centar Srbije (KCS)- Klinika za nerurologiju
🇷🇸Belgrade, Serbia
Clinical Center Kragujevac, Clinic for Neurology
🇷🇸Kragujevac, Serbia
Neurology Practice
🇿🇦Pretoria, Gauteng, South Africa
Central for Biomedical Research, LLC
🇺🇸Knoxville, Tennessee, United States
ATP Clinical Research, Inc.
🇺🇸Costa Mesa, California, United States
Premier Clinical Research Institute, Inc.
🇺🇸Miami, Florida, United States
Global Medical Institutes
🇺🇸Miami, Florida, United States
Future Care Solution, LLC
🇺🇸Miami, Florida, United States
MediClear Medical & Research Center, Inc.
🇺🇸Miami, Florida, United States
Novel Clinical Research LLC
🇺🇸Miami, Florida, United States
UNC Hospital
🇺🇸Chapel Hill, North Carolina, United States