Clinical trial NCT03623321: Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Official title: A 52-Week Open-label Extension Study of Pimavanserin in Adult and Elderly Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-09
Enrollment: 595
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Subject satisfied all entry criteria for the antecedent pimavanserin study
2. Subject completed the antecedent study; or was participating in a pimavanserin study that the Sponsor ended early
3. Has a designated study partner/caregiver who meets the following requirements:

   1. 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
   2. 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
   3. Is fluent in the local language in which study assessments will be administered
   4. Agrees to participate in study assessments, has the capacity to provide informed consent, and provides written consent to participate in the study
4. Subject is willing and able to provide informed consent.
5. 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:

1. 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
2. Is in hospice, is receiving end-of-life palliative care, or has become bedridden
3. 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
4. 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.
5. Has clinically significant laboratory abnormalities in the antecedent study that, in the judgment of the Investigator or Medical Monitor, would either:

   1. jeopardize the safe participation of the subject in the study; OR
   2. would interfere with the conduct or interpretation of safety or efficacy evaluations in the study
6. Is suicidal at Visit 1 (Baseline)
7. 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
8. Requires treatment with a medication or other substance that is prohibited by the protocol
9. Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
10. 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).

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Primary outcomes:
measure: Treatment-emergent Adverse Events (TEAEs)
timeFrame: Treatment period and Follow-up period: 56 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Cognitive Clinical Trials
state: Arizona
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Hialeah
country: United States
facility: Indago Research & Health Center Inc
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Miami
country: United States
facility: Global Medical Institutes
state: Florida
city: Miami
country: United States
facility: Future Care Solution, LLC
state: Florida
city: Miami
country: United States
facility: MediClear Medical & Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Novel Clinical Research LLC
state: Florida
city: North Palm Beach
country: United States
facility: Laszlo J Mate, MD, PA
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc.
state: Florida
city: Mount Arlington
country: United States
facility: The NeuroCognitive Institute
state: New Jersey
city: Chapel Hill
country: United States
facility: UNC Hospital
state: North Carolina
city: Shaker Heights
country: United States
facility: Insight Clinical Trials LLC
state: Ohio
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Knoxville
country: United States
facility: Central for Biomedical Research, LLC
state: Tennessee
city: Bourgas
country: Bulgaria
facility: Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero
city: Pleven
country: Bulgaria
facility: UMHAT Psych clin for gen psychiatry and addictions
city: Sofia
country: Bulgaria
facility: DCC Sv. Vrach and Sv. Sv. Kozma and Damyan
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Centre, 2, N. Vaptzarov Street
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd.
city: Vratsa
country: Bulgaria
facility: Mental Health Center Vratza EOOD, 1 Belasitsa St.
city: Bello
country: Colombia
facility: E.S.E. Hospital Mental de Antioquia
state: Antioquia,
city: Barranquilla
country: Colombia
facility: Centr Investigaciones y Proyectos en Neurociencias
state: Atlántico
city: Pereira
country: Colombia
facility: Psynapsis Salud Mental S.A.
state: Risaralda
city: Bogotá
country: Colombia
facility: Centro de Investigaciones del Sistema Nervioso
city: Kladno
country: Czechia
facility: BRAIN-SOULTHERAPY s.r.o., Lekarna Jalta, Namesti Jana Masaryka 3113
city: Plzen
country: Czechia
facility: A-shine s.r.o./ Lekarna Centrum
city: Praha 5
country: Czechia
facility: Axon Clinical
city: Praha 6
country: Czechia
facility: Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1
city: Praha
country: Czechia
facility: AD71, s.r.o./Hostivarska lekarna
city: Tbilisi
country: Georgia
facility: Petre Sarajishvili Institute of Neurology LLC
city: Tbilisi
country: Georgia
facility: Pineo Medical Ecosystem LTD
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic LTD
city: Tbilisi
country: Georgia
facility: Health Institute LLC
city: Tbilisi
country: Georgia
facility: S. Khechinashvili University Hospital LLC
city: Saltillo
country: Mexico
facility: Hospital Universitario Saltillo
state: Coahuila
city: Monterrey
country: Mexico
facility: Clinicos y Especialidades Medicas
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Christus Muguerza Hospital Sur
state: Nuevo Leon
city: Białystok
country: Poland
facility: MlynowaMed Sp Psych Dr. Joanna Lazarczyk
city: Białystok
country: Poland
facility: Wlokienniecza Med Sp Prak Lekarska Dromasz Markowski
city: Bydgoszcz
country: Poland
facility: Przychodnia Srodmiescie Sp. z.o.o.
city: Gdańsk
country: Poland
facility: ISPL Wieslaw Jerzy Cubala
city: Gdańsk
country: Poland
facility: NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz
city: Kraków
country: Poland
facility: Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3
city: Poznań
country: Poland
facility: Centrum Medyczne HCP Sp. zo.o
city: Siemianowice Śląskie
country: Poland
facility: Neuro-Care Sp. zo.o. sp. Komandytowa
city: Siemianowice Śląskie
country: Poland
facility: Neuro-care
city: Sochaczew
country: Poland
facility: RCMed Oddzial Sochaczew, ul. _eromskiego 41A
city: Constanta
country: Romania
facility: Spitalul clinic CF Constanta, Sectia Neurologie
city: Iasi
country: Romania
facility: Med Anima SRL, Clinica de psihiatrie
city: Sibiu
country: Romania
facility: S.C. Carpe Diem SRL
city: Tonnel'nyy
country: Russian Federation
facility: Regional Specialized Psychiatric Hospital #2
state: Kochubeev District
city: Krasnoyarsk
country: Russian Federation
facility: Federal Siberian Sci Clinical Center of Med and Bio
city: Moscow
country: Russian Federation
facility: Mental Health Research Center
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital #34
city: Roshchino
country: Russian Federation
facility: Leningrad Regional Psychoneurological Dispensary
city: Saint Petersburg
country: Russian Federation
facility: St. Nicholas the Wonder Worker Psychiatric Hospital
city: Saint Petersburg
country: Russian Federation
facility: FSBI NMRC PN n.a. V.M. Bekhterev
city: Samara
country: Russian Federation
facility: Samara Psychiatric Hospital
city: Saratov
country: Russian Federation
facility: Saratov City Clinical Hospital V. I. Razumovsky
city: Stavropol'
country: Russian Federation
facility: Stavropol Regional Clin Spec Psych Hospital #1
city: Tomsk
country: Russian Federation
facility: Clinic "Hundred Years"
city: Belgrade
country: Serbia
facility: CHC Dr Dragisa Misovic- Dedinje
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Clinic for Psychiatry
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia,Clinic for Neurology
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinic for Psychiatric Diseases Dr. Laza Lazarevic
city: Belgrade
country: Serbia
facility: Klinicki Centar Srbije (KCS)- Klinika za nerurologiju
city: Kovin
country: Serbia
facility: Special Hospital for Psychiatric Diseases "Kovin"
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac, Clinic for Neurology
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac,Clinic of Psychiatry
city: Toponica
country: Serbia
facility: Clinical Center Nis, Clinic for Psychiatry
city: Valjevo
country: Serbia
facility: General Hospital Valjevo, Department for Neurology
city: Pretoria
country: South Africa
facility: Neurology Practice
state: Gauteng
city: Durban
country: South Africa
facility: Flexivest Fourteen Research Centre Potocnik F C V
state: Western Cape
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk Regional Rehabilitation Hospital
city: Dnipro
country: Ukraine
facility: Dnir. Regional Clinical Hospital n.a. Mechnikov
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital
city: Kharkiv
country: Ukraine
facility: Institute of Neruology, Nat Acad of Med Sci of UKR
city: Kharkiv
country: Ukraine
facility: Institute of Neurology
city: Kharkiv
country: Ukraine
facility: Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str.
city: Kyiv
country: Ukraine
facility: Kyiv Regional Medical Incorp. Psychiatria, Center
city: Kyiv
country: Ukraine
facility: Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str., Glevakha
city: Ternopil'
country: Ukraine
facility: Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.
city: Vinnytsia
country: Ukraine
facility: 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
city: Zaporizhzhya
country: Ukraine
facility: Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology
Study officials:
References: