Clinical trial NCT03121586: Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Official title: A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-20
Enrollment: 996
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia


Eligibility criteria: Inclusion Criteria:

1. Patient is able to understand and provide signed informed consent
2. Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures and who is also able to provide input helpful for completing study rating scale
3. Is completing the Week 6 visit in Study ACP-103-034 or the Week 26 visit in Study ACP-103-038 or 064 while continuing to take his/her assigned dose of blinded study drug and may, in the Investigator's opinion, benefit from continued adjunctive treatment with pimavanserin to a antipsychotic
4. 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 two clinically acceptable methods of contraception
5. The main background antipsychotic with which the subject is being treated must continue to be on one of the antipsychotics listed below:

   * Aripiprazole
   * Aripiprazole long-acting injectables:

     * Abilify Maintena®
     * Aristada®
   * Asenapine
   * Risperidone
   * Risperidone long-acting injection
   * Olanzapine
   * Paliperidone extended release (ER) (≤9 mg)
   * Paliperidone palmitate

     * Invega Sustenna® (≤156 mg)
     * Invega Trinza® (≤546 mg)
     * Trevicta® (≤350 mg)
     * Xeplion® (≤100 mg)
   * Lurasidone
   * Cariprazine
   * Brexpiprazole
   * Asenapine

Exclusion Criteria:

1. Patient is judged by the Investigator or the Medical Monitor to be inappropriate for the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -064)
2. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse

   1. Subjects from Studies 034 and 038 with a result indicating the presence of marijuana are permitted, if allowed by medical regulations, if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
   2. Subjects from Study 064 with a result indicating the presence of marijuana are not permitted in the study
3. Is taking a medication or drug or other substance that is prohibited according to this protocol
4. Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval
5. Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study.

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).

Primary outcomes:
measure: Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability])
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 171-Alea Research Institute
state: Arizona
city: Little Rock
country: United States
facility: 156-Woodland International Research Group, LLC
state: Arkansas
city: Rogers
country: United States
facility: 111-Woodland Research Northwest, LLC
state: Arkansas
city: Bellflower
country: United States
facility: 167-CITrials - Bellflower
state: California
city: Culver City
country: United States
facility: 105-ProScience Research Group
state: California
city: Lemon Grove
country: United States
facility: 123-Synergy San Diego
state: California
city: San Diego
country: United States
facility: 164-Artemis Institute for Clinical Research
state: California
city: Santa Ana
country: United States
facility: 165-CITrials
state: California
city: Torrance
country: United States
facility: 108-Collaborative Nueroscience Network, LLC
state: California
city: Hialeah
country: United States
facility: 125-Galiz Research
state: Florida
city: Lauderhill
country: United States
facility: 137-Innovative Clinical Research, Inc.
state: Florida
city: Miami
country: United States
facility: 146-Premier Clinical Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: 162-Synexus Clinical Research, Inc.
state: Georgia
city: Atlanta
country: United States
facility: 168-Atlanta Center for Medical Research
state: Georgia
city: Marietta
country: United States
facility: 102-Northwest Behavioral Research Center
state: Georgia
city: Chicago
country: United States
facility: 114-Northwestern University
state: Illinois
city: Chicago
country: United States
facility: 101-American Medical Research
state: Illinois
city: Hoffman Estates
country: United States
facility: 130-Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Lake Charles
country: United States
facility: 118-Lake Charles Clinical Trials
state: Louisiana
city: Las Vegas
country: United States
facility: 124-Altea Research Institute
state: Nevada
city: Berlin
country: United States
facility: 141-Hassman Research Institute
state: New Jersey
city: Albuquerque
country: United States
facility: 153-Albuquerque Neuroscience Inc.
state: New Mexico
city: Cedarhurst
country: United States
facility: 104-Neurobehavioral Research, Inc.
state: New York
city: Jamaica
country: United States
facility: 140-Synexus Clinical Research, Inc - 140
state: New York
city: Rochester
country: United States
facility: 128-Finger Lakes Clinical Research
state: New York
city: Charlotte
country: United States
facility: 106-New Hope Clinical Research
state: North Carolina
city: Durham
country: United States
facility: 145-Carolina Behavioral Care
state: North Carolina
city: Oklahoma City
country: United States
facility: 110-Cutting Edge Research Group
state: Oklahoma
city: Downingtown
country: United States
facility: 170-Suburban Research Associates
state: Pennsylvania
city: Irving
country: United States
facility: 127-University Hills Clinical Research
state: Texas
city: Richardson
country: United States
facility: 103-Pillar Clinical Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: 115-Psychiatric and Behavioral Solutions LLC
state: Utah
city: Buenos Aires
country: Argentina
facility: 610-Clinica Privada Banfield S.A.
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: 603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEM
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: 625-NOVAIN Neurociencias Group
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: 601-CENydET- Centro Neurobiologico y de Estres Traumatico-Biopsychomedical Research Group SRL
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: 602-FunDamoS
city: Ciudad de Mendoza
country: Argentina
facility: 607-Resolution Psicopharmacology Research Institute
city: Cordoba
country: Argentina
facility: 626-Sanatorio Prof. Leon S. Morra S.A.
city: Córdoba
country: Argentina
facility: 622-Instituto Medico Damic Srl
city: Córdoba
country: Argentina
facility: 624-Centro Especializado en Neurociencias CEN
city: La Plata
country: Argentina
facility: 617-INSA Instituto de Neurociencias San Agustin S.A.
city: La Plata
country: Argentina
facility: 623-Clinica Privada de Salud Mental Santa Teresa de Avila
city: Burgas
country: Bulgaria
facility: 454-Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD
city: Kardzhali
country: Bulgaria
facility: 533-State Psychiatric Hospital - Kardzhali, EOOD
city: Kazanlak
country: Bulgaria
facility: 532-MHAT "Dr. Hristo Stambolski", EOOD
city: Lovech
country: Bulgaria
facility: 569-State Psychiatric Hospital - Lovech
city: Pazardzhik
country: Bulgaria
facility: 406-State Psychiatric Hospital - Pazardzhik AD
city: Pleven
country: Bulgaria
facility: 535-UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: 586-Medical Center Mentalcare OOD
city: Plovdiv
country: Bulgaria
facility: 563-MC-Hipokrat-N E00D
city: Plovdiv
country: Bulgaria
facility: 403-University Multiprofile hospital for activated treatment Sveti Georgi, Clinic of psychiatry
city: Plovdiv
country: Bulgaria
facility: 592-Medical center Spectar - Plovdiv EOOD
city: Sofia
country: Bulgaria
facility: 570-Medical Centre "Sveti Naum"
city: Sofia
country: Bulgaria
facility: 497-MHC - Sofia, EOOD
city: Sofia
country: Bulgaria
facility: 526-DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
city: Sofia
country: Bulgaria
facility: 402-Military Medical Academy, Multiprofile Hospital for Actie Treatment - Sofia
city: Sofia
country: Bulgaria
facility: 405-UMHAT "Alexandrovska" EAD
city: Sofia
country: Bulgaria
facility: 568-Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: 528-Medical Center Intermedica, OOD
city: Targovishte
country: Bulgaria
facility: 404-MHAT-Targovishte, AD
city: Tsarev Brod
country: Bulgaria
facility: 590-State Psychiatric Hospital - Tzarev Brod
city: Varna
country: Bulgaria
facility: 498-DCC "Mladost M" - Varna, OOD
city: Veliko Tarnovo
country: Bulgaria
facility: 455-Mental Health Center - Veliko Tarnovo EOOD
city: Vratsa
country: Bulgaria
facility: 401-Mental Health Center-Vratsa EOOD
city: Chatham
country: Canada
facility: Chatham-Kent Clinical Trials Research Ctr
state: Ontario
city: Montréal
country: Canada
facility: 351-McGill University Health Ctr Allan Memorial Int.
state: Quebec
city: Chatham
country: Canada
facility: 356-Chatham-Kent Clinical Trials Research Ctr
city: Zagreb
country: Croatia
facility: 536 - Clinic for psychiatry Vrapce
city: Zagreb
country: Croatia
facility: 537 - Clinic for psychiatry Vrapce
city: Zagreb
country: Croatia
facility: 550-Clinic for psychiatry Vrapce
city: Zagreb
country: Croatia
facility: 557 - Clinic for psychiatry Vrapce
city: Zagreb
country: Croatia
facility: 594-Klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika
city: Hradec Králové
country: Czechia
facility: 512-NeuropsychiatrieHK s.r.o.
city: Klecany
country: Czechia
facility: 583-Narodni ustav dusevniho zdravi
city: Plzen
country: Czechia
facility: 519-A-SHINE s.r.o.
city: Praha 10
country: Czechia
facility: 513-CLINTRIAL s.r.o.
city: Praha 10
country: Czechia
facility: 499-MUDr. Tibor Miklos
city: Říčany
country: Czechia
facility: 511-Psychiatrie Ricany s.r.o.
city: Kalocsa
country: Hungary
facility: 410-Dr. Máthé és Társa Bt.
state: Bács-Kiskun Megye
city: Budapest
country: Hungary
facility: 411-ÓBudai Egészségűgyi Centrum Kft
state: Pest Megye
city: Budapest
country: Hungary
facility: 456-Semmelweis University Department of Psychiatry and Psychotherapy
state: Pest Megye
city: Budapest
country: Hungary
facility: 520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
city: Pécs
country: Hungary
facility: 440-PsychoTech Kft.
city: Milano
country: Italy
facility: 566-Ospedale San Raffaele (San Raffaele Turro)
city: Torino
country: Italy
facility: 553-AO Città della Salute e della Scienza di Torino
city: Kaunas
country: Lithuania
facility: 483-Romuvos klinika, UAB
city: Kaunas
country: Lithuania
facility: 518-Kaunas City Outpatient Clinic, Public Institution
city: Silute
country: Lithuania
facility: 484-Medical Center Puriena JSC
city: Vilnius
country: Lithuania
facility: 517-Zirmunai Mental Health Center, Public Institution
city: Białystok
country: Poland
facility: 525-Podlaskie Centrum Psychogeriatrii
city: Bydgoszcz
country: Poland
facility: 502-Przychodnia Srodmiescie Sp. z o. o.
city: Gdańsk
country: Poland
facility: 579-Centrum Badan Klinicznych P.I. House Sp. z o.o.
city: Lublin
country: Poland
facility: 501-Specjalistyczna Praktyka Lekarska Marek Domański
city: Pruszków
country: Poland
facility: 578-MSCZ im. Prof. J. Mazurkiewicza
city: Plekhanovo
country: Russian Federation
facility: 505-GUZ Lipetsk Regional psychoneurological Hospital #1
state: Lipetsk Region
city: Tonnel'nyy
country: Russian Federation
facility: 417-State Budget Healthcare Institution of Stavropol Region (Regional Specialized Psychiatric Hospital #2)
state: Stavropol Region
city: Arkhangel'sk
country: Russian Federation
facility: 418-State Budget Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Psychiatric Hospital"
city: Leningrad
country: Russian Federation
facility: 419-State municipal healthcare Institution "Leningrad region psychoneurological center"
city: Moscow
country: Russian Federation
facility: 459-Federal State Budgetary Research Institution "Mental Health Science Center"
city: Moscow
country: Russian Federation
facility: 573-SBIH of Moscow "Psychiatric Clinical Hospital # 4 n.a. P.B. Gannushkin" Short name: PCH N4 n.a. P.B.Gannushkin
city: Moscow
country: Russian Federation
facility: 581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"
city: Saint Petersburg
country: Russian Federation
facility: 415-Saint-Petersburg State Healthcare Institution "Saint Nicolas Wonderworker Psychiatric Hospital"
city: Saint Petersburg
country: Russian Federation
facility: 451-V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology
city: Saint Petersburg
country: Russian Federation
facility: 453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
city: Saint Petersburg
country: Russian Federation
facility: 465-"Saint-Petersburg Scientific Research Psychoneurological Institute N.A. V.M. Bekhterev"
city: Saint Petersburg
country: Russian Federation
facility: 495-FSBI "National Medical Scientifi Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH
city: Saint Petersburg
country: Russian Federation
facility: 443-Saint-Petersburg State Budget Healthcare Institution "Psychoneurological Center #5"
city: Saint Petersburg
country: Russian Federation
facility: 444-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov"
city: Saint Petersburg
country: Russian Federation
facility: 452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a.I.I. Skvortsov-Stepanov
city: Saint Petersburg
country: Russian Federation
facility: 496-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov
city: Saint Petersburg
country: Russian Federation
facility: 458-State Budget Healthcare Institution "Samara Psychiatric Hospital"
city: Saint-Petersburg
country: Russian Federation
facility: 571-St. Petersburg SHI "Psychoneurological Dispensary #10"
city: Saint-Petersburg
country: Russian Federation
facility: 464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)"
city: Smolensk
country: Russian Federation
facility: 416-FSBEI HE "Smolensk State Medical University" of the MoH of the RF
city: Stavropol'
country: Russian Federation
facility: 420-"Podderzhka" Research and Educational Center of Psychotherapy Limited Liability Company
city: Tomsk
country: Russian Federation
facility: 572-Klinika StoLet" Ltd.
city: Voronezh
country: Russian Federation
facility: 466-OOO "Lion-Med"
city: Yaroslavl
country: Russian Federation
facility: 422-State Budget Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Psychiatric Hospital"
city: Belgrade
country: Serbia
facility: 428-Clinical center of Serbia
city: Belgrade
country: Serbia
facility: 425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry
city: Belgrade
country: Serbia
facility: 471-Clinic for Psychiatric Diseases "Dr Laza Lazarevic"
city: Belgrade
country: Serbia
facility: 524-General Hospital Euromedik
city: Belgrad
country: Serbia
facility: 424-Institute of Mental health
city: Belgrad
country: Serbia
facility: 587-Institute of Mental Health
city: Belgrad
country: Serbia
facility: 584-Clinic for Psychiatry, Clinical Canter of Serbia
city: Kovin
country: Serbia
facility: 472-Special Hospital for Psychiatric Diseases "Kovin"
city: Kovin
country: Serbia
facility: 493-Special Neuropsychiatric Hospital Kovin
city: Kragujevac
country: Serbia
facility: 423-Clinical Center Kragujevac
city: Kragujevac
country: Serbia
facility: 429-Clinical Center Kragujevac, Clinic of Psychiatry
city: Kragujevac
country: Serbia
facility: 430-Psychiatric Clinic, Clinical Center Kragujevac
city: Nis
country: Serbia
facility: 427-Clinical Center Nis, Clinic of Mental Health
city: Niš
country: Serbia
facility: 585-Special Hospital for Psychiatric Diseases "Gornja Toponica"
city: Novi Kneževac
country: Serbia
facility: 593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"
city: Barcelona
country: Spain
facility: 476-FIDMAG Germanes Hospitalaries
city: Barcelona
country: Spain
facility: 574-Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: 588-Institucion Hospitalaria Hestia Palau - Ensayos clinicos
city: Madrid
country: Spain
facility: 475-Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: 575-Hospital Universitario 12 de Octubre
city: Oviedo
country: Spain
facility: 494-CSM La Corredoria
city: Valladolid
country: Spain
facility: 431-Centro de Salud Parquesol, 2ª planta - Servicio de Psiquiatria
city: Zamora
country: Spain
facility: 529-Hospital Provincial de Zamora
city: Odessa
country: Ukraine
facility: 438-Communal Establishment "Odesa Regional Psychiatric Hospital #2"
state: Oblast
city: Dnipro
country: Ukraine
facility: 462-Communal Establishment "I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital"
city: Hlevakha
country: Ukraine
facility: 510-CI of Kyiv RC Regional Psychiatric-Narcological Medical Association, Depart #10 (male), Dept #2 (female)
city: Kharkiv
country: Ukraine
facility: 433-SI "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine"
city: Kharkiv
country: Ukraine
facility: 434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology
city: Kharkiv
country: Ukraine
facility: 582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU
city: Kharkiv
country: Ukraine
facility: 567-CIH Kharkiv Regional Clinical Psychiatric Hospital #3 Psychiatric Department of Primary Psychotic Episod Short Site name: CIH KRCPH #3 PD of PPE
city: Kherson
country: Ukraine
facility: 461-Kherson Regional Psychiatric Hospital
city: Kyiv
country: Ukraine
facility: 507-Main Military Clinical Hospital of MDU
city: Kyiv
country: Ukraine
facility: 447-Ukrainian Scientific Research Institute of Social and Forensic Psychiatry and Narcology of Ministry of Healthcare of Ukraine
city: Kyiv
country: Ukraine
facility: Kyiv Regional Medical Incorporation Psychiatry Center of Novel Treatment and Rehabilitation of Psychotic Disorders, Department #29, Department #30
city: Kyiv
country: Ukraine
facility: 460-Kyiv City Psychoneurological Hospital #3, General Psychiatry Department No. 2
city: Kyiv
country: Ukraine
facility: 435-Kyiv Regional Medical Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders, build 5, Department #30
city: Nove
country: Ukraine
facility: 564-Regional Clinical Psychiatric Hospital
city: Odesa
country: Ukraine
facility: 509-CI Odesa Regional Medical Centre of Mental Health
city: Smila
country: Ukraine
facility: 508-CI Cherkasy Regional Psychiatric Hospital of ChRC Female Dept #11, Male Dept #12
city: Vinnytsia
country: Ukraine
facility: Communal Establishment "Acad. O.I. Iushchenko Vinnytsia Regional Psychoneurologic Hospital"
city: Vinnytsia
country: Ukraine
facility: 432-Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko", Male Department No 14, Female Department No 15, Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept of Psychiatry, Narcology and Psychothera
city: Úzhgorod
country: Ukraine
facility: 591-Municipal non-profit enterprise "Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions" of the Transcarpathian Regional Council, Department of psychiatry
Study officials:
References: