Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

Schizophrenia Clinical Trial

Official title:

A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03121586
• Other study ID #: ACP-103-035
• Secondary ID: 2016-003435-38
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: ACADIA Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 996
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Pimavanserin
Pimavanserin 10 mg, tablet, taken as one 10 mg tablets, once daily by mouth, OR Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  Croatia,  Czechia,  Hungary,  Italy,  Lithuania,  Poland,  Russian Federation,  Serbia,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability])	Evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia	52 weeks