Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Neuropsychiatric Symptoms Related to Neurodegenerative Disease Clinical Trial

Official title:

A 52-Week Open-label Extension Study of Pimavanserin in Adult and Elderly Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623321
• Other study ID #: ACP-103-047
• Secondary ID: 2017-004439-36
• Status: Completed
• Phase: Phase 3
• Start date: July 17, 2018
• Est. completion date: May 5, 2023

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 595
• Est. completion date: May 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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). -

Related Conditions & MeSH terms

• Neurodegenerative Diseases
• Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Intervention

Drug:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Colombia,  Czechia,  Georgia,  Mexico,  Poland,  Romania,  Russian Federation,  Serbia,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Treatment-emergent adverse events (TEAEs)		Treatment period and Follow-up period: 56 weeks