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

NCT ID: NCT03623321

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 595 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2023-05-05

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.

Conditions

Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pimavanserin

Intervention Type: DRUG

• 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.

Interventions

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.

Intervention Type: DRUG

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

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• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ACADIA Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cognitive Clinical Trials

Gilbert, Arizona, United States

ATP Clinical Research, Inc.

Costa Mesa, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

Indago Research & Health Center Inc

Hialeah, Florida, United States

Reliable Clinical Research, LLC

Hialeah, Florida, 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

Laszlo J Mate, MD, PA

North Palm Beach, Florida, United States

Synexus Clinical Research US, Inc.

The Villages, Florida, United States

The NeuroCognitive Institute

Mount Arlington, New Jersey, United States

UNC Hospital

Chapel Hill, North Carolina, United States

Insight Clinical Trials LLC

Shaker Heights, Ohio, United States

Suburban Research Associates

Media, Pennsylvania, United States

Central for Biomedical Research, LLC

Knoxville, Tennessee, United States

Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero

Burgas, , 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, , 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 Department, Colombia

Centro de Investigaciones del Sistema Nervioso

Bogotá, , Colombia

BRAIN-SOULTHERAPY s.r.o., Lekarna Jalta, Namesti Jana Masaryka 3113

Kladno, , Czechia

A-shine s.r.o./ Lekarna Centrum

Pilsen, , Czechia

AD71, s.r.o./Hostivarska lekarna

Prague, , Czechia

Axon Clinical

Prague, , Czechia

Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1

Prague, , Czechia

Petre Sarajishvili Institute of Neurology LLC

Tbilisi, , Georgia

Pineo Medical Ecosystem LTD

Tbilisi, , Georgia

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

Clinicos y Especialidades Medicas

Monterrey, Nuevo León, Mexico

Christus Muguerza Hospital Sur

Monterrey, Nuevo León, Mexico

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

Krakow, , Poland

Centrum Medyczne HCP Sp. zo.o

Poznan, , Poland

Neuro-Care Sp. zo.o. sp. Komandytowa

Siemianowice Śląskie, , Poland

Neuro-care

Siemianowice Śląskie, , Poland

RCMed Oddzial Sochaczew, ul. _eromskiego 41A

Sochaczew, , Poland

Spitalul clinic CF Constanta, Sectia Neurologie

Constanța, , Romania

Med Anima SRL, Clinica de psihiatrie

Iași, , Romania

S.C. Carpe Diem SRL

Sibiu, , Romania

Regional Specialized Psychiatric Hospital #2

Tonnel'nyy, Kochubeev District, Russia

Federal Siberian Sci Clinical Center of Med and Bio

Krasnoyarsk, , Russia

Mental Health Research Center

Moscow, , Russia

City Clinical Hospital #34

Novosibirsk, , Russia

Leningrad Regional Psychoneurological Dispensary

Roshchino, , Russia

St. Nicholas the Wonder Worker Psychiatric Hospital

Saint Petersburg, , Russia

FSBI NMRC PN n.a. V.M. Bekhterev

Saint Petersburg, , Russia

Samara Psychiatric Hospital

Samara, , Russia

Saratov City Clinical Hospital V. I. Razumovsky

Saratov, , Russia

Stavropol Regional Clin Spec Psych Hospital #1

Stavropol, , Russia

Clinic "Hundred Years"

Tomsk, , Russia

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

Military Medical Academy

Belgrade, , Serbia

Clinic for Psychiatric Diseases Dr. Laza Lazarevic

Belgrade, , Serbia

Klinicki Centar Srbije (KCS)- Klinika za nerurologiju

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, , Serbia

Neurology Practice

Pretoria, Gauteng, South Africa

Flexivest Fourteen Research Centre Potocnik F C V

Durban, Western Cape, South Africa

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-Frankivsk, , 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, , Ukraine

Countries

United States; Bulgaria; Colombia; Czechia; Georgia; Mexico; Poland; Romania; Russia; Serbia; South Africa; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-004439-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACP-103-047

Identifier Type: -

Identifier Source: org_study_id