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

NCT03623321 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: ACP-103-0472017-004439-36
• Study Type: interventional
• Target: 595
• Locations: 12 countries
• Sites: 88

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

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent Adverse Events (TEAEs)

  Number (%) of patients experiencing at least one TEAE

  Treatment period and Follow-up period: 56 weeks

Study Arms (1)

Drug - pimavanserin

EXPERIMENTAL

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.

Drug: Pimavanserin

Interventions

Pimavanserin 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.

Drug - pimavanserin

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject satisfied all entry criteria for the antecedent pimavanserin study
• Subject completed the antecedent study; or was participating in a pimavanserin study that the Sponsor ended early
• Has a designated study partner/caregiver who meets the following requirements:
• 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
• 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
• Is fluent in the local language in which study assessments will be administered
• Agrees to participate in study assessments, has the capacity to provide informed consent, and provides written consent to participate in the study
• Subject is willing and able to provide informed consent.
• 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.

You may not qualify if:

• 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
• Is in hospice, is receiving end-of-life palliative care, or has become bedridden
• 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
• 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.
• Has clinically significant laboratory abnormalities in the antecedent study that, in the judgment of the Investigator or Medical Monitor, would either:
• jeopardize the safe participation of the subject in the study; OR
• would interfere with the conduct or interpretation of safety or efficacy evaluations in the study
• Is suicidal at Visit 1 (Baseline)
• 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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (88)

Cognitive Clinical Trials

Gilbert, Arizona, 85296, United States

Location

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Indago Research & Health Center Inc

Hialeah, Florida, 33012, United States

Location

Reliable Clinical Research, LLC

Hialeah, Florida, 33012, United States

Location

Premier Clinical Research Institute, Inc.

Miami, Florida, 33122, United States

Location

Global Medical Institutes

Miami, Florida, 33125, United States

Location

Future Care Solution, LLC

Miami, Florida, 33165, United States

Location

MediClear Medical & Research Center, Inc.

Miami, Florida, 33165, United States

Location

Novel Clinical Research LLC

Miami, Florida, 33186, United States

Location

Laszlo J Mate, MD, PA

North Palm Beach, Florida, 33408, United States

Location

Synexus Clinical Research US, Inc.

The Villages, Florida, 32162, United States

Location

The NeuroCognitive Institute

Mount Arlington, New Jersey, 07856, United States

Location

UNC Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Insight Clinical Trials LLC

Shaker Heights, Ohio, 44122, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Central for Biomedical Research, LLC

Knoxville, Tennessee, 37909, United States

Location

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

Burgas, 8000, Bulgaria

Location

UMHAT Psych clin for gen psychiatry and addictions

Pleven, 5800, Bulgaria

Location

DCC Sv. Vrach and Sv. Sv. Kozma and Damyan

Sofia, 1408, Bulgaria

Location

Diagnostic Consultative Centre, 2, N. Vaptzarov Street

Varna, 9000, Bulgaria

Location

Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd.

Varna, 9000, Bulgaria

Location

Mental Health Center Vratza EOOD, 1 Belasitsa St.

Vratsa, 3000, Bulgaria

Location

E.S.E. Hospital Mental de Antioquia

Bello, Antioquia, 051053, Colombia

Location

Centr Investigaciones y Proyectos en Neurociencias

Barranquilla, Atlántico, 080020, Colombia

Location

Psynapsis Salud Mental S.A.

Pereira, Risaralda Department, 66001, Colombia

Location

Centro de Investigaciones del Sistema Nervioso

Bogotá, 111166, Colombia

Location

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

Kladno, 27204, Czechia

Location

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

Pilsen, 31200, Czechia

Location

AD71, s.r.o./Hostivarska lekarna

Prague, 10200, Czechia

Location

Axon Clinical

Prague, 1500, Czechia

Location

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

Prague, 16010, Czechia

Location

Petre Sarajishvili Institute of Neurology LLC

Tbilisi, 0112, Georgia

Location

Pineo Medical Ecosystem LTD

Tbilisi, 0114, Georgia

Location

Tbilisi Heart and Vascular Clinic LTD

Tbilisi, 0159, Georgia

Location

Health Institute LLC

Tbilisi, 0160, Georgia

Location

S. Khechinashvili University Hospital LLC

Tbilisi, 0179, Georgia

Location

Hospital Universitario Saltillo

Saltillo, Coahuila, 25000, Mexico

Location

Clinicos y Especialidades Medicas

Monterrey, Nuevo León, 64620, Mexico

Location

Christus Muguerza Hospital Sur

Monterrey, Nuevo León, 64988, Mexico

Location

MlynowaMed Sp Psych Dr. Joanna Lazarczyk

Bialystok, 15-404, Poland

Location

Wlokienniecza Med Sp Prak Lekarska Dromasz Markowski

Bialystok, 15-464, Poland

Location

Przychodnia Srodmiescie Sp. z.o.o.

Bydgoszcz, 85-080, Poland

Location

ISPL Wieslaw Jerzy Cubala

Gdansk, 80-438, Poland

Location

NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz

Gdansk, 83-000, Poland

Location

Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3

Krakow, 31-505, Poland

Location

Centrum Medyczne HCP Sp. zo.o

Poznan, 61-485, Poland

Location

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

Siemianowice Śląskie, 41-100, Poland

Location

Neuro-care

Siemianowice Śląskie, 41-100, Poland

Location

RCMed Oddzial Sochaczew, ul. _eromskiego 41A

Sochaczew, 96-500, Poland

Location

Spitalul clinic CF Constanta, Sectia Neurologie

Constanța, 900123, Romania

Location

Med Anima SRL, Clinica de psihiatrie

Iași, 700004, Romania

Location

S.C. Carpe Diem SRL

Sibiu, 550281, Romania

Location

Regional Specialized Psychiatric Hospital #2

Tonnel’nyy, Kochubeev District, 357034, Russia

Location

Federal Siberian Sci Clinical Center of Med and Bio

Krasnoyarsk, 660037, Russia

Location

Mental Health Research Center

Moscow, 115522, Russia

Location

City Clinical Hospital #34

Novosibirsk, 630054, Russia

Location

Leningrad Regional Psychoneurological Dispensary

Roshchino, 188820, Russia

Location

St. Nicholas the Wonder Worker Psychiatric Hospital

Saint Petersburg, 190121, Russia

Location

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

Saint Petersburg, 1931167, Russia

Location

Samara Psychiatric Hospital

Samara, 443016, Russia

Location

Saratov City Clinical Hospital V. I. Razumovsky

Saratov, 410028, Russia

Location

Stavropol Regional Clin Spec Psych Hospital #1

Stavropol, 355038, Russia

Location

Clinic "Hundred Years"

Tomsk, 634009, Russia

Location

CHC Dr Dragisa Misovic- Dedinje

Belgrade, 11000, Serbia

Location

Clinical Center of Serbia, Clinic for Psychiatry

Belgrade, 11000, Serbia

Location

Clinical Center of Serbia,Clinic for Neurology

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Clinic for Psychiatric Diseases Dr. Laza Lazarevic

Belgrade, 18000, Serbia

Location

Klinicki Centar Srbije (KCS)- Klinika za nerurologiju

Belgrade, 34000, Serbia

Location

Special Hospital for Psychiatric Diseases "Kovin"

Kovin, 26220, Serbia

Location

Clinical Center Kragujevac, Clinic for Neurology

Kragujevac, 34000, Serbia

Location

Clinical Center Kragujevac,Clinic of Psychiatry

Kragujevac, 34000, Serbia

Location

Clinical Center Nis, Clinic for Psychiatry

Toponica, 18202, Serbia

Location

General Hospital Valjevo, Department for Neurology

Valjevo, 14000, Serbia

Location

Neurology Practice

Pretoria, Gauteng, 0014, South Africa

Location

Flexivest Fourteen Research Centre Potocnik F C V

Durban, Western Cape, 7500, South Africa

Location

Dnipropetrovsk Regional Rehabilitation Hospital

Dnipro, 49000, Ukraine

Location

Dnir. Regional Clinical Hospital n.a. Mechnikov

Dnipro, 49005, Ukraine

Location

Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital

Ivano-Frankivsk, 76014, Ukraine

Location

Institute of Neruology, Nat Acad of Med Sci of UKR

Kharkiv, 61068, Ukraine

Location

Institute of Neurology

Kharkiv, 61068, Ukraine

Location

Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str.

Kharkiv, 61068, Ukraine

Location

Kyiv Regional Medical Incorp. Psychiatria, Center

Kyiv, 04080, Ukraine

Location

Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str., Glevakha

Kyiv, 8630, Ukraine

Location

Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.

Ternopil, 46027, Ukraine

Location

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, 21037, Ukraine

Location

Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology

Zaporizhzhya, 69600, Ukraine

Location

MeSH Terms

Interventions

pimavanserin

Results Point of Contact

• Title: Sr. Dir. Medical Information and Medical Communications
• Organization: Acadia Pharmaceuticals Inc.

medicalinformation@acadia-pharm.com

858-261

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 9, 2018
• Study Start: July 17, 2018
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

UA (11); RO (3); BU (6); CO (4); CZ (5); RU (11); GE (5); US (17); ZA (2); PL (10); SE (11); ME (3)