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

Phase 3

Completed

• Conditions: Neuropsychiatric Symptoms Related to Neurodegenerative Disease
• Interventions: Drug: Pimavanserin

• Registration Number: NCT03623321
• Lead Sponsor: ACADIA Pharmaceuticals Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-17
• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-09
• Primary Completion: 2023-05-05
• Study Completion: 2023-05-05
• Results First Submitted: 2024-11-20
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Results First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 595

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug - pimavanserin	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.

Primary Outcome Measures

Name	Time	Method
Treatment-emergent Adverse Events (TEAEs)	Treatment period and Follow-up period: 56 weeks	Number (%) of patients experiencing at least one TEAE

Trial Locations

Locations (88)

A-shine s.r.o./ Lekarna Centrum; 🇨🇿 Plzen, Czechia

Regional Specialized Psychiatric Hospital #2; 🇷🇺 Tonnel'nyy, Kochubeev District, Russian Federation

Federal Siberian Sci Clinical Center of Med and Bio; 🇷🇺 Krasnoyarsk, Russian Federation

Synexus Clinical Research US, Inc.; 🇺🇸 The Villages, Florida, United States

Pineo Medical Ecosystem LTD; 🇬🇪 Tbilisi, Georgia

NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz; 🇵🇱 Gdańsk, Poland

Clinicos y Especialidades Medicas; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Christus Muguerza Hospital Sur; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Mental Health Research Center; 🇷🇺 Moscow, Russian Federation

Samara Psychiatric Hospital; 🇷🇺 Samara, Russian Federation

Saratov City Clinical Hospital V. I. Razumovsky; 🇷🇺 Saratov, Russian Federation

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

Special Hospital for Psychiatric Diseases "Kovin"; 🇷🇸 Kovin, 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

Flexivest Fourteen Research Centre Potocnik F C V; 🇿🇦 Durban, Western Cape, South Africa

Dnipropetrovsk Regional Rehabilitation Hospital; 🇺🇦 Dnipro, Ukraine

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

Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str., Glevakha; 🇺🇦 Kyiv, Ukraine

Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.; 🇺🇦 Ternopil', Ukraine

Kyiv Regional Medical Incorp. Psychiatria, Center; 🇺🇦 Kyiv, 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

Cognitive Clinical Trials; 🇺🇸 Gilbert, Arizona, United States

Syrentis Clinical Research; 🇺🇸 Santa Ana, California, United States

Reliable Clinical Research, LLC; 🇺🇸 Hialeah, Florida, United States

Indago Research & Health Center Inc; 🇺🇸 Hialeah, Florida, United States

Laszlo J Mate, MD, PA; 🇺🇸 North Palm Beach, Florida, United States

The NeuroCognitive Institute; 🇺🇸 Mount Arlington, New Jersey, United States

Insight Clinical Trials LLC; 🇺🇸 Shaker Heights, Ohio, United States

Suburban Research Associates; 🇺🇸 Media, Pennsylvania, United States

UMHAT Psych clin for gen psychiatry and addictions; 🇧🇬 Pleven, Bulgaria

Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero; 🇧🇬 Bourgas, Bulgaria

DCC Sv. Vrach and Sv. Sv. Kozma and Damyan; 🇧🇬 Sofia, Bulgaria

Mental Health Center Vratza EOOD, 1 Belasitsa St.; 🇧🇬 Vratsa, Bulgaria

Diagnostic Consultative Centre, 2, N. Vaptzarov Street; 🇧🇬 Varna, Bulgaria

Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd.; 🇧🇬 Varna, 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, Colombia

Centro de Investigaciones del Sistema Nervioso; 🇨🇴 Bogotá, Colombia

BRAIN-SOULTHERAPY s.r.o., Lekarna Jalta, Namesti Jana Masaryka 3113; 🇨🇿 Kladno, Czechia

Axon Clinical; 🇨🇿 Praha 5, Czechia

AD71, s.r.o./Hostivarska lekarna; 🇨🇿 Praha, Czechia

Petre Sarajishvili Institute of Neurology LLC; 🇬🇪 Tbilisi, Georgia

Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1; 🇨🇿 Praha 6, Czechia

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

MlynowaMed Sp Psych Dr. Joanna Lazarczyk; 🇵🇱 Białystok, Poland

Wlokienniecza Med Sp Prak Lekarska Dromasz Markowski; 🇵🇱 Białystok, Poland

Przychodnia Srodmiescie Sp. z.o.o.; 🇵🇱 Bydgoszcz, Poland

ISPL Wieslaw Jerzy Cubala; 🇵🇱 Gdańsk, Poland

Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3; 🇵🇱 Kraków, Poland

Centrum Medyczne HCP Sp. zo.o; 🇵🇱 Poznań, Poland

Neuro-care; 🇵🇱 Siemianowice Śląskie, Poland

Neuro-Care Sp. zo.o. sp. Komandytowa; 🇵🇱 Siemianowice Śląskie, Poland

RCMed Oddzial Sochaczew, ul. _eromskiego 41A; 🇵🇱 Sochaczew, Poland

Spitalul clinic CF Constanta, Sectia Neurologie; 🇷🇴 Constanta, Romania

Med Anima SRL, Clinica de psihiatrie; 🇷🇴 Iasi, Romania

S.C. Carpe Diem SRL; 🇷🇴 Sibiu, Romania

Leningrad Regional Psychoneurological Dispensary; 🇷🇺 Roshchino, Russian Federation

St. Nicholas the Wonder Worker Psychiatric Hospital; 🇷🇺 Saint Petersburg, Russian Federation

City Clinical Hospital #34; 🇷🇺 Novosibirsk, Russian Federation

FSBI NMRC PN n.a. V.M. Bekhterev; 🇷🇺 Saint Petersburg, Russian Federation

Stavropol Regional Clin Spec Psych Hospital #1; 🇷🇺 Stavropol', Russian Federation

Clinic "Hundred Years"; 🇷🇺 Tomsk, Russian Federation

Military Medical Academy; 🇷🇸 Belgrade, Serbia

Clinic for Psychiatric Diseases Dr. Laza Lazarevic; 🇷🇸 Belgrade, Serbia

Klinicki Centar Srbije (KCS)- Klinika za nerurologiju; 🇷🇸 Belgrade, Serbia

Clinical Center Kragujevac, Clinic for Neurology; 🇷🇸 Kragujevac, Serbia

Neurology Practice; 🇿🇦 Pretoria, Gauteng, South Africa

Central for Biomedical Research, LLC; 🇺🇸 Knoxville, Tennessee, United States

ATP Clinical Research, Inc.; 🇺🇸 Costa Mesa, California, 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

UNC Hospital; 🇺🇸 Chapel Hill, North Carolina, United States