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

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

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.

Study Overview

• Status: Completed
• Conditions: Neuropsychiatric Symptoms Related to Neurodegenerative Disease
• Intervention / Treatment: Drug: Pimavanserin

• Study Type: Interventional
• Enrollment (Actual): 595
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Bourgas, Bulgaria, 8000
    • Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero
  • Pleven, Bulgaria, 5800
    • UMHAT Psych clin for gen psychiatry and addictions
  • Sofia, Bulgaria, 1408
    • DCC Sv. Vrach and Sv. Sv. Kozma and Damyan
  • Varna, Bulgaria, 9000
    • Diagnostic Consultative Centre, 2, N. Vaptzarov Street
  • Varna, Bulgaria, 9000
    • Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd.
  • Vratsa, Bulgaria, 3000
    • Mental Health Center Vratza EOOD, 1 Belasitsa St.
• Colombia
  • Bogotá, Colombia, 111166
    • Centro de Investigaciones del Sistema Nervioso
  • Antioquia,
    • Bello, Antioquia,, Colombia, 051053
      • E.S.E. Hospital Mental de Antioquia
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 080020
      • Centr Investigaciones y Proyectos en Neurociencias
  • Risaralda
    • Pereira, Risaralda, Colombia, 66001
      • Psynapsis Salud Mental S.A.
• Czechia
  • Kladno, Czechia, 27204
    • BRAIN-SOULTHERAPY s.r.o., Lekarna Jalta, Namesti Jana Masaryka 3113
  • Plzen, Czechia, 31200
    • A-shine s.r.o./ Lekarna Centrum
  • Praha, Czechia, 10200
    • AD71, s.r.o./Hostivarska lekarna
  • Praha 5, Czechia, 1500
    • AXON Clinical
  • Praha 6, Czechia, 16010
    • Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1
• Georgia
  • Tbilisi, Georgia, 0114
    • Pineo Medical Ecosystem LTD
  • Tbilisi, Georgia, 0160
    • Health Institute LLC
  • Tbilisi, Georgia, 0112
    • Petre Sarajishvili Institute of Neurology LLC
  • Tbilisi, Georgia, 0159
    • Tbilisi Heart and Vascular Clinic Ltd
  • Tbilisi, Georgia, 0179
    • S. Khechinashvili University Hospital LLC
• Mexico
  • Coahuila
    • Saltillo, Coahuila, Mexico, 25000
      • Hospital Universitario Saltillo
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64620
      • Clinicos y Especialidades Medicas
    • Monterrey, Nuevo Leon, Mexico, 64988
      • Christus Muguerza Hospital Sur
• Poland
  • Białystok, Poland, 15-404
    • MlynowaMed Sp Psych Dr. Joanna Lazarczyk
  • Białystok, Poland, 15-464
    • Wlokienniecza Med Sp Prak Lekarska Dromasz Markowski
  • Bydgoszcz, Poland, 85-080
    • Przychodnia Srodmiescie Sp. z.o.o.
  • Gdańsk, Poland, 80-438
    • ISPL Wieslaw Jerzy Cubala
  • Gdańsk, Poland, 83-000
    • NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz
  • Kraków, Poland, 31-505
    • Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3
  • Poznań, Poland, 61-485
    • Centrum Medyczne HCP Sp. zo.o
  • Siemianowice Śląskie, Poland, 41-100
    • Neuro-Care
  • Siemianowice Śląskie, Poland, 41-100
    • Neuro-Care Sp. zo.o. sp. Komandytowa
  • Sochaczew, Poland, 96-500
    • RCMed Oddzial Sochaczew, ul. _eromskiego 41A
• Romania
  • Constanta, Romania, 900123
    • Spitalul clinic CF Constanta, Sectia Neurologie
  • Iasi, Romania, 700004
    • Med Anima SRL, Clinica de psihiatrie
  • Sibiu, Romania, 550281
    • S.C. Carpe Diem SRL
• Russian Federation
  • Krasnoyarsk, Russian Federation, 660037
    • Federal Siberian Sci Clinical Center of Med and Bio
  • Moscow, Russian Federation, 115522
    • Mental Health Research Center
  • Novosibirsk, Russian Federation, 630054
    • City Clinical Hospital #34
  • Roshchino, Russian Federation, 188820
    • Leningrad Regional Psychoneurological Dispensary
  • Saint Petersburg, Russian Federation, 190121
    • St. Nicholas the Wonder Worker Psychiatric Hospital
  • Saint Petersburg, Russian Federation, 1931167
    • FSBI NMRC PN n.a. V.M. Bekhterev
  • Samara, Russian Federation, 443016
    • Samara Psychiatric Hospital
  • Saratov, Russian Federation, 410028
    • Saratov City Clinical Hospital V. I. Razumovsky
  • Stavropol', Russian Federation, 355038
    • Stavropol Regional Clin Spec Psych Hospital #1
  • Tomsk, Russian Federation, 634009
    • Clinic "Hundred Years"
  • Kochubeev District
    • Tonnel'nyy, Kochubeev District, Russian Federation, 357034
      • Regional Specialized Psychiatric Hospital #2
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia, Clinic for Psychiatry
  • Belgrade, Serbia, 11000
    • CHC Dr Dragisa Misovic- Dedinje
  • Belgrade, Serbia, 18000
    • Clinic for Psychiatric Diseases Dr. Laza Lazarevic
  • Belgrade, Serbia, 34000
    • Klinicki Centar Srbije (KCS)- Klinika za nerurologiju
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia,Clinic for Neurology
  • Kovin, Serbia, 26220
    • Special Hospital for Psychiatric Diseases "Kovin"
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac, Clinic for Neurology
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac,Clinic of Psychiatry
  • Toponica, Serbia, 18202
    • Clinical Center Nis, Clinic for Psychiatry
  • Valjevo, Serbia, 14000
    • General Hospital Valjevo, Department for Neurology
• South Africa
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0014
      • Neurology Practice
  • Western Cape
    • Durban, Western Cape, South Africa, 7500
      • Flexivest Fourteen Research Centre Potocnik F C V
• Ukraine
  • Dnipro, Ukraine, 49000
    • Dnipropetrovsk Regional Rehabilitation Hospital
  • Dnipro, Ukraine, 49005
    • Dnir. Regional Clinical Hospital n.a. Mechnikov
  • Ivano-Frankivs'k, Ukraine, 76014
    • Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital
  • Kharkiv, Ukraine, 61068
    • Institute of Neruology, Nat Acad of Med Sci of UKR
  • Kharkiv, Ukraine, 61068
    • Institute of Neurology
  • Kharkiv, Ukraine, 61068
    • Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str.
  • Kyiv, Ukraine, 04080
    • Kyiv Regional Medical Incorp. Psychiatria, Center
  • Kyiv, Ukraine, 8630
    • Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str., Glevakha
  • Ternopil', Ukraine, 46027
    • Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.
  • Vinnytsia, Ukraine, 21037
    • 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
  • Zaporizhzhya, Ukraine, 69600
    • Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85296
      • Cognitive Clinical Trials
  • California
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research, Inc.
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
  • Florida
    • Hialeah, Florida, United States, 33012
      • Reliable Clinical Research, LLC
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center Inc
    • Miami, Florida, United States, 33165
      • Future Care Solution, LLC
    • Miami, Florida, United States, 33122
      • Premier Clinical Research Institute, Inc.
    • Miami, Florida, United States, 33125
      • Global Medical Institutes
    • Miami, Florida, United States, 33165
      • MediClear Medical & Research Center, Inc.
    • Miami, Florida, United States, 33186
      • Novel Clinical Research LLC
    • North Palm Beach, Florida, United States, 33408
      • Laszlo J Mate, MD, PA
    • The Villages, Florida, United States, 32162
      • Synexus Clinical Research US, Inc.
  • New Jersey
    • Mount Arlington, New Jersey, United States, 07856
      • The NeuroCognitive Institute
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Hospital
  • Ohio
    • Shaker Heights, Ohio, United States, 44122
      • Insight Clinical Trials LLC
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Central for Biomedical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• Treatment-emergent adverse events (TEAEs)	Treatment period and Follow-up period: 56 weeks

Collaborators and Investigators

• Sponsor: ACADIA Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurodegenerative Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Antiparkinson Agents; Anti-Dyskinesia Agents; Pimavanserin
• Other Study ID Numbers: ACP-103-047; 2017-004439-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No