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Neuropsychiatric Symptoms Related to Neurodegenerative DiseasePhase 3NCT03623321

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

A Phase 3 study testing Pimavanserin in people with Neuropsychiatric Symptoms Related to Neurodegenerative Disease, run by ACADIA Pharmaceuticals Inc. at 88 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Pimavanserin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
595 participants
Where
88 sitesin 12 countries
Study dates
17 Jul 2018to 5 May 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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:
  • If the subject is not on citalopram, escitalopram, or venlafaxine:
  • QTcF >450 ms, if QRS duration <120 ms
  • QTcF >470 ms, if QRS duration ≥120 ms
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  • If the subject is on citalopram, escitalopram, or venlafaxine:
  • QTcF >425 ms, if QRS duration <120 ms
  • 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
  • Requires treatment with a medication or other substance that is prohibited by the protocol
  • Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
  • 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).
  • -

Trial locations and contacts

88 sites in 12 countries.

88 sites in 12 countries

United States17 sites

  • UNC Hospital

    Chapel Hill, North Carolina, 27599

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Cognitive Clinical Trials

    Gilbert, Arizona, 85296

  • Indago Research & Health Center Inc

    Hialeah, Florida, 33012

  • Reliable Clinical Research, LLC

    Hialeah, Florida, 33012

  • Central for Biomedical Research, LLC

    Knoxville, Tennessee, 37909

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Premier Clinical Research Institute, Inc.

    Miami, Florida, 33122

  • Global Medical Institutes

    Miami, Florida, 33125

  • Future Care Solution, LLC

    Miami, Florida, 33165

  • MediClear Medical & Research Center, Inc.

    Miami, Florida, 33165

  • Novel Clinical Research LLC

    Miami, Florida, 33186

  • The NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • Laszlo J Mate, MD, PA

    North Palm Beach, Florida, 33408

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Insight Clinical Trials LLC

    Shaker Heights, Ohio, 44122

  • Synexus Clinical Research US, Inc.

    The Villages, Florida, 32162

Other trials in United States

Russia11 sites

  • Federal Siberian Sci Clinical Center of Med and Bio

    Krasnoyarsk, 660037

  • Mental Health Research Center

    Moscow, 115522

  • City Clinical Hospital #34

    Novosibirsk, 630054

  • Leningrad Regional Psychoneurological Dispensary

    Roshchino, 188820

  • St. Nicholas the Wonder Worker Psychiatric Hospital

    Saint Petersburg, 190121

  • FSBI NMRC PN n.a. V.M. Bekhterev

    Saint Petersburg, 1931167

  • Samara Psychiatric Hospital

    Samara, 443016

  • Saratov City Clinical Hospital V. I. Razumovsky

    Saratov, 410028

  • Stavropol Regional Clin Spec Psych Hospital #1

    Stavropol, 355038

  • Clinic "Hundred Years"

    Tomsk, 634009

  • Regional Specialized Psychiatric Hospital #2

    Tonnel'nyy, Kochubeev District, 357034

Other trials in Russia

Serbia11 sites

  • CHC Dr Dragisa Misovic- Dedinje

    Belgrade, 11000

  • Clinical Center of Serbia, Clinic for Psychiatry

    Belgrade, 11000

  • Clinical Center of Serbia,Clinic for Neurology

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinic for Psychiatric Diseases Dr. Laza Lazarevic

    Belgrade, 18000

  • Klinicki Centar Srbije (KCS)- Klinika za nerurologiju

    Belgrade, 34000

  • Special Hospital for Psychiatric Diseases "Kovin"

    Kovin, 26220

  • Clinical Center Kragujevac, Clinic for Neurology

    Kragujevac, 34000

  • Clinical Center Kragujevac,Clinic of Psychiatry

    Kragujevac, 34000

  • Clinical Center Nis, Clinic for Psychiatry

    Toponica, 18202

  • General Hospital Valjevo, Department for Neurology

    Valjevo, 14000

Other trials in Serbia

Ukraine11 sites

  • Dnipropetrovsk Regional Rehabilitation Hospital

    Dnipro, 49000

  • Dnir. Regional Clinical Hospital n.a. Mechnikov

    Dnipro, 49005

  • Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital

    Ivano-Frankivsk, 76014

  • Institute of Neruology, Nat Acad of Med Sci of UKR

    Kharkiv, 61068

  • Institute of Neurology

    Kharkiv, 61068

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

    Kharkiv, 61068

  • Kyiv Regional Medical Incorp. Psychiatria, Center

    Kyiv, 04080

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

    Kyiv, 8630

  • Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.

    Ternopil, 46027

  • 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

  • Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology

    Zaporizhzhya, 69600

Other trials in Ukraine

Poland10 sites

  • MlynowaMed Sp Psych Dr. Joanna Lazarczyk

    Bialystok, 15-404

  • Wlokienniecza Med Sp Prak Lekarska Dromasz Markowski

    Bialystok, 15-464

  • Przychodnia Srodmiescie Sp. z.o.o.

    Bydgoszcz, 85-080

  • ISPL Wieslaw Jerzy Cubala

    Gdansk, 80-438

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

    Gdansk, 83-000

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

    Krakow, 31-505

  • Centrum Medyczne HCP Sp. zo.o

    Poznan, 61-485

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

    Siemianowice Śląskie, 41-100

  • Neuro-care

    Siemianowice Śląskie, 41-100

  • RCMed Oddzial Sochaczew, ul. _eromskiego 41A

    Sochaczew, 96-500

Other trials in Poland

Bulgaria6 sites

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

    Burgas, 8000

  • UMHAT Psych clin for gen psychiatry and addictions

    Pleven, 5800

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

    Sofia, 1408

  • Diagnostic Consultative Centre, 2, N. Vaptzarov Street

    Varna, 9000

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

    Varna, 9000

  • Mental Health Center Vratza EOOD, 1 Belasitsa St.

    Vratsa, 3000

Other trials in Bulgaria

Czechia5 sites

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

    Kladno, 27204

  • A-shine s.r.o./ Lekarna Centrum

    Pilsen, 31200

  • AD71, s.r.o./Hostivarska lekarna

    Prague, 10200

  • Axon Clinical

    Prague, 1500

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

    Prague, 16010

Other trials in Czechia

Georgia5 sites

  • Petre Sarajishvili Institute of Neurology LLC

    Tbilisi, 0112

  • Pineo Medical Ecosystem LTD

    Tbilisi, 0114

  • Tbilisi Heart and Vascular Clinic LTD

    Tbilisi, 0159

  • Health Institute LLC

    Tbilisi, 0160

  • S. Khechinashvili University Hospital LLC

    Tbilisi, 0179

Other trials in Georgia

Colombia4 sites

  • Centr Investigaciones y Proyectos en Neurociencias

    Barranquilla, Atlántico, 080020

  • E.S.E. Hospital Mental de Antioquia

    Bello, Antioquia, 051053

  • Centro de Investigaciones del Sistema Nervioso

    Bogotá, 111166

  • Psynapsis Salud Mental S.A.

    Pereira, Risaralda Department, 66001

Other trials in Colombia

Mexico3 sites

  • Clinicos y Especialidades Medicas

    Monterrey, Nuevo León, 64620

  • Christus Muguerza Hospital Sur

    Monterrey, Nuevo León, 64988

  • Hospital Universitario Saltillo

    Saltillo, Coahuila, 25000

Other trials in Mexico

Romania3 sites

  • Spitalul clinic CF Constanta, Sectia Neurologie

    Constanța, 900123

  • Med Anima SRL, Clinica de psihiatrie

    Iași, 700004

  • S.C. Carpe Diem SRL

    Sibiu, 550281

Other trials in Romania

South Africa2 sites

  • Flexivest Fourteen Research Centre Potocnik F C V

    Durban, Western Cape, 7500

  • Neurology Practice

    Pretoria, Gauteng, 0014

Other trials in South Africa

About this study

Official title: 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.

Being tested
Pimavanserin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PimavanserinDrug

    • 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.
Study groups in NCT03623321
Study groupRoleWhat they receive
Drug - pimavanserinExperimentalPimavanserin 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.
Receives: Drug: Pimavanserin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-emergent Adverse Events (TEAEs)

    Number (%) of patients experiencing at least one TEAE

    Measured: Treatment period and Follow-up period: 56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2018
  2. Study start17 Jul 2018
  3. Primary completion5 May 2023
  4. Study completion5 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
595 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03623321
Sponsor's protocol ID
ACP-103-047
Other IDs
2017-004439-36, 2017
Status last verified
Dec 2024
First submitted
7 Aug 2018
Last updated
20 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pimavanserin in people with Neuropsychiatric Symptoms Related to Neurodegenerative Disease, run by ACADIA Pharmaceuticals Inc. at 88 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Russia, Serbia, Ukraine, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-emergent Adverse Events (TEAEs) (time frame: Treatment period and Follow-up period: 56 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03623321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.

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