search
Back to results

A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Primary Purpose

Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimavanserin
Placebo
Sponsored by
ACADIA Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Can understand the nature of the trial and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:

    1. The subject's legally acceptable representative (LAR) (or study partner/caregiver, if local regulations allow) must provide written informed consent
    2. The subject must provide written (if capable) informed assent

  2. Subject requires some or complete assistance with one or more of the following:

    1. Instrumental activities of daily living (communication, transportation, meal preparation, shopping, housework, managing medications, managing personal finances) OR
    2. Basic activities of daily living (personal hygiene, dressing, eating, maintaining continence or transferring)

  3. Meets clinical criteria for at least one of the following disorders, with or without cerebrovascular disease (CVD):

    1. Parkinson's disease with or without dementia as defined by the Movement Disorder Society's Task Force
    2. Dementia with Lewy bodies (DLB)
    3. All-cause dementia, possible or probable Alzheimer's disease (AD)
    4. Frontotemporal degeneration spectrum disorders, including possible or probable:

    i. Behavioral variant frontotemporal dementia

    ii. Progressive supranuclear palsy

    iii. Corticobasal degeneration

    e. Vascular dementia, including post-stroke dementia multi-infarct dementia and/or subcortical ischemic vascular dementia (SIVD)

  4. Has a designated study partner/caregiver
  5. Can come to the clinic for study visits with a study partner/caregiver
  6. 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.
  7. If the subject is taking an antipsychotic medication at the time of screening, the antipsychotic medication must be discontinued 2 weeks or 5 half-lives (whichever is longer)

Exclusion Criteria:

  1. Is in hospice, is receiving end-of-life palliative care, or is bedridden
  2. Has psychotic symptoms that are primarily attributable to delirium or substance abuse (i.e., neuropsychiatric symptoms not related to neurodegenerative disease)
  3. Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
  4. Has a known personal or family history of long QT syndrome or family history of sudden cardiac death

  5. Has a clinical significant CNS abnormality that is most likely contributing to the dementia or findings on MRI or CT including:

    1. intracranial mass lesion
    2. vascular malformation
    3. evidence of >4 hemosiderin deposits
  6. The urine drug screen result at Visit 1 (Screening) indicates the presence of amphetamine/methamphetamine, barbiturates, cocaine, or phencyclidine (PCP). Subjects who test positive for amphetamines and who have a valid prescription may be retested if they agree to abstain from the medication for the length of their participation in the study. The presence of benzodiazepines, marijuana (THC), or opiates does not necessarily exclude the subject from the study, as assessed by the Investigator in consultation with the Medical Monitor.
  7. Has previously been enrolled in any prior clinical study with pimavanserin or is currently taking pimavanserinIs judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason

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).

Sites / Locations

  • Cognitive Clinical Trials
  • ATP Clinical Research, Inc.
  • Syrentis Clinical Research
  • Indago Research & Health Center Inc
  • Reliable Clinical Research, LLC
  • Axcess Medical Research
  • Premier Clinical Research Institute, Inc.
  • Global Medical Institutes
  • Future Care Solution, LLC
  • MediClear Medical & Research Center, Inc.
  • Novel Clinical Research LLC
  • Laszlo J Mate, MD, PA
  • University of South Florida
  • Synexus Clinical Research US
  • Boston Center Memory
  • Cognitive Clinical Trials LLC
  • The NeuroCognitive Institute
  • UNC Hospital
  • Insight Clinical Trials LLC
  • Suburban Research Associates
  • Central for Biomedical Research, LLC
  • Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero
  • UMHAT Psych clin for gen psychiatry and addictions
  • DCC Sv. Vrach and Sv. Sv. Kozma and Damyan
  • Diagnostic Consultative Centre, 2, N. Vaptzarov Street
  • Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd
  • Mental Health Center Vratza EOOD, 1 Belasitsa St
  • E.S.E. Hospital Mental de Antioquia
  • Centr Investigaciones y Proyectos en Neurociencias
  • Psynapsis Salud Mental S.A.
  • Centro de Investigaciones del Sistema Nervioso
  • BRAIN-SOULTHERAPY s.r.o., , Lekarna Jalta, Namesti Jana Masaryka 3113
  • Fakultni nemocnice Olomouc
  • A-shine s.r.o./ Lekarna Centrum
  • AD71, s.r.o.,/Hostivarska Iekarna
  • Axon Clinical
  • Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1
  • AD71, s.r.o., /,Lekarna DPS Recruiting
  • Petre Sarajishvili Institute of Neurology LLC
  • Pineo Medical Ecosystem LTD
  • Tbilisi Heart and Vascular Clinic LTD
  • Health Institute LLC
  • S. Khechinashvili University Hospital LLC
  • Hospital Universitario Saltillo
  • Instituto Nacional de Neurologia y Neurocirugia
  • Centro Regional para Adulto Mayor, Hsp Univ, JEG
  • Clinicos y Especialidades Medicas
  • Christus Muguerza Hospital Sur
  • Neurologi ZOZ Cntr Leczenia SM Badan Klinicznych
  • MlynowaMed SP Psych Dr. Joanna Lazarcyck
  • Wlokiennicza Me Sp Prak Lekarska Dromasz Markowski
  • Przychodnia Srodmiescie Sp. z.o.o.
  • ISPL Wieslaw Jerzy Cubala
  • NZOZ Wielospecjalistyczna Poradnia Lekarska Synap
  • Silmedic Sp. z.o.o.
  • Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3
  • Centrum Medyczne HCP Sp. z.o.o.
  • NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz
  • Neuro-Care Sp. z.o.o. sp. Komandytowa
  • Neuro-care
  • RCMed Oddzial Sochaczew, ul. _eromskiego 41A
  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
  • Spitalul clinic CF Constanta, Sectia Neurologie
  • Med Anima SRL, Clinica de psihiatrie
  • S.C. Carpe Diem SRL
  • Regional Specialized Psychiatric Hospital #2
  • Federal Siberian Sci Clinical Center of Med and Bio
  • Clinic "Hundred Years"
  • Mental Health Research Center
  • City Clinical Hospital #34
  • Leningrad Regional Psychoneurological Dispensary
  • St. Nicholas the Wonder Worker Psychiatric Hospital
  • FSBI NMRC PN n.a. V.M. Bekhterev
  • City Psychiatric Hospital #3
  • Samara Psychiatric Hospital
  • Saratov City Clinical Hospital V. I. Razumovsky
  • Smolensk State Medical University
  • Stavropol Regional Clin Spec Psych Hospital #1
  • CHC Dr Dragisa Misovic- Dedinje
  • Clinical Center of Serbia, Clinic for Psychiatry
  • Military Medical Academy
  • Clinic for Psychiatric Diseases Dr. Laza Lazarevic
  • Klinicki Centar Srbije (KCS)- Klinika za nerurologiju
  • Special Hospital for Psychiatric Diseases "Kovin"
  • Clinical Center Kragujevac, Clinic for Neurology
  • Clinical Center Kragujevac, Clinic of Psychiatry
  • Clinical Center Nis, Clinic for Psychiatry
  • General Hospital Valjevo, Department for Neurology
  • Neurology Practice
  • Dr. Stanley Lipshitz Clinic Inc.
  • Flexivest Fourteen Research Centre Potocnik F C V
  • Dnipr Regional Clinical Hospital n.a. Mechnikov
  • I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital
  • Dnipropetrovsk Regional Rehabilitation Hospital
  • Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital
  • Institute of Neruology, Nat Acad of Med Sci of UKR
  • Institute of Neurology
  • Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str
  • Kyiv Regional Medical Incorp. Psychiatria, Center
  • Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str
  • Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.
  • 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, 109 Pyrogova str.
  • Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology
  • Zaporizhzhya Reg. Hospital, Neurology Dpt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug - Pimavanserin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Treatment-emergent adverse events (TEAEs)
Safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease

Secondary Outcome Measures

Change from Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)
Change from Baseline to Week 8 in Mini-Mental State Examination (MMSE)

Full Information

First Posted
June 9, 2018
Last Updated
August 12, 2022
Sponsor
ACADIA Pharmaceuticals Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03575052
Brief Title
A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Official Title
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Safety Study of Pimavanserin Therapy in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
May 6, 2022 (Actual)
Study Completion Date
May 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropsychiatric Symptoms Related to Neurodegenerative Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
784 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug - Pimavanserin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Intervention Description
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, tablets, once daily by mouth (provided as two placebo tablets)
Primary Outcome Measure Information:
Title
Treatment-emergent adverse events (TEAEs)
Description
Safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease
Time Frame
Treatment Period: 8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)
Time Frame
Treatment Period: 8 weeks
Title
Change from Baseline to Week 8 in Mini-Mental State Examination (MMSE)
Time Frame
Treatment Period: 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Can understand the nature of the trial and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met: The subject's legally acceptable representative (LAR) (or study partner/caregiver, if local regulations allow) must provide written informed consent The subject must provide written (if capable) informed assent Subject requires some or complete assistance with one or more of the following: Instrumental activities of daily living (communication, transportation, meal preparation, shopping, housework, managing medications, managing personal finances) OR Basic activities of daily living (personal hygiene, dressing, eating, maintaining continence or transferring) Meets clinical criteria for at least one of the following disorders, with or without cerebrovascular disease (CVD): Parkinson's disease with or without dementia as defined by the Movement Disorder Society's Task Force Dementia with Lewy bodies (DLB) All-cause dementia, possible or probable Alzheimer's disease (AD) Frontotemporal degeneration spectrum disorders, including possible or probable: i. Behavioral variant frontotemporal dementia ii. Progressive supranuclear palsy iii. Corticobasal degeneration e. Vascular dementia, including post-stroke dementia multi-infarct dementia and/or subcortical ischemic vascular dementia (SIVD) Has a designated study partner/caregiver Can come to the clinic for study visits with a study partner/caregiver 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. If the subject is taking an antipsychotic medication at the time of screening, the antipsychotic medication must be discontinued 2 weeks or 5 half-lives (whichever is longer) Exclusion Criteria: Is in hospice, is receiving end-of-life palliative care, or is bedridden Has psychotic symptoms that are primarily attributable to delirium or substance abuse (i.e., neuropsychiatric symptoms not related to neurodegenerative disease) Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study Has a known personal or family history of long QT syndrome or family history of sudden cardiac death Has a clinical significant CNS abnormality that is most likely contributing to the dementia or findings on MRI or CT including: intracranial mass lesion vascular malformation evidence of >4 hemosiderin deposits The urine drug screen result at Visit 1 (Screening) indicates the presence of amphetamine/methamphetamine, barbiturates, cocaine, or phencyclidine (PCP). Subjects who test positive for amphetamines and who have a valid prescription may be retested if they agree to abstain from the medication for the length of their participation in the study. The presence of benzodiazepines, marijuana (THC), or opiates does not necessarily exclude the subject from the study, as assessed by the Investigator in consultation with the Medical Monitor. Has previously been enrolled in any prior clinical study with pimavanserin or is currently taking pimavanserinIs judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason 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).
Facility Information:
Facility Name
Cognitive Clinical Trials
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85296
Country
United States
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Indago Research & Health Center Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Reliable Clinical Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Axcess Medical Research
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Premier Clinical Research Institute, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Global Medical Institutes
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Future Care Solution, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
MediClear Medical & Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Novel Clinical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Laszlo J Mate, MD, PA
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Synexus Clinical Research US
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Boston Center Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Cognitive Clinical Trials LLC
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
The NeuroCognitive Institute
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Facility Name
UNC Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Insight Clinical Trials LLC
City
Shaker Heights
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Central for Biomedical Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Centre for Mental Health Prof. Dr. Ivan Temkov, Lazur Compl., Park Ezero
City
Bourgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
UMHAT Psych clin for gen psychiatry and addictions
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
DCC Sv. Vrach and Sv. Sv. Kozma and Damyan
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Diagnostic Consultative Centre, 2, N. Vaptzarov Street
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Diagnostic Consultative Centre-Mladost-Psychiatry, 15, Republika Blvd
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Mental Health Center Vratza EOOD, 1 Belasitsa St
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
E.S.E. Hospital Mental de Antioquia
City
Bello
State/Province
Antioquia
ZIP/Postal Code
51053
Country
Colombia
Facility Name
Centr Investigaciones y Proyectos en Neurociencias
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Psynapsis Salud Mental S.A.
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
66001
Country
Colombia
Facility Name
Centro de Investigaciones del Sistema Nervioso
City
Bogota
ZIP/Postal Code
111166
Country
Colombia
Facility Name
BRAIN-SOULTHERAPY s.r.o., , Lekarna Jalta, Namesti Jana Masaryka 3113
City
Kladno
ZIP/Postal Code
27204
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
A-shine s.r.o./ Lekarna Centrum
City
Plzen
ZIP/Postal Code
31200
Country
Czechia
Facility Name
AD71, s.r.o.,/Hostivarska Iekarna
City
Praha 10
ZIP/Postal Code
10200
Country
Czechia
Facility Name
Axon Clinical
City
Praha 5
ZIP/Postal Code
1500
Country
Czechia
Facility Name
Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1
City
Praha 6
ZIP/Postal Code
16010
Country
Czechia
Facility Name
AD71, s.r.o., /,Lekarna DPS Recruiting
City
Říčany
ZIP/Postal Code
25101
Country
Czechia
Facility Name
Petre Sarajishvili Institute of Neurology LLC
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Pineo Medical Ecosystem LTD
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Facility Name
Tbilisi Heart and Vascular Clinic LTD
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Health Institute LLC
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
S. Khechinashvili University Hospital LLC
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Hospital Universitario Saltillo
City
Saltillo
State/Province
Coahuila
ZIP/Postal Code
25000
Country
Mexico
Facility Name
Instituto Nacional de Neurologia y Neurocirugia
City
Ciudad de Mexico
State/Province
Delegacion Tlalpan
ZIP/Postal Code
14269
Country
Mexico
Facility Name
Centro Regional para Adulto Mayor, Hsp Univ, JEG
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Clinicos y Especialidades Medicas
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64620
Country
Mexico
Facility Name
Christus Muguerza Hospital Sur
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64988
Country
Mexico
Facility Name
Neurologi ZOZ Cntr Leczenia SM Badan Klinicznych
City
Plewiska
State/Province
Poznan
ZIP/Postal Code
62-064
Country
Poland
Facility Name
MlynowaMed SP Psych Dr. Joanna Lazarcyck
City
Bialystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
Wlokiennicza Me Sp Prak Lekarska Dromasz Markowski
City
Białystok
ZIP/Postal Code
15-464
Country
Poland
Facility Name
Przychodnia Srodmiescie Sp. z.o.o.
City
Bydgoszcz
ZIP/Postal Code
85-080
Country
Poland
Facility Name
ISPL Wieslaw Jerzy Cubala
City
Gdańsk
ZIP/Postal Code
80-438
Country
Poland
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska Synap
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Silmedic Sp. z.o.o.
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3
City
Kraków
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Centrum Medyczne HCP Sp. z.o.o.
City
Poznań
ZIP/Postal Code
61-485
Country
Poland
Facility Name
NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz
City
Pruszcz Gdański
ZIP/Postal Code
83-000
Country
Poland
Facility Name
Neuro-Care Sp. z.o.o. sp. Komandytowa
City
Siemianowice Śląskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
Neuro-care
City
Siemianowice Śląskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
RCMed Oddzial Sochaczew, ul. _eromskiego 41A
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400012
Country
Romania
Facility Name
Spitalul clinic CF Constanta, Sectia Neurologie
City
Constanta
ZIP/Postal Code
900123
Country
Romania
Facility Name
Med Anima SRL, Clinica de psihiatrie
City
Iasi
ZIP/Postal Code
700004
Country
Romania
Facility Name
S.C. Carpe Diem SRL
City
Sibiu
ZIP/Postal Code
550281
Country
Romania
Facility Name
Regional Specialized Psychiatric Hospital #2
City
Tonnel'nyy
State/Province
Kochubeev District
ZIP/Postal Code
357034
Country
Russian Federation
Facility Name
Federal Siberian Sci Clinical Center of Med and Bio
City
Krasnoyarsk
State/Province
Krasnoyarksk Region
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Clinic "Hundred Years"
City
Tomsk
State/Province
Tomsk Region
ZIP/Postal Code
634009
Country
Russian Federation
Facility Name
Mental Health Research Center
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
City Clinical Hospital #34
City
Novosibirsk
ZIP/Postal Code
630054
Country
Russian Federation
Facility Name
Leningrad Regional Psychoneurological Dispensary
City
Roshchino
ZIP/Postal Code
188820
Country
Russian Federation
Facility Name
St. Nicholas the Wonder Worker Psychiatric Hospital
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
FSBI NMRC PN n.a. V.M. Bekhterev
City
Saint Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
City Psychiatric Hospital #3
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Samara Psychiatric Hospital
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Facility Name
Saratov City Clinical Hospital V. I. Razumovsky
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Smolensk State Medical University
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Stavropol Regional Clin Spec Psych Hospital #1
City
Stavropol'
ZIP/Postal Code
355038
Country
Russian Federation
Facility Name
CHC Dr Dragisa Misovic- Dedinje
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center of Serbia, Clinic for Psychiatry
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinic for Psychiatric Diseases Dr. Laza Lazarevic
City
Belgrade
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Klinicki Centar Srbije (KCS)- Klinika za nerurologiju
City
Belgrade
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Special Hospital for Psychiatric Diseases "Kovin"
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Facility Name
Clinical Center Kragujevac, Clinic for Neurology
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Kragujevac, Clinic of Psychiatry
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Nis, Clinic for Psychiatry
City
Toponica
ZIP/Postal Code
18202
Country
Serbia
Facility Name
General Hospital Valjevo, Department for Neurology
City
Valjevo
ZIP/Postal Code
14000
Country
Serbia
Facility Name
Neurology Practice
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0014
Country
South Africa
Facility Name
Dr. Stanley Lipshitz Clinic Inc.
City
Sandton
State/Province
Gauteng
ZIP/Postal Code
2146
Country
South Africa
Facility Name
Flexivest Fourteen Research Centre Potocnik F C V
City
Durbanville
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Dnipr Regional Clinical Hospital n.a. Mechnikov
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Dnipropetrovsk Regional Rehabilitation Hospital
City
Dnipro
ZIP/Postal Code
49128
Country
Ukraine
Facility Name
Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Institute of Neruology, Nat Acad of Med Sci of UKR
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Institute of Neurology
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Municipal Non-Commercial Institution of Kharkiv Regional Council "Kharkiv Regional Clinical Psychiatric Hospital # 3" 46, Ac. Pavlova str
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kyiv Regional Medical Incorp. Psychiatria, Center
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Kyiv Regional Psychiatric and Narcological Medical Association 8, Vokzalna str
City
Kyiv
ZIP/Postal Code
8630
Country
Ukraine
Facility Name
Ternopil Regional Communal Clinical Psychoneurological Hospital 14, Troleibusna str.
City
Ternopil'
ZIP/Postal Code
46027
Country
Ukraine
Facility Name
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, 109 Pyrogova str.
City
Vinnytsia
ZIP/Postal Code
21037
Country
Ukraine
Facility Name
Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Zaporizhzhya Reg. Hospital, Neurology Dpt
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease

We'll reach out to this number within 24 hrs