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

Primary Purpose

Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimavanserin
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. 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).

-

Sites / Locations

  • Cognitive Clinical Trials
  • ATP Clinical Research, Inc.
  • Syrentis Clinical Research
  • Indago Research & Health Center Inc
  • Reliable Clinical Research, LLC
  • 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
  • Synexus Clinical Research US, Inc.
  • 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
  • A-shine s.r.o./ Lekarna Centrum
  • Axon Clinical
  • Neuropsychiatrie, s.r.o., Lekarna 6ka, Fajtlova 1
  • AD71, s.r.o./Hostivarska lekarna
  • 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
  • Clinicos y Especialidades Medicas
  • Christus Muguerza Hospital Sur
  • MlynowaMed Sp Psych Dr. Joanna Lazarczyk
  • Wlokienniecza Med Sp Prak Lekarska Dromasz Markowski
  • Przychodnia Srodmiescie Sp. z.o.o.
  • ISPL Wieslaw Jerzy Cubala
  • NZOZ Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz
  • Krakowska Ak Neuro Sp.- Centrum Neuro Klinicznej, ul. Arianska 7/3
  • Centrum Medyczne HCP Sp. zo.o
  • Neuro-Care Sp. zo.o. sp. Komandytowa
  • Neuro-care
  • RCMed Oddzial Sochaczew, ul. _eromskiego 41A
  • 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
  • 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
  • Samara Psychiatric Hospital
  • Saratov City Clinical Hospital V. I. Razumovsky
  • Stavropol Regional Clin Spec Psych Hospital #1
  • Clinic "Hundred Years"
  • CHC Dr Dragisa Misovic- Dedinje
  • Clinical Center of Serbia, Clinic for Psychiatry
  • Clinical Center of Serbia,Clinic for Neurology
  • 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
  • Flexivest Fourteen Research Centre Potocnik F C V
  • Dnipropetrovsk Regional Rehabilitation Hospital
  • Dnir. Regional Clinical Hospital n.a. Mechnikov
  • 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., Glevakha
  • 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, Department of Psychiatry, Narcology and Psychotherapeutics
  • Municipal Unst Zaporizhzhya Reg Clinical Hosp Neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug - pimavanserin

Arm Description

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.

Outcomes

Primary Outcome Measures

• Treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Full Information

First Posted
August 7, 2018
Last Updated
May 2, 2023
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03623321
Brief Title
Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Official Title
A 52-Week Open-label Extension Study of Pimavanserin in Adult and Elderly Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

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 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.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
597 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug - pimavanserin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Intervention Description
• 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 Measure Information:
Title
• Treatment-emergent adverse events (TEAEs)
Time Frame
Treatment period and Follow-up period: 56 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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). -
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
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
Synexus Clinical Research US, Inc.
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
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
051053
Country
Colombia
Facility Name
Centr Investigaciones y Proyectos en Neurociencias
City
Barranquilla
State/Province
Atlántico
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
Bogotá
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
A-shine s.r.o./ Lekarna Centrum
City
Plzen
ZIP/Postal Code
31200
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./Hostivarska lekarna
City
Praha
ZIP/Postal Code
10200
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
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
MlynowaMed Sp Psych Dr. Joanna Lazarczyk
City
Białystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
Wlokienniecza Med 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 Syntonia Poradnia Zdrowia Psychicznego, ul. Cyprysowa 2F/ 9,10, Pruszcz
City
Gdańsk
ZIP/Postal Code
83-000
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. zo.o
City
Poznań
ZIP/Postal Code
61-485
Country
Poland
Facility Name
Neuro-Care Sp. zo.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 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
ZIP/Postal Code
660037
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
1931167
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
Stavropol Regional Clin Spec Psych Hospital #1
City
Stavropol'
ZIP/Postal Code
355038
Country
Russian Federation
Facility Name
Clinic "Hundred Years"
City
Tomsk
ZIP/Postal Code
634009
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
Clinical Center of Serbia,Clinic for Neurology
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
Flexivest Fourteen Research Centre Potocnik F C V
City
Durban
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Dnipropetrovsk Regional Rehabilitation Hospital
City
Dnipro
ZIP/Postal Code
49000
Country
Ukraine
Facility Name
Dnir. Regional Clinical Hospital n.a. Mechnikov
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Ivano-Frankivsk Nat Med Uni Dep Psychiatry, Regional Hospital
City
Ivano-Frankivs'k
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., Glevakha
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, Department of Psychiatry, Narcology and Psychotherapeutics
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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