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A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

Primary Purpose

Parkinson's Disease Psychosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimavanserin tartrate (ACP-103)
Sponsored by
ACADIA Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease Psychosis focused on measuring Parkinson's Disease Psychosis

Eligibility Criteria

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

Inclusion Criteria:

  • Subject has completed the treatment period of a previous blinded study of pimavanserin
  • The subject is willing and able to provide consent
  • Caregiver is willing and able to accompany the subject to all visits

Exclusion Criteria:

  • Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
  • Subject is judged by the Investigator to be inappropriate for the study

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pimavanserin tartrate (ACP-103)

Arm Description

Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects

Outcomes

Primary Outcome Measures

Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)

Secondary Outcome Measures

Full Information

First Posted
October 26, 2007
Last Updated
May 29, 2019
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00550238
Brief Title
A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Official Title
A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (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
No

5. Study Description

Brief Summary
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
Detailed Description
This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have "completed" the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease Psychosis
Keywords
Parkinson's Disease Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
459 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pimavanserin tartrate (ACP-103)
Arm Type
Experimental
Arm Description
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Intervention Type
Drug
Intervention Name(s)
Pimavanserin tartrate (ACP-103)
Intervention Description
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Primary Outcome Measure Information:
Title
Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Description
Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)
Time Frame
From first to last study drug dose plus 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has completed the treatment period of a previous blinded study of pimavanserin The subject is willing and able to provide consent Caregiver is willing and able to accompany the subject to all visits Exclusion Criteria: Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder Subject is judged by the Investigator to be inappropriate for the study
Facility Information:
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
84724
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United States
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
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United States
City
Carson
State/Province
California
ZIP/Postal Code
90746
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United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
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United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
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United States
City
Irvine
State/Province
California
ZIP/Postal Code
92697
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United States
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
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United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
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United States
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
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United States
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
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United States
City
Reseda
State/Province
California
ZIP/Postal Code
91335
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United States
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
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United States
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
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United States
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
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United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
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United States
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Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
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United States
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Bradenton
State/Province
Florida
ZIP/Postal Code
34205
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United States
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Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
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United States
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Gainesville
State/Province
Florida
ZIP/Postal Code
32610
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United States
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
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United States
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Miami
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Florida
ZIP/Postal Code
33136
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United States
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Naples
State/Province
Florida
ZIP/Postal Code
34102
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United States
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Orlando
State/Province
Florida
ZIP/Postal Code
32806
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United States
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Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
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United States
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
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United States
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Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
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United States
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Sarasota
State/Province
Florida
ZIP/Postal Code
34233
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United States
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Tampa
State/Province
Florida
ZIP/Postal Code
33606
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United States
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Augusta
State/Province
Georgia
ZIP/Postal Code
30912
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United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
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United States
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
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United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
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United States
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Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
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United States
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Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
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United States
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Scarborough
State/Province
Maine
ZIP/Postal Code
04074
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United States
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Baltimore
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Maryland
ZIP/Postal Code
21287
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United States
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Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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United States
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Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
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United States
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Clinton Township
State/Province
Michigan
ZIP/Postal Code
48037
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United States
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Detroit
State/Province
Michigan
ZIP/Postal Code
48201
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United States
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East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
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United States
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
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United States
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Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
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United States
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West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48334
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United States
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Columbia
State/Province
Missouri
ZIP/Postal Code
65201
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United States
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Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
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United States
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Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
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United States
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Albany
State/Province
New York
ZIP/Postal Code
12208
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United States
City
Commack
State/Province
New York
ZIP/Postal Code
11725
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United States
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Kingston
State/Province
New York
ZIP/Postal Code
12401
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United States
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Rochester
State/Province
New York
ZIP/Postal Code
14618
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United States
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Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
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United States
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Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
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United States
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Durham
State/Province
North Carolina
ZIP/Postal Code
27705
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United States
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New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
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United States
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Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
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United States
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Cincinnati
State/Province
Ohio
ZIP/Postal Code
45210
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United States
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Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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United States
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Columbus
State/Province
Ohio
ZIP/Postal Code
43210
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United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
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United States
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Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
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United States
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Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
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United States
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Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
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United States
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Houston
State/Province
Texas
ZIP/Postal Code
77030
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United States
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Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
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United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
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United States
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22311
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United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
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United States
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
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United States
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Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
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United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
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United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
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United States
City
Innsbruck
ZIP/Postal Code
6020
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Austria
City
Vienna
ZIP/Postal Code
1090
Country
Austria
City
Roeselare
ZIP/Postal Code
8800
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Belgium
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
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Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 4G3
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Canada
City
Clermont Ferrand
ZIP/Postal Code
63003
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France
City
Marseille
ZIP/Postal Code
13385
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France
City
Nantes Cedex
ZIP/Postal Code
44093
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France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
City
Bangalore
ZIP/Postal Code
560 034
Country
India
City
Chennai
ZIP/Postal Code
600 006
Country
India
City
Hyderabad
ZIP/Postal Code
500003
Country
India
City
Madurai
ZIP/Postal Code
625 020
Country
India
City
Mangalore
ZIP/Postal Code
575 001
Country
India
City
Mangalore
ZIP/Postal Code
575 002
Country
India
City
Mumbai
ZIP/Postal Code
400 016
Country
India
City
Mumbai
ZIP/Postal Code
400 026
Country
India
City
Pune
ZIP/Postal Code
411 004
Country
India
City
Pune
ZIP/Postal Code
411 030
Country
India
City
Visakhapatnam
ZIP/Postal Code
530 002
Country
India
City
Chieti
ZIP/Postal Code
66013
Country
Italy
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
City
Rome
ZIP/Postal Code
00163
Country
Italy
City
Rome
ZIP/Postal Code
00185
Country
Italy
City
Bydgoszcz
ZIP/Postal Code
85796
Country
Poland
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-028
Country
Portugal
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
City
Kazan
ZIP/Postal Code
420061
Country
Russian Federation
City
Kirov
ZIP/Postal Code
610014
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
City
Pyatigorsk
ZIP/Postal Code
357538
Country
Russian Federation
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
City
Stockholm
ZIP/Postal Code
SE-112 45
Country
Sweden
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
City
Kiev
ZIP/Postal Code
04080
Country
Ukraine
City
Kiev
ZIP/Postal Code
04114
Country
Ukraine
City
Lugansk
ZIP/Postal Code
91045
Country
Ukraine
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
City
Vinnitsia
ZIP/Postal Code
21005
Country
Ukraine
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
City
Blackburn
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
City
London
ZIP/Postal Code
NW3 20G
Country
United Kingdom
City
Newcastle
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
City
North Shields
ZIP/Postal Code
NE21 8NH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28493654
Citation
Mathis MV, Muoio BM, Andreason P, Avila AM, Farchione T, Atrakchi A, Temple RJ. The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin. J Clin Psychiatry. 2017 Jun;78(6):e668-e673. doi: 10.4088/JCP.16r11119.
Results Reference
background
PubMed Identifier
26239690
Citation
Ballard C, Isaacson S, Mills R, Williams H, Corbett A, Coate B, Pahwa R, Rascol O, Burn DJ. Impact of Current Antipsychotic Medications on Comparative Mortality and Adverse Events in People With Parkinson Disease Psychosis. J Am Med Dir Assoc. 2015 Oct 1;16(10):898.e1-7. doi: 10.1016/j.jamda.2015.06.021. Epub 2015 Aug 1.
Results Reference
derived

Learn more about this trial

A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

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