Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression



Status:Recruiting
Conditions:Depression, Depression, Parkinsons Disease
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - Any
Updated:3/27/2019
Start Date:March 9, 2018
End Date:May 2019
Contact:Rene Nunez, MD
Email:rnunez@ACADIA-Pharm.com
Phone:609-250-6943

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An Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and Depression

The purpose of this study is to assess the efficacy of pimavanserin for the treatment of
depression in adults with Parkinson's disease.


Inclusion Criteria:

1. Can understand and provide signed informed consent, request for medical records and/or
subject privacy form if applicable according to local regulations

2. Has a clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of
1 year, defined as the presence of at least three of the following cardinal features,
in the absence of alternative explanations or atypical features:

1. rest tremor

2. rigidity

3. bradykinesia and/or akinesia

4. postural and gait abnormalities

3. Meets clinical criteria for depression with Parkinson's disease as listed in the
NINDS/NIMH Guidelines

4. If currently taking an anti-depressant, is being treated with only one SSRI or SNRI
antidepressant at a dose within the US FDA-approved dose range. Subjects who are
currently taking a second antidepressant or antidepressant augmentation agent at a
sub-therapeutic dose or for an inadequate duration at Screening, and can be
discontinued from this agent before the Baseline visit (in the opinion of the
Investigator), may be eligible for the study.

5. Is on a stable dose of anti-Parkinson's medication for 1 month prior to Screening

6. If the subject is female, she must be of non-childbearing potential or agree to use
two methods of clinically acceptable contraception

Exclusion Criteria:

1. Use of an antipsychotic within 3 weeks or 5 half-lives of Baseline (whichever is
longer)

2. Had a myocardial infarction within the 6 months prior to Screening

3. Has a known personal or family history or symptoms of long QT syndrome

4. Evidence of severe or medically significant hepatic or renal impairment on laboratory
tests as assessed by the Investigator or Medical Monitor

5. Has a history of PD psychosis, schizophrenia, or other psychotic disorder, or bipolar
I or II disorder.

6. Actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)

7. Is pregnant or breastfeeding

8. Has previously been treated with pimavanserin or is currently taking pimavanserin

9. Has a sensitivity to pimavanserin or its excipients

10. Is judged by the Investigator or the Medical Monitor to be inappropriate for the study

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to
ensure that all criteria for study participation are met.
We found this trial at
21
sites
Commack, New York 11725
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Albany, NY
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Asheville, North Carolina 28806
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Asheville, NC
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Boca Raton, FL
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Costa Mesa, California 92626
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Costa Mesa, CA
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Danbury, Connecticut 06810
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Danbury, CT
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Fountain Valley, California 92708
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Johnstown, Pennsylvania 15904
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Johnstown, PA
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Kirkland, Washington 98034
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Kirkland, WA
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Pasadena, California 91105
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Pasadena, CA
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Plymouth, MI
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2895 North Towne Avenue
Pomona, California 91767
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Pomona, CA
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Port Charlotte, FL
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Reseda, California 91335
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Reseda, CA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Spokane, Washington 99202
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Spokane, WA
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Sunrise, Florida 33351
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Sunrise, FL
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Tallahassee, Florida 32308
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Toms River, New Jersey 08755
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Toms River, NJ
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Torrance, California 90502
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Torrance, CA
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