Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia



Status:Recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:December 2016
End Date:May 2021
Contact:Dragana Bugarski-Kirola, MD
Email:dbugarski-kirola@acadia-pharm.com
Phone:609-250-6903

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A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of
adjunctive treatment in subjects with schizophrenia


Inclusion Criteria:

1. Patient is able to understand and provide signed informed consent

2. Has a caregiver or some other identified responsible person (e.g., family member,
social worker, caseworker, or nurse) considered reliable by the Investigator in
providing support to the subject to help ensure compliance with study treatment, study
visits, and protocol procedures and who is also able to provide input helpful for
completing study rating scale

3. Is completing the Week 6 visit in Study ACP-103-034 or -039 or the Week 26 visit in
Study ACP-103-038 while continuing to take his/her assigned dose of blinded study drug
and may, in the Investigator's opinion, benefit from continued adjunctive treatment
with pimavanserin to a antipsychotic

4. If female, must be of non-childbearing potential (defined as either surgically
sterilized or at least 1 year postmenopausal) or must agree to use two clinically
acceptable methods of contraception

5. The main background antipsychotic with which the subject is being treated must
continue be one of the antipsychotics listed below:

- Aripiprazole

- Aripiprazole long-acting injectables:

- Abilify Maintena®

- Aristada®

- Asenapine

- Risperidone

- Risperidone long-acting injection

- Olanzapine

- Lurasidone

- Cariprazine

- Brexpiprazole

- Asenapine

Exclusion Criteria:

1. Patient is judged by the Investigator or the Medical Monitor to be inappropriate for
the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -039)

2. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested
prohibited substance of potential abuse, except marijuana

a. Patients with a result indicating the presence of marijuana are permitted if they
agree to abstain from marijuana use during the study and the medical monitor approves
the subject's participation

3. Is taking a medication or drug or other substance that is prohibited according to this
protocol

4. Known family or personal history or symptoms of long QT syndrome

5. Patient has current evidence of a serious and/or unstable psychiatric, neurologic,
cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other
medical disorder, including cancer or malignancies, which would affect the patient's
ability to participate in the program.

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).
We found this trial at
45
sites
Culver City, California 90230
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3212 Cove Bend Drive
Tampa, Florida 33613
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Albuquerque, New Mexico 87109
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Atlanta, Georgia
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Atlanta, GA
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Atlanta, Georgia 30328
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17800 Woodruff Avenue
Bellflower, California 90706
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Berlin, New Jersey
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Berlin, NJ
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Burgas,
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Cedarhurst, New York 11516
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Charlotte, North Carolina 28204
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Charlotte, NC
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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7906 South Crandon Avenue
Chicago, Illinois 60617
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Chicago, IL
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Dayton, OH
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Decatur, Georgia 30030
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Downingtown, Pennsylvania 19335
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Durham, North Carolina 27705
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Hialeah, Florida 33016
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Hoffman Estates, Illinois 60169
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Irving, TX
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80-15 164th Street
Jamaica, New York 11432
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Jamaica, New York 11432
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Lake Charles, Louisiana 70601
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Las Vegas, Nevada 89102
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Lauderhill, Florida 33319
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Lemon Grove, California 91945
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Little Rock, Arkansas 72211
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Long Beach, California 90822
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Marietta, Georgia 30060
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National City, California 91950
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Norwalk, Connecticut 90650
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Oklahoma City, Oklahoma 73116
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Oklahoma City, OK
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2300 Maitland Center Parkway
Orlando, Florida 32810
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Phoenix, Arizona 85012
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Richardson, Texas 75080
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Rochester, New York 14618
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609 West Dyke Road
Rogers, Arkansas 72758
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Salt Lake City, Utah 84105
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San Diego, California 92123
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San Diego, California 92123
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Santa Ana, California 92705
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12772 Valley View Street
Torrance, California 90502
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Wichita, KS
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