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
Las Vegas, Nevada 89102
874
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from 98109
Las Vegas, NV
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2730
mi
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Miami, FL
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3212 Cove Bend Drive
Tampa, Florida 33613
2522
mi
from 98109
Tampa, FL
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Albuquerque, New Mexico 87109
1183
mi
from 98109
Albuquerque, NM
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Atlanta, Georgia
2178
mi
from 98109
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...
2178
mi
from 98109
Atlanta, GA
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Atlanta, Georgia 30328
?
mi
from 98109
Atlanta, GA
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17800 Woodruff Avenue
Bellflower, California 90706
975
mi
from 98109
Bellflower, CA
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Berlin, New Jersey
2389
mi
from 98109
Berlin, NJ
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?
mi
from 98109
Burgas,
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Cedarhurst, New York 11516
2417
mi
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Cedarhurst, NY
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Charlotte, North Carolina 28204
2282
mi
from 98109
Charlotte, NC
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303 East Superior Street
Chicago, Illinois 60611
1733
mi
from 98109
Chicago, IL
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7906 South Crandon Avenue
Chicago, Illinois 60617
1739
mi
from 98109
Chicago, IL
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Culver City, California 90230
964
mi
from 98109
Culver City, CA
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1959
mi
from 98109
Dayton, OH
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Decatur, Georgia 30030
2182
mi
from 98109
Decatur, GA
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Downingtown, Pennsylvania 19335
2346
mi
from 98109
Downingtown, PA
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Durham, North Carolina 27705
2338
mi
from 98109
Durham, NC
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Hialeah, Florida 33016
2719
mi
from 98109
Hialeah, FL
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Hoffman Estates, Illinois 60169
1704
mi
from 98109
Hoffman Estates, IL
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1670
mi
from 98109
Irving, TX
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80-15 164th Street
Jamaica, New York 11432
2411
mi
from 98109
Jamaica, NY
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Jamaica, New York 11432
?
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Jamaica, NY
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Lake Charles, Louisiana 70601
1954
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Lake Charles, LA
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Lauderhill, Florida 33319
2710
mi
from 98109
Lauderhill, FL
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Lemon Grove, California 91945
1065
mi
from 98109
Lemon Grove, CA
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Little Rock, Arkansas 72211
1782
mi
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Little Rock, AR
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Long Beach, California 90822
982
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Long Beach, CA
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Marietta, Georgia 30060
2163
mi
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Marietta, GA
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2724
mi
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Miami, FL
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National City, California 91950
1069
mi
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National City, CA
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Norwalk, Connecticut 90650
?
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Norwalk, CT
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Oklahoma City, Oklahoma 73116
1518
mi
from 98109
Oklahoma City, OK
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2300 Maitland Center Parkway
Orlando, Florida 32810
2542
mi
from 98109
Orlando, FL
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Phoenix, Arizona 85012
?
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Phoenix, AZ
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Richardson, Texas 75080
1675
mi
from 98109
Richardson, TX
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Rochester, New York 14618
2164
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Rochester, NY
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609 West Dyke Road
Rogers, Arkansas 72758
1634
mi
from 98109
Rogers, AR
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Salt Lake City, Utah 84105
701
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from 98109
Salt Lake City, UT
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San Diego, California 92123
1060
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from 98109
San Diego, CA
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San Diego, California 92123
1060
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San Diego, CA
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Santa Ana, California 92705
926
mi
from 98109
Santa Ana, CA
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12772 Valley View Street
Torrance, California 90502
983
mi
from 98109
Torrance, CA
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?
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from 98109
Wichita, KS
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