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

Use our guide to learn which trials are right for you!

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
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
3212 Cove Bend Drive
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Atlanta, Georgia
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30328
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
17800 Woodruff Avenue
Bellflower, California 90706
?
mi
from
Bellflower, CA
Click here to add this to my saved trials
Berlin, New Jersey
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
?
mi
from
Burgas,
Click here to add this to my saved trials
Cedarhurst, New York 11516
?
mi
from
Cedarhurst, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
7906 South Crandon Avenue
Chicago, Illinois 60617
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Culver City, California 90230
?
mi
from
Culver City, CA
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30030
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Downingtown, Pennsylvania 19335
?
mi
from
Downingtown, PA
Click here to add this to my saved trials
Durham, North Carolina 27705
?
mi
from
Durham, NC
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hoffman Estates, Illinois 60169
?
mi
from
Hoffman Estates, IL
Click here to add this to my saved trials
?
mi
from
Irving, TX
Click here to add this to my saved trials
80-15 164th Street
Jamaica, New York 11432
?
mi
from
Jamaica, NY
Click here to add this to my saved trials
Jamaica, New York 11432
?
mi
from
Jamaica, NY
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lauderhill, Florida 33319
?
mi
from
Lauderhill, FL
Click here to add this to my saved trials
Lemon Grove, California 91945
?
mi
from
Lemon Grove, CA
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90822
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
National City, California 91950
?
mi
from
National City, CA
Click here to add this to my saved trials
Norwalk, Connecticut 90650
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
2300 Maitland Center Parkway
Orlando, Florida 32810
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Richardson, Texas 75080
?
mi
from
Richardson, TX
Click here to add this to my saved trials
Rochester, New York 14618
?
mi
from
Rochester, NY
Click here to add this to my saved trials
609 West Dyke Road
Rogers, Arkansas 72758
?
mi
from
Rogers, AR
Click here to add this to my saved trials
Salt Lake City, Utah 84105
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
12772 Valley View Street
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials