Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:9/30/2018
Start Date:June 2014
End Date:September 2016

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An Open-Label, Long-Term Safety and Tolerability Study of RBP-7000 in the Treatment of Subjects With Schizophrenia

This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with
schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000
subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting
clinical outcome data with RBP-7000 SC injections in subjects with schizophrenia using the
Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Illness
(CGI-S) scale.

Patients to be screened must be diagnosed with schizophrenia with a designated score based on
the PANSS, as confirmed by a State, Assessability, Face, Ecological and Rule (SAFER)
interview. "De novo" patients are patients who are already receiving 3- or 4-mg oral
risperidone/day and will not have to complete the "run-in" or "conversion" phases (see below)
and will be assigned to receive RBP-7000 after eligibility has been confirmed. Patients who
completed the double-blind, placebo-controlled, efficacy study of RBP-7000 (RB-US-09-0010,
NCT02109562), conducted in patients with acute schizophrenia (referred to as "roll-over"
patients) will be screened.

All patients will be assigned the 120 mg dose of RBP-7000, which is subject to a one-time
down-titration to 90-mg RBP-7000 for tolerability, at the investigator's discretion. Patients
receiving the 90-mg dose of RBP-7000 who exhibit a worsening in psychiatric symptoms,
confirmed by a total PANSS score >70 or a 20% increase in the PANSS score from the previous
assessment at the 120-mg dose level (before the dose was decreased to 90 mg), can receive a
one-time, up-titration back to 120-mg RBP-7000 at the discretion of the investigator.

"De novo" patients entering into the study are those patients who did not participate in
study RB-US-09-0010 (NCT02109562) and are allocated into three groups with different
pre-study procedures to prepare for the treatment period:

- "Run-in" patients are patients who are not already receiving oral risperidone (as no
other antipsychotic medications are allowed during study participation) and will begin a
14-day run-in period by titrating up to a dose of 3 or 4 mg oral risperidone/day before
the first injection of RBP-7000.

- "Conversion" patients are patients who are receiving oral risperidone doses other than 3
or 4mg/day and will begin a 7-day conversion period to achieve an oral risperidone dose
level of 3 or 4-mg before the first injection of RBP-7000, only if clinically indicated.

- De novo patients taking an oral risperidone dose of 3 or 4 mg/day prestudy will (once
screened/enrolled) receive the first injection of RBP-7000.

"Roll-over" patients entering into the study are patients who completed 56 days of
double-blind treatment in Study RB-US-09-0010. These patients will be eligible to enter the
current study provided that continuation of treatment is clinically warranted, as judged by
the investigator, and that there have been no significant protocol deviations or clinically
relevant adverse events (AEs) that would preclude inclusion in this study. Roll-over patients
will not undergo the complete screening process and will not require either a run-in or
conversion period with oral risperidone. On Day 1 of the open-label study (which is Day 57 of
Study RB-US-09-0010), patients will receive their first injection (120 mg) of open label
RBP-7000.

Inclusion Criteria:

"De Novo" Patients

- Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4,
text revision (DSM-IV-TR) criteria

- Total PANSS score <=70 at the time of screening (Visit 1)

- Otherwise healthy on the basis of physical examinatIon

- Provided written informed consent

"Roll-over Patients

- Provided written consent to participate in this study

- Be considered eligible to enroll based on End of Study (EOS) (Day 57 of Study
RB-US-09-0010) assessments and the medical judgment of the investigator

Exclusion Criteria:

"De Novo" Patients

- Patients taking daily oral risperidone at a dose plus/minus 6 mg/day

- Patients taking any risperidone or 9-hydroxyrisperidone long-acting injectable
formulation within 120 days of study screening (Visit 1)

- Patients who have received a long-acting injectable antipsychotic within 120 days of
screening (Visit 1)

- Patients with evidence or history (in the past six months prior to screening) of a
significant hepatic disorder that may either compromise patient safety or interfere
with the safety and/or outcome evaluation of the study drug, including:

- Acute or chronic hepatitis, including but not limited to hepatitis B or C

- Total bilirubin greater than 1.5 times the upper limit of normal (ULN), or

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2
times ULN

- Patients with a history of drug-induced leukopenia

- Patients with other medical conditions including, but not limited to, history of heart
attack (myocardial infarction) or brain injury (traumatic injury with loss of
consciousness and/or cerebrovascular accident), and clinically significant low blood
pressure or arrhythmias as interpreted by the primary investigator (PI) or medically
qualified sub-investigator

- Patients with epilepsy or other seizure disorders, Parkinson's disease or dementia

"Roll-over" Patients

- Patients requiring an inpatient treatment setting at the end of Study RB-US-09-0010

- Patients with an unstable medical condition developed during Study RB-US-09-0010

- Women of childbearing potential who have a positive pregnancy test at screening (Visit
1), who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate
contraceptive methods during the study
We found this trial at
48
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Maitland, Florida 32751
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3212 Cutshaw Ave
Richmond, Virginia 23230
804-353-4494
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1100 N. St. Francis
Wichita, Kansas 67214
316-291-4774
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Atlanta, Georgia
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Austin, Texas 78754
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Austin, Texas 78756
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8043 Cooper Creek Boulevard Suite 107
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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Brooklyn, New York 11201
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Cedarhurst, New York 11516
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Cerritos, California 90703
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Charlotte, North Carolina 28204
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Chicago, Illinois 60640
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Dallas, Texas 75231
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Dallas, Texas 75243
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Decatur, Georgia 30030
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Escondido, California 92025
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Fort Lauderdale, Florida 33308
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Glendale, California 91204
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Hickory, North Carolina 28601
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Hoffman Estates, Illinois 60169
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Hollywood, Florida 33021
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Houston, Texas 77024
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Lake Charles, Louisiana 70601
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Las Vegas, Nevada 89102
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Little Rock, Arkansas 72211
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Long Beach, California 90813
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Marlton, New Jersey 08053
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Memphis, Tennessee 38119
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Miami, Florida 33122
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Naperville, Illinois 60563
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Norristown, Pennsylvania 19403
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Norwalk, Connecticut 06851
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Oakland, California 94612
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Oceanside, California 92056
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Pico Rivera, California 90660
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Reading, Pennsylvania 19604
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Rochester, New York 14618
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Springdale, Arkansas 72764
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Washington, District of Columbia 20016
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