Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patient is able to understand and provide signed informed consent
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
Is completing the Week 6 visit in Study ACP-103-034 or the Week 26 visit in Study ACP-103-038 or 064 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
If the subject is female, she must not be pregnant or breastfeeding. She must also 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
The main background antipsychotic with which the subject is being treated must continue to be on one of the antipsychotics listed below:
Aripiprazole
Aripiprazole long-acting injectables:
Asenapine
Risperidone
Risperidone long-acting injection
Olanzapine
Paliperidone extended release (ER) (≤9 mg)
Paliperidone palmitate
Lurasidone
Cariprazine
Brexpiprazole
Asenapine
Exclusion criteria
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 -064)
A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse
Is taking a medication or drug or other substance that is prohibited according to this protocol
Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval
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 study.
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).
Primary purpose
Allocation
Interventional model
Masking
996 participants in 1 patient group
Loading...
Central trial contact
Sandra Filosi; Dragana Bugarski-Kirola, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal