Summary

for people ages 18-65 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

The purpose of the study is to evaluate the efficacy, safety, and tolerability of different dose regimens of TV-46000 administered subcutaneously as compared to placebo during maintenance treatment in adult patients with schizophrenia. The study will include male and female patients, 18 to 65 years of age, who have a confirmed diagnosis of schizophrenia, are clinically stable, and are eligible for risperidone treatment.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult Patients With Schizophrenia

Keywords

Schizophrenia Risperidone TV-46000 - A TV-46000 - B

Eligibility

You can join if…

Open to people ages 18-65

  • The patient has a diagnosis of schizophrenia for >1 year and has had ≥1 episode of relapse in the last 24 months.
  • The patient has been responsive to an antipsychotic treatment (other than clozapine)in the past year based on discussions with family members or healthcare professionals.
  • The patient has a stable place of residence for the previous 3 months before screening, and changes in residence are not anticipated over the course of study participation.
  • The patient has no significant life events that could affect study outcomes expected throughout the period of study participation.
  • Women of childbearing potential must agree not to try to become pregnant, and, unless they have exclusively same-sex partners, must agree to use a highly effective method of contraception, and agree to continue use of this method beginning 1 month before the first administration of study drugs and for the duration of the study and for 120 days after the last injection of study drug.
  • The patient, if male, is surgically sterile, or, if capable of producing offspring, or has exclusively same-sex partners or is currently using an approved method of birth control and agrees to the continued use of this method for the duration of the study(and for 120 days after the last dose of study drug). Male patients with sex partners who are women of childbearing potential must use condoms even if surgically sterile
  • Additional criteria apply, please contact the investigator for more information

You CAN'T join if...

  • The patient has a current clinically significant Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium,dementia, or amnestic or other cognitive disorders, or borderline, paranoid,histrionic, schizotypal, schizoid, or antisocial personality disorder.
  • The patient is currently on clozapine or received electroconvulsive therapy in the last 12 months.
  • The patient has a history of epilepsy or seizures, neuroleptic malignant syndrome,tardive dyskinesia, or other medical condition that would expose the patient to undue risk.
  • The patient has a positive serology for human immunodeficiency virus (HIV)-1, HIV-2,hepatitis B surface antigen, and/or hepatitis C.
  • The patient has current or history of known hypersensitivity to risperidone or any of the excipients of TV-46000 or the oral formulation of risperidone used in the stabilization phase.
  • The patient has a substance use disorder, including alcohol and benzodiazepines but excluding nicotine and caffeine.
  • The patient has previously participated in a Teva-sponsored clinical study with TV-46000.
  • The patient is a pregnant or lactating female.
  • The patient has any disorder that may interfere with drug absorption, distribution,metabolism, or excretion (including gastrointestinal surgery).
  • The patient has used an investigational drug within 3 months prior to screening or has participated in a non-drug clinical trial within 30 days prior to screening.
  • Additional criteria apply, please contact the investigator for more information

Locations

  • Teva Investigational Site 14818 not yet accepting patients
    San Diego California 92103 United States
  • Teva Investigational Site 14828 not yet accepting patients
    San Diego California 92103 United States
  • Teva Investigational Site 14771 accepting new patients
    National City California 91950 United States
  • Teva Investigational Site 14819 not yet accepting patients
    San Marcos California 92078 United States
  • Teva Investigational Site 14827 not yet accepting patients
    Oceanside California 92056 United States
  • Teva Investigational Site 14797 not yet accepting patients
    Oceanside California 92054 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Teva Branded Pharmaceutical Products, R&D Inc.
ID
NCT03503318
Phase
Phase 3
Study Type
Interventional
Last Updated
June 2, 2018