A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia

• Status: Active, not recruiting
• Trial end date: 2021-12-14
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse events, including serious adverse events. For new patients, the total duration of patient participation in the study is planned to be up to 80 weeks (including a screening period of up to 4 weeks, a 12-week oral conversion/stabilization stage [Stage 1], a 56-week double-blind maintenance stage [Stage 2], and a follow-up period [8 weeks]). For roll-over patients, the total duration of patient participation in the study is planned to be up to 64 weeks (including up to 56 weeks in the maintenance stage [Stage 2] and a follow-up period [8 weeks]). Patients who started Stage 2 who relapse or meet 1 or more of the withdrawal criteria should be invited to perform the Early Termination visit as soon as possible within 4 weeks of the last injection. Patients who withdraw from the study before completing the 56-week maintenance stage will have follow-up procedures and assessments performed at their follow-up visits. During the follow-up period, patients will be treated according to the investigator's judgment.

All subjects will be treated with active drug.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.

Criteria

Inclusion Criteria:

Patients Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072:

• The patient must have participated in the pivotal efficacy study (Study TV46000-CNS-30072) without experiencing relapse events and without important protocol deviations.

• If the patient was taking antidepressants or mood stabilizers in Study TV46000-CNS-30072, no dose changes or initiation of treatment with these medications will be permitted.

• The patient, in the investigator's judgment, requires chronic treatment with an antipsychotic medication.

• The patient is able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens (oral and sc administration) and non-use of prohibited concomitant medications; can read and understand the written word in order to complete patient-reported outcomes measures; and can be reliably rated on assessment scales.

• The patient has had a stable place of residence for the previous 3 months before the baseline visit in this study, and changes in residence are not anticipated over the course of study participation.

• The patient has no significant life events (such as pending loss of housing, family status change, long travel abroad, surgery, etc) that could affect study outcomes expected throughout the period of study participation.

• Women of childbearing potential and sexually active female adolescents 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 drug and for the duration of the study and for 120 days after the last injection of study drug.

• The patient, if adult or adolescent male, is surgically sterile, or, if capable of producing offspring, 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. In addition, male patients may not donate sperm for the duration of the study and for 120 days after taking the study drug.

New Patients (Not Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072):

• The patient has a diagnosis of schizophrenia

• The patient has been responsive to an antipsychotic treatment (other than clozapine) in the past year based on investigator judgment (and discussions with family members, caregivers, or healthcare professionals as applicable).

• The patient, in the investigator's judgment, requires chronic treatment with an antipsychotic medication.

• The patient is able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens (oral and sc administration) and non-use of prohibited concomitant medications; can read and understand the written word in order to complete patient-reported outcomes measures; and can be reliably rated on assessment scales.

• The patient has had 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 (such as pending loss of housing, family status change, long travel abroad, surgery, etc) that could affect study outcomes expected throughout the period of study participation.

• The patient has a body mass index between 18.0 and 38.0 kg/m2, inclusive.

• Women of childbearing potential and sexually active female adolescents 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 drug and for the duration of the study and for 120 days after the last injection of study drug.

• The patient, if adult or adolescent male, is surgically sterile, or, if capable of producing offspring, 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. In addition, male patients may not donate sperm for the duration of the study and for 120 days after taking the study drug.

• Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

Patients Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072:

• The patient has a finding in the baseline 12-lead ECG that is considered clinically significant in the judgment of the investigator.

• Poor compliance with study procedures (in the opinion of the investigator or sponsor) during the pivotal efficacy Study TV46000-CNS-30072. This should be discussed on a case-by-case basis.

New Patients (Not Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072) and Roll-Over Patients:

• The patient is currently on clozapine or has 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 a 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 is a pregnant or lactating female.

• The patient has used an investigational drug other than TV-46000 within 3 months prior to screening or has participated in a non-drug clinical trial within 30 days prior to screening.

• Vulnerable patients (eg, people kept in detention).

• Additional criteria apply, please contact the investigator for more information.