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

Phase 1

• Conditions: Maintenance treatment of schizophrenia in patients currently treated with oral antipsychotics; MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2019-000063-24-BG
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-22
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

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

New Patients:
The patient has a diagnosis of schizophrenia according to the DSM-5 for >1 year (diagnosis must be reconfirmed by SCID-5) and =1 episode of relapse in the last 24 months.

please refer to the protocol for additional inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Roll Over and New patients:
The patient has a current clinically significant 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.

please refer to the protocol for additional exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000 administered in adult and adolescent patients with schizophrenia.;Secondary Objective: Not Applicable;Primary end point(s): The primary endpoint is the frequency of all adverse events, including serious adverse events.;Timepoint(s) of evaluation of this end point: All scheduled and any unscheduled visit of the study period

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable