Phase 3
Completed N=544
Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia
Source: ClinicalTrials.gov NCT03503318 ↗Enrolled (actual)
544
Serious AEs
5.9%
Results posted
Dec 2021
Primary outcomePrimary: Time to Impending Relapse (Number of Participants With Impending Relapse) for Intent-to-treat [ITT] Analysis Set — 53; 13; 23 Participants — p=<0.0001
◆ Published Evidence
Established
30citations · ~10 / year
Efficacy and safety of TV-46000, a long-acting, subcutaneous, injectable formulation of risperidone, for schizophrenia: a randomised clinical trial in the USA and Bulgaria.
Summary
The purpose of the study is to evaluate the efficacy, safety, and tolerability of different dose regimens of TV-46000 administered subcutaneously (SC) as compared to placebo during maintenance treatment in adult and adolescent participants with schizophrenia. The study will include male and female participants, 13 to 65 years of age, who have a confirmed diagnosis of schizophrenia, are clinically stable, and are eligible for risperidone treatment
Linked Publications (3)
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Efficacy and safety of TV-46000, a long-acting, subcutaneous, injectable formulation of risperidone, for schizophrenia: a randomised clinical trial in the USA and Bulgaria.
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Safety Outcomes with the Long-Acting Subcutaneous Antipsychotic TV-46000 in Schizophrenia: A Post Hoc Analysis of Behavioral, Neuromotor, Endocrine, and Cardiometabolic Outcomes from Two Phase 3 Studies.
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Effects of Long-Term Treatment with TV-46000 on Symptom Improvement Over Time in Stabilized Patients with Schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Impending Relapse (Number of Participants With Impending Relapse) for Intent-to-treat [ITT] Analysis Set |
53; 13; 23 | <0.0001 sig |
| SECONDARY Time to Impending Relapse (Number of Participants With Impending Relapse) for Extended ITT [eITT] Analysis Set |
53; 13; 24 | — |
| SECONDARY Proportion of Participants With Impending Relapse |
0.28; 0.07; 0.11 | — |
| SECONDARY Number of Participants Who Maintain Stability at the Endpoint |
110; 159; 143 | — |
| SECONDARY Number of Participants Achieving Remission at the Endpoint |
30; 39; 42 | — |
| SECONDARY Observed Rate of Impending Relapse (Number of Participants With Impending Relapse) at the Endpoint |
53; 13; 23 | — |
| SECONDARY Time to Impending Relapse (Number of Participants With Impending Relapse) in the Adolescent Participants |
1 | — |
| SECONDARY Change From Baseline in Drug Attitudes Inventory 10-item Version (DAI-10) Total Score at the Endpoint and End of Treatment |
6.1; 5.8; 5.7; -0.8; 0.1; -0.3 | — |
| SECONDARY Change From Baseline in Schizophrenia Quality of Life Scale (SQLS) Total Score at the Endpoint and End of Treatment |
34.0; 33.1; 34.2; 0.9; -4.5; -4.1 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
92; 111; 121 | — |
| SECONDARY Change From Baseline in Total Abnormal Involuntary Movement Scale (AIMS) Score at the End of Treatment |
0.4; 0.5; 0.2; 0.0; 0.1; 0.1 | — |
| SECONDARY Change From Baseline in Simpson-Angus Scale (SAS) Mean Score at the End of Treatment |
0.07; 0.09; 0.06; 0.04; 0.02; 0.00 | — |
| SECONDARY Change From Baseline in Total Barnes Akathisia Rating Scale (BARS) Score at the End of Treatment |
0.2; 0.1; 0.2; -0.1; 0.0; -0.1 | — |
| SECONDARY Number of Participants Reporting Suicidal Behavior and Suicidal Ideation Using Columbia-Suicide Severity Rating Scale (C-SSRS) at Baseline and Post-Baseline |
0; 0; 3; 6; 5; 7 | — |
| SECONDARY Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score at the End of Treatment |
1.6; 1.3; 1.5; -0.4; -0.3; -0.8 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity of Suicidality (CGI-SS) Score at the End of Treatment |
1.0; 1.0; 1.0; 4.0; 4.0; 4.0 | — |
| SECONDARY Plasma Concentration of Risperidone, 9-OH-risperidone, and Total Active Moiety (Sum of Risperidone and 9-OH-risperidone) |
4.694; 6.452; 5.364; 1.323; 13.215; 8.838 | — |
Eligibility Criteria
Inclusion Criteria
- The participant has a diagnosis of schizophrenia for >1 year and has had ≥1 episode of relapse in the last 24 months.
- The participant has been responsive to an antipsychotic treatment (other than clozapine) in the past year based on discussions with family members or healthcare professionals.
- The participant 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 participant has no significant life events 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 drugs and for the duration of the study and for 120 days after the last injection of study drug.
- The participant, if adult or adolescent 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 participants 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
Exclusion Criteria
- The participant 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 participant is currently on clozapine or received electroconvulsive therapy in the last 12 months.
- The participant has a history of epilepsy or seizures, neuroleptic malignant syndrome, tardive dyskinesia, or other medical condition that would expose the participant to undue risk.
- The participant has a positive serology for human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B surface antigen, and/or hepatitis C.
- The participant 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 participant has a substance use disorder, including alcohol and benzodiazepines but excluding nicotine and caffeine.
- The participant has previously participated in a Teva-sponsored clinical study with TV-46000.
- The participant is a pregnant or lactating female.
- The participant has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- The participant 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
Data sourced from ClinicalTrials.gov (NCT03503318) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.