A Phase 3 interventional study of TV-46000 and Placebo in Schizophrenia, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 90 sites in 5 countries. Open to participants aged 13 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 3, Interventional, and Treatment
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 participants, the total duration of participant 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 participants, the total duration of participant 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]). Participants 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. Participants 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, participants will be treated according to the investigator's judgment.
All participants will be treated with active drug.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 336 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072:
New Participants (Not Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072):
Exclusion Criteria:
Participants Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072:
New Participants (Not Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072) and Roll-Over Participants:
Participants will receive a subcutaneous (SC) injection of TV-46000 at baseline and every 4 weeks (q4w) thereafter for up to 56 weeks. The maximal dose administered to adult participants is comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents is comparable to 4 mg/day.
Drug: TV-46000
Participants will receive an SC injection of TV-46000 at baseline and every 8 weeks (q8w) thereafter, and a placebo SC injection 4 weeks after baseline and q8w thereafter for up to 56 weeks. The maximal dose administered to adult participants is comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents is comparable to 4 mg/day.
Drug: TV-46000 · Drug: Placebo
TV-46000 will be administered per dose and schedule specified in the arm description.
Also known as: Risperidone
Placebo matching to TV-46000 will be administered per schedule specified in the arm description.
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline up to Week 64
Number of Participants With SAEs
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. The safety analysis set included all participants who received at least 1 dose of TV46000 in TV-46000-CNS-30072 study or in TV46000-CNS-30078 study.
Time frame: Baseline up to Week 64
Number of Participants Who Were Withdrawn From the Treatment
The number of participants who were withdrawn from the treatment due to any reason has been reported. The safety analysis set included all participants who received at least 1 dose of TV46000 in TV-46000-CNS-30072 study or in TV46000-CNS-30078 study.
Time frame: Baseline up to Week 64
Participants who did not experience a relapse and completed Study TV46000-CNS-30072 (NCT03503318) (roll-over participants) and new participants entered this study. Open-label oral risperidone (at a dose of 2 to 5 milligrams \[mg\]/day, based on clinical judgment) for 12 weeks was given to stabilize new participants to the treatments before randomization.
| Milestone | TV-46000 q1m | TV-46000 q2m |
|---|---|---|
| Started | 174 | 162 |
| Received at least 1 dose of study drug | 172 | 162 |
| Completed | 135 | 122 |
| Not completed | 39 | 40 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Withdrawal by subject | 19 | 21 |
| Withdrew: Protocol deviation | 1 | 0 |
| Withdrew: Lost to follow-up | 10 | 10 |
| Withdrew: Other than specified | 7 | 6 |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | TV-46000 q1m | TV-46000 q2m |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 64 | 74 |
The number of participants who were withdrawn from the treatment due to any reason has been reported. The safety analysis set included all participants who received at least 1 dose of TV46000 in TV-46000-CNS-30072 study or in TV46000-CNS-30078 study.
| Participants | TV-46000 q1m | TV-46000 q2m |
|---|---|---|
| Death | 2 | 1 |
| Adverse event | 2 | 5 |
| Withdrawal by participant | 21 | 25 |
| Non-compliance with study drug | 1 | 0 |
| Protocol deviation | 2 | 1 |
| Lost-to-follow up | 5 | 7 |
| Lack of efficacy | 1 | 0 |
| Relapse | 3 | 3 |
| Other | 11 | 11 |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. The safety analysis set included all participants who received at least 1 dose of TV46000 in TV-46000-CNS-30072 study or in TV46000-CNS-30078 study.
| Participants | TV-46000 q1m | TV-46000 q2m |
|---|---|---|
| Number of Participants With SAEs | 8 | 11 |
Collected over Baseline up to Week 64. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TV-46000 q1m | 2/172 (1.2%) | 8/172 (4.7%) | 10/172 (5.8%) |
| TV-46000 q2m | 1/162 (0.6%) | 11/162 (6.8%) | 12/162 (7.4%) |
| Event | TV-46000 q1m | TV-46000 q2m |
|---|---|---|
| SchizophreniaPsychiatric disorders | 1/172 | 2/162 |
| AnaemiaBlood and lymphatic system disorders | 0/172 | 1/162 |
| Acute myocardial infarctionCardiac disorders | 0/172 | 1/162 |
| Angina pectorisCardiac disorders | 0/172 | 1/162 |
| HyperglycaemiaMetabolism and nutrition disorders | 1/172 | 1/162 |
| DepressionPsychiatric disorders | 0/172 | 1/162 |
| Panic attackPsychiatric disorders | 0/172 | 1/162 |
| Psychotic disorderPsychiatric disorders | 0/172 | 1/162 |
| Self-injurious ideationPsychiatric disorders | 0/172 | 1/162 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/172 | 1/162 |
| Event | TV-46000 q1m | TV-46000 q2m |
|---|---|---|
| Injection site noduleGeneral disorders | 3/172 | 9/162 |
| Injection site painGeneral disorders | 9/172 | 7/162 |
The intent-to-treat (ITT) analysis set included all randomized participants who were randomized either in Study TV46000-CNS-30072 for roll-over participants or in Study TV46000-CNS-30078.
| Age, Continuous(years) | TV-46000 q1m | TV-46000 q2m | Total |
|---|---|---|---|
| Mean | 51.3 ± 10.28 | 49.8 ± 11.51 | 50.6 ± 10.90 |
| Sex: Female, Male(Participants) | TV-46000 q1m | TV-46000 q2m | Total |
|---|---|---|---|
| Female | 61 | 59 | 120 |
| Male | 113 | 103 | 216 |
| Ethnicity (NIH/OMB)(Participants) | TV-46000 q1m | TV-46000 q2m | Total |
|---|---|---|---|
| Hispanic or Latino | 56 | 51 | 107 |
| Not Hispanic or Latino | 118 | 110 | 228 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race/Ethnicity, Customized(Participants) | TV-46000 q1m | TV-46000 q2m | Total |
|---|---|---|---|
| Race — White | 80 | 67 | 147 |
| Race — Black or African American | 91 | 90 | 181 |
| Race — Asian | 1 | 2 | 3 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Race — Not reported | 1 | 1 | 2 |
| Race — Other | 1 | 1 | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request
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Teva Branded Pharmaceutical Products R&D, Inc.