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A Study to Evaluate the Safety, Tolerability, and Effect of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia
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.
Age
13 - 65 years
Sex
ALL
Healthy Volunteers
No
Teva Investigational Site 14391
Phoenix, Arizona, United States
Teva Investigational Site 14401
Scottsdale, Arizona, United States
Teva Investigational Site 14405
Tucson, Arizona, United States
Teva Investigational Site 14796
Rogers, Arkansas, United States
Teva Investigational Site 14811
Anaheim, California, United States
Teva Investigational Site 14794
Bellflower, California, United States
Teva Investigational Site 14776
Colton, California, United States
Teva Investigational Site 14802
Costa Mesa, California, United States
Teva Investigational Site 14773
Culver City, California, United States
Teva Investigational Site 14774
Glendale, California, United States
Start Date
April 17, 2019
Primary Completion Date
December 2, 2021
Completion Date
December 2, 2021
Last Updated
December 7, 2022
336
ACTUAL participants
TV-46000
DRUG
Placebo
DRUG
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
NCT07455929
NCT06740383
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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