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Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia

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Condition(s):
Schizophrenia
Status:
Completed
Requirements:
18 Years to 64 Years
Interventions:
Drug: TV-44749
Learn more The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.

Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia

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Condition(s):
Schizophrenia
Status:
Completed
Requirements:
18 Years to 64 Years
Interventions:
Drug: TV-44749
Learn more The primary objective is to evaluate the safety and tolerability of single doses of TV-44749 for subcutaneous (sc) use in Chinese participants with schizophrenia.

Study of TV-46000 for Maintenance Treatment of Schizophrenia

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Condition(s):
Schizophrenia
Status:
Completed
Requirements:
13 Years to 65 Years
Interventions:
Drug: TV-46000 | Drug: Placebo
Learn more Primary objectives: 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 Female, Male 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.Female, Male subjects will be treated with active drug.

Study to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia

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Condition(s):
Schizophrenia
Status:
Completed
Requirements:
Adult
Interventions:
Drug: TV-44749 | Drug: Placebo
Learn more The primary objective of this study is to evaluate the efficacy of TV-44749 in adult patients with schizophrenia. A key secondary objective is to further evaluate the efficacy of TV-44749 based on additional parameters in adult patients with schizophrenia. A secondary objective is to evaluate the safety and tolerability of TV-44749 in adult patients with schizophrenia. Another secondary objective of this study is to evaluate the efficacy of TV-44749 from baseline to endpoint in Period 1 in adult patients with schizophrenia. Total study duration is up to 61 weeks, and treatment duration is up to 56 weeks, with weekly visits during the first 8 weeks and then monthly in-clinic visits with weekly calls during the remainder of the treatment period. Participation requirements include: Having been diagnosed with schizophrenia for at least 1 year Experiencing a worsening of your schizophrenia within the last 8 weeks Please see complete requirements via inclusion and exclusion criteria link

Study to Evaluate TV-46000 as Maintenance Treatment in Participants With Schizophrenia

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Condition(s):
Schizophrenia
Status:
Completed
Requirements:
13 Years to 65 Years
Interventions:
Drug: TV-46000 - A | Drug: TV-46000 - B | Drug: Placebo
Learn more Please refer to ClinicalTrials.gov for a description of the trial