Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia (RISE)
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|ClinicalTrials.gov Identifier: NCT03503318|
Recruitment Status : Active, not recruiting
First Posted : April 19, 2018
Last Update Posted : July 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: TV-46000 - A Drug: TV-46000 - B Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||863 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia|
|Actual Study Start Date :||April 27, 2018|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||October 31, 2020|
Experimental: TV-46000 - A
Dose regimen A
Drug: TV-46000 - A
Other Name: Risperidone
Experimental: TV-46000 - B
Dose regimen B
Drug: TV-46000 - B
Other Name: Risperidone
Placebo Comparator: Placebo
- Time to Impending Relapse [ Time Frame: 15 months ]Will be calculated as the earliest date the patient meets ≥1 of the impending relapse criteria
- Time to impending relapse [ Time Frame: 15 months ]As defined under the primary objective in the total population (adults and adolescents).
- Time to impending relapse in adolescent patients with schizophrenia [ Time Frame: 15 months ]This assessment is pending randomization of at least 10 adolescent patients with clinically sufficient exposure.
- Impending Relapse Rate [ Time Frame: Week 24 ]This rate will be estimated using the Kaplan-Meier method.
- Observed Rate of Impending Relapse [ Time Frame: 15 months ]Calculated as the number of patients who relapsed by endpoint divided by the number of patients in each treatment group.
- Percentage of Patients Who Maintain Stability [ Time Frame: 15 months ]Stability is defined as meeting all of the following criteria for at least 4 consecutive weeks: outpatient status; PANSS total score ≤80; minimal presence of specific psychotic symptoms on the PANSS, as measured by a score of ≤4 on each of the following items: conceptual disorganization, suspiciousness, hallucinatory behavior, and unusual thought content; Clinical Global Impression of Severity (CGI-S) score ≤4 (moderately ill); and Clinical Global Impression-Severity of Suicidality (CGI-SS) score ≤2 (mildly suicidal) on Part 1 and ≤5 (minimally worsened) on Part 2. The percentage will be calculated as the number of patients who maintained stability at endpoint divided by the number of patients in the given treatment group.
- Percentage of Patients Achieving Remission [ Time Frame: 15 months ]Positive symptom, negative symptom, and overall symptom remission will be examined and are defined by Andreasen et al (2005), including severity and duration criteria. All remission criteria can be derived from PANSS items.
- Percentage of Participants with Adverse Events [ Time Frame: 15 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503318
|Study Director:||Teva Medical Expert, MD||Teva Pharmaceuticals USA|