Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020

Study Overview
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Brief Summary
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A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum Of Six Weeks With Bl-1020 (High Dose, Low Dose), Risperidone Or Placebo

Detailed Description
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This is a six-week, randomized, double blind, multi-center, parallel group Extension to the BL-1020 IIb study. In this Extension Study in patients hospitalized with schizophrenia who were previously treated in the BL-1020 IIb study with BL-1020 (low dose: 10 mg/day; high dose: target dose 30 mg/day), risperidone (target dose: 8 mg/day) or placebo after experiencing an acute exacerbation of schizophrenia. Patients who completed the 6 week treatment period and/or all efficacy assessments in Study BL-1020 IIb are eligible to continue double-blind treatment in this optional 6 week Extension Study. Approximately 220 patients will be enrolled in this study: Treatment Group IE (n=82, 10 mg/day BL-1020); Treatment Group IIE (n=82: target dose 30 mg/day BL-1020); Treatment Group IIIE (n=55; target dose 8 mg/day risperidone). Study drug (BL-1020 or risperidone) will be administered orally, once daily, in a doubleblinded manner, during this six-week Extension Study

Official Title
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A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: BL-1020
* Drug: BL-1020 10-30 mg
* Drug: risperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18-65 years of age at the time of entry into the BL-1020 IIb study Has provided informed consent to participate in the Extension Study Has completed 6 weeks of treatment and/or completed all efficacy assessments in Study BL-1020 IIb Females must have negative serum pregnancy test, or be post-menopausal, or if fecund, must practice established methods of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]) for at least two months prior to screening Females must use an established method of birth control (as above) AND a barrier method (condom, diaphragm, contraceptive foam) while taking study medication Has a caregiver or an identified responsible person (e.g., family member, social worker, nurse) who will support him/her to ensure compliance with the treatment and outpatient visits Is willing to comply with not taking any prohibited medications during participation in the study Successful completion of End of Study assessments from BL-1020 IIb Exclusion Criteria: Is unwilling or unable to provide informed consent Is unwilling or unable, in the opinion of the Investigator, to comply with study instructions Has a medical condition that would put him/her at risk for continuing in the study Score > 9 on Modified InterSePT Scale for Suicidal Thinking (Modified ISST) Tested positive for drugs of abuse during the initial 6 weeks of treatment (Study BL-1020 IIb) Has been non-compliant with the study medication dosing and/or study procedures during the initial 6 weeks of treatment in Study BL-1020 IIb Is judged by the PI to be inappropriate for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>BL-1020 10 mg | Drug: BL-1020<br>* 10 mg<br>|
| Experimental: 2<br>BL-1020 10-30 mg | Drug: BL-1020 10-30 mg<br>* BL-1020 10-30 mg<br>* Other names: BL-1020 High Dose;|
| Active Comparator: 3<br>risperidone | Drug: risperidone<br>* risperidone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes from baseline in vital signs, laboratory and ECG evaluations, physical/neurological examination, Extrapyramidal Symptom Rating Scale (ESRS), and incidence of adverse events (AEs) and adverse drop-outs (ADOs). |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparisons between each of the BL-1020 treatment groups and the risperidone group |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia