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

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

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