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:

1. Male or female, 18-65 years of age at the time of entry into the BL-1020 IIb study

2. Has provided informed consent to participate in the Extension Study

3. Has completed 6 weeks of treatment and/or completed all efficacy assessments in Study
BL-1020 IIb

4. 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

5. Females must use an established method of birth control (as above) AND a barrier
method (condom, diaphragm, contraceptive foam) while taking study medication

6. 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

7. Is willing to comply with not taking any prohibited medications during participation
in the study

8. Successful completion of End of Study assessments from BL-1020 IIb

Exclusion Criteria:

1. Is unwilling or unable to provide informed consent

2. Is unwilling or unable, in the opinion of the Investigator, to comply with study
instructions

3. Has a medical condition that would put him/her at risk for continuing in the study

4. Score > 9 on Modified InterSePT Scale for Suicidal Thinking (Modified ISST)

5. Tested positive for drugs of abuse during the initial 6 weeks of treatment (Study
BL-1020 IIb)

6. 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

7. Is judged by the PI to be inappropriate for the study