Official Title: “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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

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

Intervention(s) in this Clinical Trial

• Drug: BL-1020
  • 10 mg
• Drug: BL-1020 10-30 mg
  • BL-1020 10-30 mg
• Drug: risperidone
  • risperidone

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • BL-1020 10 mg
• Experimental: 2
  • BL-1020 10-30 mg
• Active Comparator: 3
  • risperidone

Primary Measures

• 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).
  • Time Frame: 6 weeks
    Safety Issue?: Yes

Secondary Measures

• Comparisons between each of the BL-1020 treatment groups and the risperidone group
  • Time Frame: 6 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: BioLineRx, Ltd.

Overall Clinical Trial Officials and Contacts

Mary Ann Knisevich, MD Principal Investigator University Hills Clinical Research  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00722176

Study ID Number: BL-1020 IIb (Extension)

ClinicalTrials.gov Identifier: NCT00722176

Health Authority: United States: Food and Drug Administration