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

NCT ID: NCT00722176

Last Updated: 2010-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-12-31

Brief Summary

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

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

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

BL-1020 10 mg

Group Type: EXPERIMENTAL

BL-1020

Intervention Type: DRUG

10 mg

2

BL-1020 10-30 mg

Group Type: EXPERIMENTAL

BL-1020 10-30 mg

Intervention Type: DRUG

BL-1020 10-30 mg

3

risperidone

Group Type: ACTIVE_COMPARATOR

risperidone

Intervention Type: DRUG

risperidone

Interventions

BL-1020

10 mg

Intervention Type: DRUG

BL-1020 10-30 mg

BL-1020 10-30 mg

Intervention Type: DRUG

risperidone

risperidone

Intervention Type: DRUG

Other Intervention Names

BL-1020 High Dose

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioLineRx, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

BioLineRx

Principal Investigators

Mary Ann Knisevich, MD

Role: PRINCIPAL_INVESTIGATOR

University Hills Clinical Research

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

Other Identifiers

BL-1020 IIb (Extension)

Identifier Type: -

Identifier Source: org_study_id