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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioLineRx, Ltd.
• Treatments: Risperidone

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