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

Completed · Phase 2

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT00722176

Run by

BioLineRx, Ltd.

People needed

220

Starts

2008-06-01

Expected to finish

2009-12-01

Last updated by the study team

2010-06-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Irvine — Irvine, California, United States

Full record on ClinicalTrials.gov

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