Status:
COMPLETED
Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020
Lead Sponsor:
BioLineRx, Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 Schizophr...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00722176
Start Date
June 1 2008
End Date
December 1 2009
Last Update
June 29 2010
Active Locations (1)
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1
University of California, Irvine
Irvine, California, United States, 92868