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Sponsored by: |
BioLineRx, Ltd. |
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Information provided by: | BioLineRx, Ltd. |
ClinicalTrials.gov Identifier: | NCT00480571 |
An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder
Condition | Intervention | Phase |
---|---|---|
Schizophrenia Schizoaffective Disorder |
Drug: BL-1020 Drug: BL 1020 High Dose |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Multi-Center, 6-Week, Sequential Cohort Study Designed to Determine the Safety and Tolerability of Two Dose Ranges of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder |
Estimated Enrollment: | 90 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2007 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
BL 1020 low dose
|
Drug: BL-1020
BL-1020 Low Dose
|
2: Experimental
BL 1020 High Dose
|
Drug: BL 1020 High Dose
BL 1020 High Dose
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Dept. of Psychiatry, Sheba Medical Center | |
Tel Hashomer, Israel | |
Romania, Str Mircea Vulcǎnescu 18 | |
Spitalul Clinic de Urgenţǎ Militar Central "Dr Carol Davila", | |
Bucharest, Str Mircea Vulcǎnescu 18, Romania, 010811 |
Principal Investigator: | Michael Davidson, MD | Dept. of Psychiatry, Sheba Medical Center |
Responsible Party: | Drug Development Company ( BioLineRx ) |
Study ID Numbers: | BL-1020 II |
Study First Received: | May 30, 2007 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00480571 |
Health Authority: | Israel: Ministry of Health |
chronic schizophrenia or schizo-affective disorder |
Schizophrenia Mental Disorders Mood Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Pathologic Processes Disease |