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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | BL 1020 low dose |
|
| 2 | Experimental | BL 1020 High Dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL-1020 | Drug | BL-1020 Low Dose |
| |
| BL 1020 High Dose |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of two dose ranges (20-40 mg/day, 30-50 mg/day) of BL-1020 tri-mesylate (free base) in subjects with chronic schizophrenia or schizo-affective disorder | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose | 6 weeks | |
| To compare the efficacy of the two dose ranges of BL-1020 | 6 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Davidson, MD | Dept. of Psychiatry, Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Psychiatry, Sheba Medical Center | Tel Litwinsky | Israel | ||||
| Spitalul Clinic de Urgenţǎ Militar Central "Dr Carol Davila", |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C539977 | perphenazine GABA ester |
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| Drug |
BL 1020 High Dose |
|
| To determine the pharmacokinetics of BL-1020 and its metabolites |
| 6 weeks |
| Bucharest |
| Str Mircea Vulcǎnescu 18 |
| 010811 |
| Romania |