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| ID | Type | Description | Link |
|---|---|---|---|
| BL - 1020 IIb |
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This is a prospective, six-week, randomized, double blind, placebo-controlled, multi-center study in patients with schizophrenia who are experiencing an acute exacerbation of psychosis.
This study consists of a 5- to 14-day screening period to include antipsychotic medication washout, followed by a six-week double blind treatment period. Patients completing the 6-week treatment period may continue double-blind treatment in an optional extension period of at least 6 weeks' duration. Patients randomized to placebo during the initial 6-week period will be randomized to BL-1020 low or high dose during the extension treatment period. Approximately 40 study centers in four countries will participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | BL - 1020 lowdose |
|
| II | Experimental | BL 1020 high dose |
|
| III | Placebo Comparator |
| |
| IV | Active Comparator | Risperidone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL - 1020 | Drug | 10 mg/day |
| |
| BL - 1020 |
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the safety and tolerability of two dose ranges | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the efficacy of two dose ranges | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
General
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| Name | Affiliation | Role |
|---|---|---|
| Yona Geffen, Ph.D | BioLineRx, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mary ann Knisevich | Irving | Texas | 75062 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23059159 | Derived | Geffen Y, Keefe R, Rabinowitz J, Anand R, Davidson M. Bl-1020, a new gamma-aminobutyric acid-enhanced antipsychotic: results of 6-week, randomized, double-blind, controlled, efficacy and safety study. J Clin Psychiatry. 2012 Sep;73(9):e1168-74. doi: 10.4088/JCP.12m07642. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 27, 2011 | |
| Reset | May 23, 2011 | |
| Release | Jun 3, 2011 | |
| Unrelease | Yes | |
| Release | Jun 6, 2011 | |
| Reset | Jun 22, 2011 | |
| Release | Feb 2, 2012 | |
| Reset | Mar 5, 2012 | |
| Release | Aug 16, 2017 | |
| Unrelease | Yes | |
| Release | Aug 17, 2017 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 27, 2011 | May 23, 2011 | |||
| Jun 3, 2011 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C539977 | perphenazine GABA ester |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
BL 1020 20-30 mg/day |
|
| Placebo | Drug | Capsules |
|
| Risperidone | Drug | Capsules |
|
| Yes |
| Jun 6, 2011 | Jun 22, 2011 |
| Feb 2, 2012 | Mar 5, 2012 |
| Aug 16, 2017 | Yes |
| Aug 17, 2017 | Yes |