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

BioLineRx, Ltd.2 sites in 2 countries90 target enrollmentJune 2007

ConditionsSchizophrenia Schizoaffective Disorder

InterventionsBL-1020 BL 1020 High Dose

DrugsBL-1020 BL 1020 High Dose

Overview

Phase: Phase 2
Intervention: BL-1020
Conditions: Schizophrenia
Sponsor: BioLineRx, Ltd.
Enrollment: 90
Locations: 2
Primary Endpoint: 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
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

December 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

BioLineRx, Ltd.

Eligibility Criteria

Inclusion Criteria

•Male or female
•18 to 65 years of age, inclusive
•meet criteria for chronic (diagnosis established \> 1 year ago) schizophrenia with adequate psychotic symptoms as demonstrated by a PANSS total score \> 60
•current diagnosis of schizophrenia (disorganized type, 295.10; catatonic type, 295.20; paranoid type, 295.30; undifferentiated type, 295.90) or schizoaffective disorder (295.7) in accordance with DSM-IV
•Agree to be fully hospitalized until at least Day 14 of the study
•Females must be of non-childbearing potential: surgically sterilized (i.e. tubal ligation), have had a hysterectomy prior to the screening phase, or be post-menopausal. Females who have been post-menopausal for more than 12 months but less than 24 months must have a FSH \> 40 mU/mL.

Exclusion Criteria

•Pregnant or lactating women
•administration of clozapine within 60 days prior to Baseline
•DSM-IV diagnosis of schizophreniform disorder (295.40) or schizophrenia residual sub-type (295.60), or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder
•Severity of psychosis rated severe or higher (CGI-S 6 or 7)
•Known suicidal risk (modified ISST score\>7)
•Requiring disallowed concomitant psychotropic medication following enrolment into the study
•Current evidence of clinically significant or unstable illness
•Clinically significant abnormal laboratory data (e.g. creatinine, AST or ALT greater than 3 x the upper limit of normal, TSH\>10 IU) at screening, or any abnormal laboratory values that could interfere with the assessment of safety (e.g. blood cell count, etc.).

Arms & Interventions

1

BL 1020 low dose

Intervention: BL-1020

2

BL 1020 High Dose

Intervention: BL 1020 High Dose

Outcomes

Primary Outcomes

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

Time Frame: 6 weeks

Secondary Outcomes

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)
To determine the pharmacokinetics of BL-1020 and its metabolites(6 weeks)