Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder

Phase 2

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: BL-1020; Drug: BL 1020 High Dose

• Registration Number: NCT00480571
• Lead Sponsor: BioLineRx, Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-30
• Study First Posted: 2007-05-31
• Study Start: 2007-06
• Status Verified: 2007-08
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Last Update Submitted: 2009-07-20
• Last Update Posted: 2009-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	BL-1020	BL 1020 low dose
2	BL 1020 High Dose	BL 1020 High Dose

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Spitalul Clinic de Urgenţǎ Militar Central "Dr Carol Davila",; 🇷🇴 Bucharest, Str Mircea Vulcǎnescu 18, Romania

Dept. of Psychiatry, Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel