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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480571
• Other study ID #: BL-1020 II
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2007
• Last updated: July 20, 2009
• Start date: June 2007
• Est. completion date: December 2007

Study information

• Verified date: August 2007
• Source: BioLineRx, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mood Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• BL-1020
BL-1020 Low Dose
• BL 1020 High Dose
BL 1020 High Dose

Locations

Country	Name	City	State
Israel	Dept. of Psychiatry, Sheba Medical Center	Tel Hashomer
Romania	Spitalul Clinic de Urgenta Militar Central "Dr Carol Davila",	Bucharest	Str Mircea Vulcanescu 18

Sponsors (1)

Lead Sponsor	Collaborator
BioLineRx, Ltd.

Countries where clinical trial is conducted

Israel,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose		6 weeks	Yes
Secondary	To compare the efficacy of the two dose ranges of BL-1020		6 weeks	No
Secondary	To determine the pharmacokinetics of BL-1020 and its metabolites		6 weeks	No