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

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: BL-1020; Drug: BL 1020 High Dose

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Tel Hashomer, Israel
    • Dept. of Psychiatry, Sheba Medical Center
• Romania
  • Str Mircea Vulcǎnescu 18
    • Bucharest, Str Mircea Vulcǎnescu 18, Romania, 010811
      • Spitalul Clinic de Urgenţǎ Militar Central "Dr Carol Davila",

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; BL 1020 low dose	Drug: BL-1020; BL-1020 Low Dose
Experimental: 2; BL 1020 High Dose	Drug: BL 1020 High Dose; BL 1020 High Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
To determine the pharmacokinetics of BL-1020 and its metabolites	6 weeks

Collaborators and Investigators

• Sponsor: BioLineRx, Ltd.
• Investigators: Principal Investigator: Michael Davidson, MD, Dept. of Psychiatry, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: May 30, 2007
• First Submitted That Met QC Criteria: May 30, 2007
• First Posted (Estimate): May 31, 2007

Study Record Updates

• Last Update Posted (Estimate): July 21, 2009
• Last Update Submitted That Met QC Criteria: July 20, 2009
• Last Verified: August 1, 2007

More Information

Terms related to this study

• Keywords: chronic schizophrenia or schizo-affective disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Mood Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; GABA Agents; Perphenazine; gamma-Aminobutyric Acid
• Other Study ID Numbers: BL-1020 II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No