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

This study has been completed.
Sponsor:
Information provided by:
BioLineRx, Ltd.
ClinicalTrials.gov Identifier:
NCT00480571
First received: May 30, 2007
Last updated: July 20, 2009
Last verified: August 2007

May 30, 2007
July 20, 2009
June 2007
December 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00480571 on ClinicalTrials.gov Archive Site
  • To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • To compare the efficacy of the two dose ranges of BL-1020 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • To determine the pharmacokinetics of BL-1020 and its metabolites [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose [ Time Frame: 6 weeks ]
  • To compare the efficacy of the two dose ranges of BL-1020 [ Time Frame: 6 weeks ]
  • To determine the pharmacokinetics of BL-1020 and its metabolites [ Time Frame: 6 weeks ]
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Drug: BL-1020
    BL-1020 Low Dose
  • Drug: BL 1020 High Dose
    BL 1020 High Dose
  • Experimental: 1
    BL 1020 low dose
    Intervention: Drug: BL-1020
  • Experimental: 2
    BL 1020 High Dose
    Intervention: Drug: BL 1020 High Dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2007
December 2007   (final data collection date for primary outcome measure)

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.).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel,   Romania
 
NCT00480571
BL-1020 II
Yes
BioLineRx, Drug Development Company
BioLineRx, Ltd.
Not Provided
Principal Investigator: Michael Davidson, MD Dept. of Psychiatry, Sheba Medical Center
BioLineRx, Ltd.
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP