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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
  Purpose

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


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: BL-1020
Drug: BL 1020 High Dose
Phase 2

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

Resource links provided by NLM:


Further study details as provided by BioLineRx, Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: June 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480571

Locations
Israel
Dept. of Psychiatry, Sheba Medical Center
Tel Hashomer, Israel
Romania
Spitalul Clinic de Urgenţǎ Militar Central "Dr Carol Davila",
Bucharest, Str Mircea Vulcǎnescu 18, Romania, 010811
Sponsors and Collaborators
BioLineRx, Ltd.
Investigators
Principal Investigator: Michael Davidson, MD Dept. of Psychiatry, Sheba Medical Center
  More Information

No publications provided

Responsible Party: BioLineRx, Drug Development Company
ClinicalTrials.gov Identifier: NCT00480571     History of Changes
Other Study ID Numbers: BL-1020 II
Study First Received: May 30, 2007
Last Updated: July 20, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by BioLineRx, Ltd.:
chronic schizophrenia or schizo-affective disorder

Additional relevant MeSH terms:
Disease
Mood Disorders
Psychotic Disorders
Schizophrenia
Mental Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 24, 2014