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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 30, 2007

Last Updated Date

July 20, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00480571 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Schizophrenia
Schizoaffective Disorder

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
BL 1020 low dose

Intervention: Drug: BL-1020
Experimental: 2
BL 1020 High Dose

Intervention: Drug: BL 1020 High Dose

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.).

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel, Romania

Administrative Information

NCT Number ^ICMJE

NCT00480571

Other Study ID Numbers ^ICMJE

BL-1020 II

Has Data Monitoring Committee

Yes

Responsible Party

BioLineRx, Drug Development Company

Study Sponsor ^ICMJE

BioLineRx, Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael Davidson, MD

Dept. of Psychiatry, Sheba Medical Center

Information Provided By

BioLineRx, Ltd.

Verification Date

August 2007

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

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