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Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BL-1020

BL-1020 10-30 mg

risperidone

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, 18-65 years of age at the time of entry into the BL-1020 IIb study
Has provided informed consent to participate in the Extension Study
Has completed 6 weeks of treatment and/or completed all efficacy assessments in Study BL-1020 IIb
Females must have negative serum pregnancy test, or be post-menopausal, or if fecund, must practice established methods of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]) for at least two months prior to screening
Females must use an established method of birth control (as above) AND a barrier method (condom, diaphragm, contraceptive foam) while taking study medication
Has a caregiver or an identified responsible person (e.g., family member, social worker, nurse) who will support him/her to ensure compliance with the treatment and outpatient visits
Is willing to comply with not taking any prohibited medications during participation in the study
Successful completion of End of Study assessments from BL-1020 IIb

Exclusion Criteria:

Is unwilling or unable to provide informed consent
Is unwilling or unable, in the opinion of the Investigator, to comply with study instructions
Has a medical condition that would put him/her at risk for continuing in the study
Score > 9 on Modified InterSePT Scale for Suicidal Thinking (Modified ISST)
Tested positive for drugs of abuse during the initial 6 weeks of treatment (Study BL-1020 IIb)
Has been non-compliant with the study medication dosing and/or study procedures during the initial 6 weeks of treatment in Study BL-1020 IIb
Is judged by the PI to be inappropriate for the study

Sites / Locations

University of California, Irvine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

BL-1020 10 mg

BL-1020 10-30 mg

risperidone

Outcomes

Primary Outcome Measures

changes from baseline in vital signs, laboratory and ECG evaluations, physical/neurological examination, Extrapyramidal Symptom Rating Scale (ESRS), and incidence of adverse events (AEs) and adverse drop-outs (ADOs).

Secondary Outcome Measures

Comparisons between each of the BL-1020 treatment groups and the risperidone group

Full Information

NCT ID

NCT00722176

First Posted

July 23, 2008

Last Updated

June 27, 2010

Sponsor

BioLineRx, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00722176

Brief Title

Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020

Official Title

A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

BioLineRx, Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum Of Six Weeks With Bl-1020 (High Dose, Low Dose), Risperidone Or Placebo

Detailed Description

This is a six-week, randomized, double blind, multi-center, parallel group Extension to the BL-1020 IIb study. In this Extension Study in patients hospitalized with schizophrenia who were previously treated in the BL-1020 IIb study with BL-1020 (low dose: 10 mg/day; high dose: target dose 30 mg/day), risperidone (target dose: 8 mg/day) or placebo after experiencing an acute exacerbation of schizophrenia. Patients who completed the 6 week treatment period and/or all efficacy assessments in Study BL-1020 IIb are eligible to continue double-blind treatment in this optional 6 week Extension Study. Approximately 220 patients will be enrolled in this study: Treatment Group IE (n=82, 10 mg/day BL-1020); Treatment Group IIE (n=82: target dose 30 mg/day BL-1020); Treatment Group IIIE (n=55; target dose 8 mg/day risperidone). Study drug (BL-1020 or risperidone) will be administered orally, once daily, in a doubleblinded manner, during this six-week Extension Study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

BL-1020 10 mg

Arm Title

Arm Type

Experimental

Arm Description

BL-1020 10-30 mg

Arm Title

Arm Type

Active Comparator

Arm Description

risperidone

Intervention Type

Drug

Intervention Name(s)

BL-1020

Intervention Description

10 mg

Intervention Type

Drug

Intervention Name(s)

BL-1020 10-30 mg

Other Intervention Name(s)

BL-1020 High Dose

Intervention Description

BL-1020 10-30 mg

Intervention Type

Drug

Intervention Name(s)

risperidone

Intervention Description

risperidone

Primary Outcome Measure Information:

Title

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Comparisons between each of the BL-1020 treatment groups and the risperidone group

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, 18-65 years of age at the time of entry into the BL-1020 IIb study Has provided informed consent to participate in the Extension Study Has completed 6 weeks of treatment and/or completed all efficacy assessments in Study BL-1020 IIb Females must have negative serum pregnancy test, or be post-menopausal, or if fecund, must practice established methods of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]) for at least two months prior to screening Females must use an established method of birth control (as above) AND a barrier method (condom, diaphragm, contraceptive foam) while taking study medication Has a caregiver or an identified responsible person (e.g., family member, social worker, nurse) who will support him/her to ensure compliance with the treatment and outpatient visits Is willing to comply with not taking any prohibited medications during participation in the study Successful completion of End of Study assessments from BL-1020 IIb Exclusion Criteria: Is unwilling or unable to provide informed consent Is unwilling or unable, in the opinion of the Investigator, to comply with study instructions Has a medical condition that would put him/her at risk for continuing in the study Score > 9 on Modified InterSePT Scale for Suicidal Thinking (Modified ISST) Tested positive for drugs of abuse during the initial 6 weeks of treatment (Study BL-1020 IIb) Has been non-compliant with the study medication dosing and/or study procedures during the initial 6 weeks of treatment in Study BL-1020 IIb Is judged by the PI to be inappropriate for the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Ann Knisevich, MD

Organizational Affiliation

University Hills Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Irvine

City

Irvine

State/Province

California

ZIP/Postal Code

92868

Country

United States

12. IPD Sharing Statement

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Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020

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