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

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: BL-1020; Drug: BL-1020 10-30 mg; Drug: risperidone

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

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92868
      • University of California, Irvine

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:

1. Male or female, 18-65 years of age at the time of entry into the BL-1020 IIb study
2. Has provided informed consent to participate in the Extension Study
3. Has completed 6 weeks of treatment and/or completed all efficacy assessments in Study BL-1020 IIb
4. 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
5. Females must use an established method of birth control (as above) AND a barrier method (condom, diaphragm, contraceptive foam) while taking study medication
6. 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
7. Is willing to comply with not taking any prohibited medications during participation in the study
8. Successful completion of End of Study assessments from BL-1020 IIb

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; BL-1020 10 mg	Drug: BL-1020; 10 mg
EXPERIMENTAL: 2; BL-1020 10-30 mg	Drug: BL-1020 10-30 mg; BL-1020 10-30 mg; Other Names: BL-1020 High Dose
ACTIVE_COMPARATOR: 3; risperidone	Drug: risperidone; risperidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparisons between each of the BL-1020 treatment groups and the risperidone group	6 weeks

Collaborators and Investigators

• Sponsor: BioLineRx, Ltd.
• Investigators: Principal Investigator: Mary Ann Knisevich, MD, University Hills Clinical Research

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: July 23, 2008
• First Submitted That Met QC Criteria: July 24, 2008
• First Posted (ESTIMATE): July 25, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 29, 2010
• Last Update Submitted That Met QC Criteria: June 27, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: BL-1020 IIb (Extension)