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

This study has been completed.
Sponsor:
Information provided by:
BioLineRx, Ltd.
ClinicalTrials.gov Identifier:
NCT00722176
First received: July 23, 2008
Last updated: June 27, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: BL-1020
Drug: BL-1020 10-30 mg
Drug: risperidone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by BioLineRx, Ltd.:

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). [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparisons between each of the BL-1020 treatment groups and the risperidone group [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
BL-1020 10 mg
Drug: BL-1020
10 mg
Other Name: BL-1020
Experimental: 2
BL-1020 10-30 mg
Drug: BL-1020 10-30 mg
BL-1020 10-30 mg
Other Name: BL-1020 High Dose
Active Comparator: 3
risperidone
Drug: risperidone
risperidone
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00722176

Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92868
Sponsors and Collaborators
BioLineRx, Ltd.
Investigators
Principal Investigator: Mary Ann Knisevich, MD University Hills Clinical Research
  More Information

No publications provided

Responsible Party: BioLineRx
ClinicalTrials.gov Identifier: NCT00722176     History of Changes
Other Study ID Numbers: BL-1020 IIb (Extension)
Study First Received: July 23, 2008
Last Updated: June 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by BioLineRx, Ltd.:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014