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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00722176
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : June 29, 2010
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: BL-1020 Drug: BL-1020 10-30 mg Drug: risperidone Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2008
Primary Completion Date : July 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources

Arms and Interventions

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 Name: BL-1020 High Dose
Active Comparator: 3
risperidone
Drug: risperidone
risperidone


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Comparisons between each of the BL-1020 treatment groups and the risperidone group [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: BioLineRx
ClinicalTrials.gov Identifier: NCT00722176     History of Changes
Other Study ID Numbers: BL-1020 IIb (Extension)
First Posted: July 25, 2008    Key Record Dates
Last Update Posted: June 29, 2010
Last Verified: June 2010

Keywords provided by BioLineRx, Ltd.:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents