A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BL - 1020
BL - 1020
Placebo
Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Patient is male or female, 18-65 years of age, inclusive.
- If female, the patient must be post-menopausal, or if fecund, must be abstinent or practicing an established method of birth control such as hormonal preparations (e.g., oral contraceptive tablets, hormonal implant device, hormone patch, or injectable contraceptive), or intrauterine device [IUD], for at least two months prior to screening, and in addition must use a barrier method, e.g., condom, diaphragm, contraceptive foam.
- Patient is willing and able to provide informed consent, after the nature of the study has been fully explained.
- Patient is an inpatient or outpatient who has a current DSM-IV-TR diagnosis of schizophrenia, as confirmed by the MINI-Plus.
- Patient must be experiencing an acute exacerbation of psychosis, with a baseline (Study Day 0) total score on the PANSS greater than '70'.
- Patient must have a score of '4' ("moderate") or more at baseline on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/persecution, where at least one of the two items must be either delusions or hallucinatory behaviors, and the total score on the four items must be greater than '17'.
- Patient must be experiencing an acute exacerbation of psychosis with a total score on the CGI-S of '4' ("moderate") or greater at baseline.
- Patient is willing to be hospitalized at screening, and willing to remain in the hospital at least 14 days after baseline (through Study Day 14) as clinically indicated, and must be willing to comply with all study related evaluations and procedures through Study Day 42.
- Patient 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.
- Patient is willing to comply with not taking any prohibited medications during participation in the study.
Exclusion Criteria:
- The presence of any of the following will exclude a patient from study enrolment:
General
- Patient is unwilling or unable to provide informed consent.
- Patient is unwilling or unable, in the opinion of the Investigator, to comply with study instructions.
- If female, patient is pregnant, breast-feeding, has a positive urine pregnancy test at screening or baseline, or is of reproductive capacity and is unwilling to comply with accepted contraceptive methods during the study, ie, not using an oral contraceptive, hormonal patch or implant, injectable contraceptive or IUD, in combination with a barrier method (see Inclusion Criterion #2).
- Patient has made a plasma or blood donation within 14 days prior to the screening visit.
- Patient has participated in a prior clinical study of BL-1020 or any of its excipients, and/or has received an investigational drug within thirty days prior to screening.
- Patient is judged by the PI to be inappropriate for the study.
Sites / Locations
- Mary ann Knisevich
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
I
II
III
IV
Arm Description
BL - 1020 lowdose
BL 1020 high dose
Risperidone
Outcomes
Primary Outcome Measures
to evaluate the safety and tolerability of two dose ranges
Secondary Outcome Measures
to evaluate the efficacy of two dose ranges
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00567710
Brief Title
A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study
Official Title
A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study to Determine the Efficacy, Tolerability and Safety of Low and High Non-overlapping Dose Ranges of BL-1020 Compared to Placebo and Risperidone
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
BioLineRx, Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, six-week, randomized, double blind, placebo-controlled, multi-center study in patients with schizophrenia who are experiencing an acute exacerbation of psychosis.
Detailed Description
This study consists of a 5- to 14-day screening period to include antipsychotic medication washout, followed by a six-week double blind treatment period. Patients completing the 6-week treatment period may continue double-blind treatment in an optional extension period of at least 6 weeks' duration. Patients randomized to placebo during the initial 6-week period will be randomized to BL-1020 low or high dose during the extension treatment period. Approximately 40 study centers in four countries will participate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Arm Description
BL - 1020 lowdose
Arm Title
II
Arm Type
Experimental
Arm Description
BL 1020 high dose
Arm Title
III
Arm Type
Placebo Comparator
Arm Title
IV
Arm Type
Active Comparator
Arm Description
Risperidone
Intervention Type
Drug
Intervention Name(s)
BL - 1020
Intervention Description
10 mg/day
Intervention Type
Drug
Intervention Name(s)
BL - 1020
Intervention Description
BL 1020 20-30 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Capsules
Primary Outcome Measure Information:
Title
to evaluate the safety and tolerability of two dose ranges
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
to evaluate the efficacy of two dose ranges
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
No
Eligibility Criteria
Inclusion Criteria:
Patient is male or female, 18-65 years of age, inclusive.
If female, the patient must be post-menopausal, or if fecund, must be abstinent or practicing an established method of birth control such as hormonal preparations (e.g., oral contraceptive tablets, hormonal implant device, hormone patch, or injectable contraceptive), or intrauterine device [IUD], for at least two months prior to screening, and in addition must use a barrier method, e.g., condom, diaphragm, contraceptive foam.
Patient is willing and able to provide informed consent, after the nature of the study has been fully explained.
Patient is an inpatient or outpatient who has a current DSM-IV-TR diagnosis of schizophrenia, as confirmed by the MINI-Plus.
Patient must be experiencing an acute exacerbation of psychosis, with a baseline (Study Day 0) total score on the PANSS greater than '70'.
Patient must have a score of '4' ("moderate") or more at baseline on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/persecution, where at least one of the two items must be either delusions or hallucinatory behaviors, and the total score on the four items must be greater than '17'.
Patient must be experiencing an acute exacerbation of psychosis with a total score on the CGI-S of '4' ("moderate") or greater at baseline.
Patient is willing to be hospitalized at screening, and willing to remain in the hospital at least 14 days after baseline (through Study Day 14) as clinically indicated, and must be willing to comply with all study related evaluations and procedures through Study Day 42.
Patient 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.
Patient is willing to comply with not taking any prohibited medications during participation in the study.
Exclusion Criteria:
The presence of any of the following will exclude a patient from study enrolment:
General
Patient is unwilling or unable to provide informed consent.
Patient is unwilling or unable, in the opinion of the Investigator, to comply with study instructions.
If female, patient is pregnant, breast-feeding, has a positive urine pregnancy test at screening or baseline, or is of reproductive capacity and is unwilling to comply with accepted contraceptive methods during the study, ie, not using an oral contraceptive, hormonal patch or implant, injectable contraceptive or IUD, in combination with a barrier method (see Inclusion Criterion #2).
Patient has made a plasma or blood donation within 14 days prior to the screening visit.
Patient has participated in a prior clinical study of BL-1020 or any of its excipients, and/or has received an investigational drug within thirty days prior to screening.
Patient is judged by the PI to be inappropriate for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yona Geffen, Ph.D
Organizational Affiliation
BioLineRx, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Mary ann Knisevich
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23059159
Citation
Geffen Y, Keefe R, Rabinowitz J, Anand R, Davidson M. Bl-1020, a new gamma-aminobutyric acid-enhanced antipsychotic: results of 6-week, randomized, double-blind, controlled, efficacy and safety study. J Clin Psychiatry. 2012 Sep;73(9):e1168-74. doi: 10.4088/JCP.12m07642.
Results Reference
derived
Learn more about this trial
A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study
We'll reach out to this number within 24 hrs