A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study

This study has been completed.
Sponsor:
Information provided by:
BioLineRx, Ltd.
ClinicalTrials.gov Identifier:
NCT00567710
First received: December 4, 2007
Last updated: June 27, 2010
Last verified: June 2010

December 4, 2007
June 27, 2010
July 2008
July 2009   (final data collection date for primary outcome measure)
to evaluate the safety and tolerability of two dose ranges [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00567710 on ClinicalTrials.gov Archive Site
to evaluate the efficacy of two dose ranges [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: BL - 1020
    10 mg/day
    Other Name: BL - 1020
  • Drug: BL - 1020
    BL 1020 20-30 mg/day
    Other Name: BL - 1020
  • Drug: Placebo
    Capsules
    Other Name: Placebo
  • Drug: Risperidone
    Capsules
    Other Name: Risperidone
  • Experimental: I
    BL - 1020 lowdose
    Intervention: Drug: BL - 1020
  • Experimental: II
    BL 1020 high dose
    Intervention: Drug: BL - 1020
  • Placebo Comparator: III
    Intervention: Drug: Placebo
  • Active Comparator: IV
    Risperidone
    Intervention: Drug: Risperidone
Geffen Y, Keefe R, Rabinowitz J, Anand R, Davidson M. Bl-1020, a new γ-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
September 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00567710
BL - 1020 IIb, BL - 1020 IIb
No
BioLineRx, Drug development Company
BioLineRx, Ltd.
Not Provided
Study Director: Yona Geffen, Ph.D BioLineRx, Ltd.
BioLineRx, Ltd.
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP