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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: BL - 1020
Drug: Placebo
Drug: Risperidone
Phase 2

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

Resource links provided by NLM:


Further study details as provided by BioLineRx, Ltd.:

Primary Outcome Measures:
  • to evaluate the safety and tolerability of two dose ranges [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to evaluate the efficacy of two dose ranges [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: July 2008
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
BL - 1020 lowdose
Drug: BL - 1020
10 mg/day
Other Name: BL - 1020
Experimental: II
BL 1020 high dose
Drug: BL - 1020
BL 1020 20-30 mg/day
Other Name: BL - 1020
Placebo Comparator: III Drug: Placebo
Capsules
Other Name: Placebo
Active Comparator: IV
Risperidone
Drug: Risperidone
Capsules
Other Name: Risperidone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00567710

Locations
United States, Texas
Mary ann Knisevich
Irving, Texas, United States, 75062
Sponsors and Collaborators
BioLineRx, Ltd.
Investigators
Study Director: Yona Geffen, Ph.D BioLineRx, Ltd.
  More Information

No publications provided by BioLineRx, Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BioLineRx, Drug development Company
ClinicalTrials.gov Identifier: NCT00567710     History of Changes
Other Study ID Numbers: BL - 1020 IIb, BL - 1020 IIb
Study First Received: December 4, 2007
Last Updated: June 27, 2010
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on July 23, 2014