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

NCT00567710 | Completed Phase 2

• 1 other identifier: BL - 1020 IIb
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• to evaluate the safety and tolerability of two dose ranges

  6 weeks

Secondary Outcomes (1)

• to evaluate the efficacy of two dose ranges

  6 weeks

Study Arms (4)

I

EXPERIMENTAL

BL - 1020 lowdose

Drug: BL - 1020

II

EXPERIMENTAL

BL 1020 high dose

Drug: BL - 1020

III

PLACEBO COMPARATOR

Drug: Placebo

IV

ACTIVE COMPARATOR

Risperidone

Drug: Risperidone

Interventions

BL - 1020 DRUG

10 mg/day

I

Placebo DRUG

Capsules

III

Risperidone DRUG

Capsules

IV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BioLineRx, Ltd.: lead

Study Sites (1)

Mary ann Knisevich

Irving, Texas, 75062, United States

Location

Related Publications (1)

• 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.

  PMID: 23059159 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

perphenazine GABA ester; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yona Geffen, Ph.D

  BioLineRx, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 5, 2007
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

US (1)