NCT00567710

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: BioLineRx, Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	BL - 1020	10 mg/day
DRUG	BL - 1020	BL 1020 20-30 mg/day
DRUG	Placebo	Capsules
DRUG	Risperidone	Capsules

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2007-12-05
• Last updated: 2010-06-29

Locations

1 site across 1 country: United States