NCT01363349

Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia

A Randomized, Double-Blind, Active-Controlled,Phase 2/3 Study to Determine the Short-Term (6-Week) and Long-Term (6 Month) Cognitive and Anti-Psychotic Efficacy, Safety and Tolerability of CYP-1020 Compared to Risperidone in Patients With Schizophrenia

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: BioLineRx, Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, active-controlled, 6 month study designed to evaluate the cognitive effects of treatment with CYP-1020 compared to risperidone. The primary efficacy endpoint will occur after 6 weeks of treatment; additional (secondary) efficacy endpoints will occur after 12 and 24 weeks of treatment. Up to 450 patients will be randomized to CYP-1020 or risperidone in a 1:1 ratio. The study will utilize a flexible dose escalation scheme designed to allow patients to titrate to their maximally tolerated dose; doses of CYP-1020 may range from a minimum of 15 mg to a maximum of 35 mg, whereas doses of risperidone will range from a minimum of 1 mg to 3 mg BID (2-6 mg daily). To ensure effective blinding across all treatment groups, all patients will be treated twice daily with study drug and/or placebo, as indicated (i.e., double-dummy design).

Conditions

• Schizophrenia
• Cognitive Effect on Schizophrenic Patients

Interventions

Type	Name	Description
DRUG	CYP-1020	CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
DRUG	Risperidone

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-03-01
• Completion: 2013-04-01
• First posted: 2011-06-01
• Last updated: 2014-09-18
• Results posted: 2014-09-18

Locations

39 sites across 3 countries: India, Moldova, Romania