Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia (CLARITY)
|ClinicalTrials.gov Identifier: NCT01363349|
Recruitment Status : Terminated (pre-planned interim analysis of the Phase II/III CLARITY trial of BL-1020 indicate that the trial would not meet the pre-specified primary efficacy endpoint.)
First Posted : June 1, 2011
Results First Posted : September 18, 2014
Last Update Posted : September 18, 2014
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).
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Cognitive Effect on Schizophrenic Patients||Drug: CYP-1020 Drug: Risperidone||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||269 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||April 2013|
Dose titration 15-35mg/day for 6 months
CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
Other Name: BL-1020
Active Comparator: Risperidone
Dose titration 2-6mg/day for 6 months
- Cognition [ Time Frame: Baseline and 6 weeks ]To evaluate the cognitive benefits of treatment with CYP-1020 (formerly known as BL-1020) compared to risperidone after 6 weeks of treatment in patients experiencing acute exacerbation of schizophrenia. Assessed by calculating difference between CYP-1020 and Risperidone on mean change from baseline to Week 6 endpoint on MATRICS Consensus Cognition Battery (MCCB) normative composite score. MCCB is a neuropsychological test battery that comprises 10 measures of 7 different cognitive areas including speed of processing, verbal learning, memory-verbal and non verbal reasoning and problem solving, visual learning, social cognition, attention/vigilance.The study was terminated after the interim analysis. MCBB total score ranges from -50 to 150. Change from Baseline by Visit (LOCF)Higher score means better cognitive functioning.
- Long Term Cognition [ Time Frame: 12 and 24 weeks of treatment ]Evaluation of the cognitive benefits of treatment with BL-1020 compared to risperidone after 12 and 24 weeks of treatment
- Long Term Schizophrenia Treatment [ Time Frame: Baseline and 6, 12 and 24 weeks of treatment ]Evaluation of the antipsychotic efficacy of BL-1020 compared to risperidone after 6, 12 and 24 weeks of treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363349
|Study Chair:||Arnon Aharon, MD||BioLineRx, Ltd.|