Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia (CLARITY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363349
|Study Chair:||Arnon Aharon, MD||BioLineRx, Ltd.|