Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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. 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
Information provided by (Responsible Party):
BioLineRx, Ltd.

Brief 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).

Condition or disease Intervention/treatment Phase
Schizophrenia Cognitive Effect on Schizophrenic Patients Drug: CYP-1020 Drug: Risperidone Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: CYP-1020
Dose titration 15-35mg/day for 6 months
Drug: CYP-1020
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
Drug: Risperidone

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or non-pregnant or lactating female, 18-50 years of age inclusive
  2. Patients must have exhibited symptoms meeting the criteria of schizophrenia for at least one year, but not more than 20 years, prior to Screening
  3. Recent onset (not more than 30 days) of worsening of psychiatric symptoms at Screening.
  4. Currently experiencing an acute exacerbation of schizophrenia, as defined by the following results at Screening and Baseline:

    • ≥70 total score on the PANSS
    • ≥4 (moderate) on two of the following four PANSS items: (1) delusions, (2) hallucinatory behaviors, (3) conceptual disorganization or (4) suspiciousness/persecution, where at least one of the two items must be either delusions or hallucinatory behaviors
  5. CGI-S score between 4 and 6 (moderately ill to severely ill) at the Screening and Baseline visits.
  6. Has exhibited a sufficient clinical response to at least one previous course of an anti-psychotic agent prescribed at a generally recognized therapeutic dose.
  7. Must have completed at least 5 years of formal education or its equivalent

Exclusion Criteria:

  1. Breastfeeding or pregnant
  2. Symptoms of schizophrenia for more than 20 years at the time of screening.
  3. Psychotic symptoms that have failed to improve (based on Investigator's opinion or documented medical history) following sufficient treatment with therapeutic doses of two or more anti-psychotics agents over the preceding 2 years
  4. Prior history of neuroleptic malignant syndrome
  5. Prior history or current evidence of moderate or severe tardive dyskinesia (mild is acceptable).
  6. Abnormal ECG evaluation
  7. History of confirmed epilepsy or prior seizure disorder (history of a single febrile seizure is not exclusionary)
  8. In the opinion of the investigator, unstable medical disease (e.g., malignancy, poorly controlled diabetes or hypertension, ischemic cardiac disease, dilated cardiomyopathy or valvular heart disease, pulmonary disease, liver disease, kidney disease)
  9. Acute infectious disease (e.g., malaria, dengue fever, hepatitis A), or chronic infectious disease (e.g., history of AIDS or HIV positivity, tuberculosis)
  10. Likely allergy, sensitivity or intolerance to BL-1020, perphenazine, risperidone, paliperidone, or any of the drug product excipients
  11. Any suicide attempt within the preceding 2 years
  12. Any Substance Dependence disorder
  13. High likelihood of substance abuse
  14. Diagnosis with one of the following DSM-IV-TR Axis I diagnoses: schizophreniform disorder, schizoaffective disorder, bipolar disorder, substance dependency, mood disorder with psychotic features; psychotic disorder NOS
  15. Requiring chronic treatment with benzodiazepines
  16. Requiring chronic treatment with mood stabilizers
  17. Previously treated with clozapine within 6 months prior to screening
  18. Any abnormal clinical laboratory test result that is judged by the Investigator to be clinically significant
  19. History of, or serologic evidence of, acute or chronic active hepatitis B or C

Information from the National Library of Medicine

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 identifier (NCT number): NCT01363349

Show Show 39 study locations
Sponsors and Collaborators
BioLineRx, Ltd.
Layout table for investigator information
Study Chair: Arnon Aharon, MD BioLineRx, Ltd.
Layout table for additonal information
Responsible Party: BioLineRx, Ltd. Identifier: NCT01363349    
Obsolete Identifiers: NCT01365299
Other Study ID Numbers: 1020-CLIN-201
First Posted: June 1, 2011    Key Record Dates
Results First Posted: September 18, 2014
Last Update Posted: September 18, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents