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

This study has been 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.)
Sponsor:
Information provided by (Responsible Party):
BioLineRx, Ltd.
ClinicalTrials.gov Identifier:
NCT01363349
First received: May 30, 2011
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Schizophrenia
Cognitive Effect on Schizophrenic Patients
Drug: CYP-1020
Drug: Risperidone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by BioLineRx, Ltd.:

Primary Outcome Measures:
  • Cognition [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Long Term Cognition [ Time Frame: 12 and 24 weeks of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluation of the antipsychotic efficacy of BL-1020 compared to risperidone after 6, 12 and 24 weeks of treatment


Enrollment: 269
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363349

Locations
India
Department of Psychiatry, Sheath VS General Hospital, Sheath KM School of Post Graduate Medicine & Research
Ahmedabad, India
Saoji Tupkari Hospital
Aurangabad, India
Spandana Nursing Home
Bangalore, India
KHM Hospital
Chennai, India
Department of Psychiatry, Owaisi Hospital & Research Centre
Hyderabad, India
Asha Hospital
Hyderabad, India
RK Yadav Memorial Mental Health and De-addiction Hospital
Jaipur, India
Mahendru Psychiatric Centre
Kanpur, India
Dreamland Nursing Home
Kolkata, India
Dayanand Medical College & Hospital
Ludhiana, India
Centre for Psychiatric Research, Department of Psychiatry, K.S Hegde Medical Academy
Mangalore, India
Jaslok Hospital&Research Centre
Mumbai, India
JSS Medical College Hospital
Mysore, India
Sujata Birla Hospital
Nashik, India
Vimhans Hospital
New Delhi, India
S.V.Medical College
Tirupati, India
Deva Mental Health Care
Varanasi, India
Vijayawada Institute of Mental Health & Neurosciences
Vijayawada, India
Moldova, Republic of
IMSP Spitalul Clinic de Psihiatrie, Sectia 14
Chisinau, Moldova, Republic of
IMSP Spitalul Clinic de Psihiatrie, Sectia 17
Chisinau, Moldova, Republic of
IMSP Spitalul Clinic de Psihiatrie, Sectia 8
Chisinau, Moldova, Republic of
Romania
pitalul Clinic Judetean de Urgenta Arad Clinica Psihiatrie
Arad, Romania
Spitalul de Psihiatrie si Neurologie Brasov
Brasov, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
Bucharest, Romania
Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 1
Bucharest, Romania
Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 13
Bucharest, Romania
Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 8
Bucharest, Romania
Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 9
Bucharest, Romania
Spitalul de Psihiatrie C.E.T.T.T. "Sf. Stelian"
Bucharest, Romania
Spitalul Judetean Cluj Napoca
Cluj Napoca, Romania
Spitalul Clinic Judetean de Urgenta Constanţa Clinica de Psihiatrie
Constanta, Romania
Spitalul Clinic de Neuropsihiatrie Clinica de Psihiatrie nr. 2
Craiova, Romania
Spitalul de Neuropsihiatrie Clinica de Psihiatrie I
Craiova, Romania
Spitalul Clinic de Psihiatrie Socola
Iasi, Romania
Spital Clinic de Neurologie si Psihiatrie Oradea
Oradea, Romania
Spitalul Clinic Municipal "Dr.Gavril Curteanu" Oradea
Oradea, Romania
Spitalul de Psihiatrie "Dr. Gh. Preda"
Sibiu, Romania
Spitalul Judetean de Urgenta Targoviste Clinica Psihiatrie Adulti nr. 7
Targoviste, Romania
Spitalul Clinic Judetean Mures, Clinica Psihiatrie Nr. 2
Targu-Mures, Romania
Sponsors and Collaborators
BioLineRx, Ltd.
Investigators
Study Chair: Arnon Aharon, MD BioLineRx, Ltd.
  More Information

No publications provided

Responsible Party: BioLineRx, Ltd.
ClinicalTrials.gov Identifier: NCT01363349     History of Changes
Obsolete Identifiers: NCT01365299
Other Study ID Numbers: 1020-CLIN-201
Study First Received: May 30, 2011
Results First Received: April 22, 2014
Last Updated: September 17, 2014
Health Authority: India: Drugs Controller General of India
Romania: National Medicines Agency
Moldova: Ministry of Health

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 24, 2014