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

NCT01363349 | Terminated Phase 2 Results

• 1 other identifier: 1020-CLIN-201
• Study Type: interventional
• Target: 269
• Locations: 3 countries
• Sites: 39

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).

Conditions

Schizophrenia; Cognitive Effect on Schizophrenic Patients

Outcome Measures

Primary Outcomes (1)

• Cognition

  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.

  Baseline and 6 weeks

Secondary Outcomes (2)

• Long Term Cognition

  12 and 24 weeks of treatment

• Long Term Schizophrenia Treatment

  Baseline and 6, 12 and 24 weeks of treatment

Study Arms (2)

CYP-1020

EXPERIMENTAL

Dose titration 15-35mg/day for 6 months

Drug: CYP-1020

Risperidone

ACTIVE COMPARATOR

Dose titration 2-6mg/day for 6 months

Drug: Risperidone

Interventions

CYP-1020 DRUG

CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.

Also known as: BL-1020

CYP-1020

Risperidone DRUG

Risperidone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or non-pregnant or lactating female, 18-50 years of age inclusive
• Patients must have exhibited symptoms meeting the criteria of schizophrenia for at least one year, but not more than 20 years, prior to Screening
• Recent onset (not more than 30 days) of worsening of psychiatric symptoms at Screening.
• 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
• CGI-S score between 4 and 6 (moderately ill to severely ill) at the Screening and Baseline visits.
• Has exhibited a sufficient clinical response to at least one previous course of an anti-psychotic agent prescribed at a generally recognized therapeutic dose.
• Must have completed at least 5 years of formal education or its equivalent

You may not qualify if:

• Breastfeeding or pregnant
• Symptoms of schizophrenia for more than 20 years at the time of screening.
• 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
• Prior history of neuroleptic malignant syndrome
• Prior history or current evidence of moderate or severe tardive dyskinesia (mild is acceptable).
• Abnormal ECG evaluation
• 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)
• Acute infectious disease (e.g., malaria, dengue fever, hepatitis A), or chronic infectious disease (e.g., history of AIDS or HIV positivity, tuberculosis)
• Likely allergy, sensitivity or intolerance to BL-1020, perphenazine, risperidone, paliperidone, or any of the drug product excipients
• Any suicide attempt within the preceding 2 years
• Any Substance Dependence disorder
• High likelihood of substance abuse
• 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
• Requiring chronic treatment with benzodiazepines
• Requiring chronic treatment with mood stabilizers

Sponsors & Collaborators

• BioLineRx, Ltd.: lead

Study Sites (39)

Department of Psychiatry, Sheath VS General Hospital, Sheath KM School of Post Graduate Medicine & Research

Ahmedabad, India

Location

Saoji Tupkari Hospital

Aurangabad, India

Location

Spandana Nursing Home

Bangalore, India

Location

KHM Hospital

Chennai, India

Location

Asha Hospital

Hyderabad, India

Location

Department of Psychiatry, Owaisi Hospital & Research Centre

Hyderabad, India

Location

RK Yadav Memorial Mental Health and De-addiction Hospital

Jaipur, India

Location

Mahendru Psychiatric Centre

Kanpur, India

Location

Dreamland Nursing Home

Kolkata, India

Location

Dayanand Medical College & Hospital

Ludhiana, India

Location

Centre for Psychiatric Research, Department of Psychiatry, K.S Hegde Medical Academy

Mangalore, India

Location

Jaslok Hospital&Research Centre

Mumbai, India

Location

JSS Medical College Hospital

Mysore, India

Location

Sujata Birla Hospital

Nashik, India

Location

Vimhans Hospital

New Delhi, India

Location

S.V.Medical College

Tirupati, India

Location

Deva Mental Health Care

Varanasi, India

Location

Vijayawada Institute of Mental Health & Neurosciences

Vijayawada, India

Location

IMSP Spitalul Clinic de Psihiatrie, Sectia 14

Chisinau, Moldova

Location

IMSP Spitalul Clinic de Psihiatrie, Sectia 17

Chisinau, Moldova

Location

IMSP Spitalul Clinic de Psihiatrie, Sectia 8

Chisinau, Moldova

Location

pitalul Clinic Judetean de Urgenta Arad Clinica Psihiatrie

Arad, Romania

Location

Spitalul de Psihiatrie si Neurologie Brasov

Brasov, Romania

Location

Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"

Bucharest, Romania

Location

Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 13

Bucharest, Romania

Location

Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 1

Bucharest, Romania

Location

Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 8

Bucharest, Romania

Location

Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 9

Bucharest, Romania

Location

Spitalul de Psihiatrie C.E.T.T.T. "Sf. Stelian"

Bucharest, Romania

Location

Spitalul Judetean Cluj Napoca

Cluj-Napoca, Romania

Location

Spitalul Clinic Judetean de Urgenta Constanţa Clinica de Psihiatrie

Constanța, Romania

Location

Spitalul Clinic de Neuropsihiatrie Clinica de Psihiatrie nr. 2

Craiova, Romania

Location

Spitalul de Neuropsihiatrie Clinica de Psihiatrie I

Craiova, Romania

Location

Spitalul Clinic de Psihiatrie Socola

Iași, Romania

Location

Spital Clinic de Neurologie si Psihiatrie Oradea

Oradea, Romania

Location

Spitalul Clinic Municipal "Dr.Gavril Curteanu" Oradea

Oradea, Romania

Location

Spitalul de Psihiatrie "Dr. Gh. Preda"

Sibiu, Romania

Location

Spitalul Judetean de Urgenta Targoviste Clinica Psihiatrie Adulti nr. 7

Târgovişte, Romania

Location

Spitalul Clinic Judetean Mures, Clinica Psihiatrie Nr. 2

Târgu Mureş, Romania

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

perphenazine GABA ester; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Arnon Aharon
• Organization: BioLineRx LTD

arnona@biolinerx.com

972-2-548-9100

Study Officials

• Arnon Aharon, MD

  BioLineRx, Ltd.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 1, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 18, 2014
• Results First Posted: September 18, 2014

Record last verified: 2014-09

Locations

MO (3); RO (18); IN (18)