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Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

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

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

NCT01363349•BioLineRx, Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Locations (39)

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

Asha Hospital

Hyderabad, India

Department of Psychiatry, Owaisi Hospital & Research Centre

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

Key Dates

Start Date

May 1, 2011

Primary Completion Date

March 1, 2013

Completion Date

April 1, 2013

Last Updated

September 18, 2014

Enrollment

269

ACTUAL participants

Conditions

SchizophreniaCognitive Effect on Schizophrenic Patients

Interventions

CYP-1020

DRUG

Risperidone

DRUG

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Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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