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

NCT ID: NCT01363349

Last Updated: 2014-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CYP-1020

Dose titration 15-35mg/day for 6 months

Group Type: EXPERIMENTAL

CYP-1020

Intervention Type: DRUG

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

Risperidone

Dose titration 2-6mg/day for 6 months

Group Type: ACTIVE_COMPARATOR

Risperidone

Intervention Type: DRUG

Interventions

CYP-1020

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

Intervention Type: DRUG

Risperidone

Intervention Type: DRUG

Other Intervention Names

BL-1020

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioLineRx, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnon Aharon, MD

Role: STUDY_CHAIR

BioLineRx, Ltd.

Locations

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

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

IMSP Spitalul Clinic de Psihiatrie, Sectia 14

Chisinau, , Moldova

IMSP Spitalul Clinic de Psihiatrie, Sectia 17

Chisinau, , Moldova

IMSP Spitalul Clinic de Psihiatrie, Sectia 8

Chisinau, , Moldova

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 13

Bucharest, , Romania

Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 1

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

Constanța, , 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

Iași, , 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

Târgovişte, , Romania

Spitalul Clinic Judetean Mures, Clinica Psihiatrie Nr. 2

Târgu Mureş, , Romania

Countries

India; Moldova; Romania

Other Identifiers

1020-CLIN-201

Identifier Type: -

Identifier Source: org_study_id

NCT01365299

Identifier Type: -

Identifier Source: nct_alias