Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia
- Conditions
- Cognitive Effect on Schizophrenic PatientsSchizophrenia
- Interventions
- Registration Number
- NCT01363349
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 269
-
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.
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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
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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.
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Must have completed at least 5 years of formal education or its equivalent
- 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
- History of confirmed epilepsy or prior seizure disorder (history of a single febrile seizure is not exclusionary)
- 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
- Previously treated with clozapine within 6 months prior to screening
- Any abnormal clinical laboratory test result that is judged by the Investigator to be clinically significant
- History of, or serologic evidence of, acute or chronic active hepatitis B or C
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risperidone Risperidone Dose titration 2-6mg/day for 6 months CYP-1020 CYP-1020 Dose titration 15-35mg/day for 6 months
- Primary Outcome Measures
Name Time Method Cognition 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
Name Time Method Long Term Schizophrenia Treatment 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
Long Term Cognition 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
Trial Locations
- Locations (39)
RK Yadav Memorial Mental Health and De-addiction Hospital
🇮🇳Jaipur, India
Deva Mental Health Care
🇮🇳Varanasi, India
S.V.Medical College
🇮🇳Tirupati, India
Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 13
🇷🇴Bucharest, Romania
Dreamland Nursing Home
🇮🇳Kolkata, India
Mahendru Psychiatric Centre
🇮🇳Kanpur, 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
Asha Hospital
🇮🇳Hyderabad, India
Department of Psychiatry, Owaisi Hospital & Research Centre
🇮🇳Hyderabad, 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
Vijayawada Institute of Mental Health & Neurosciences
🇮🇳Vijayawada, India
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
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 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