Clinical trial NCT01363349: Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Cognitive Effect on Schizophrenic Patients
Lead sponsor: BioLineRx, Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-01
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Cognition
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Long Term Cognition
timeFrame: 12 and 24 weeks of treatment
measure: Long Term Schizophrenia Treatment
timeFrame: Baseline and 6, 12 and 24 weeks of treatment
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Department of Psychiatry, Sheath VS General Hospital, Sheath KM School of Post Graduate Medicine & Research
city: Aurangabad
country: India
facility: Saoji Tupkari Hospital
city: Bangalore
country: India
facility: Spandana Nursing Home
city: Chennai
country: India
facility: KHM Hospital
city: Hyderabad
country: India
facility: Asha Hospital
city: Hyderabad
country: India
facility: Department of Psychiatry, Owaisi Hospital & Research Centre
city: Jaipur
country: India
facility: RK Yadav Memorial Mental Health and De-addiction Hospital
city: Kanpur
country: India
facility: Mahendru Psychiatric Centre
city: Kolkata
country: India
facility: Dreamland Nursing Home
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
city: Mangalore
country: India
facility: Centre for Psychiatric Research, Department of Psychiatry, K.S Hegde Medical Academy
city: Mumbai
country: India
facility: Jaslok Hospital&Research Centre
city: Mysore
country: India
facility: JSS Medical College Hospital
city: Nashik
country: India
facility: Sujata Birla Hospital
city: New Delhi
country: India
facility: Vimhans Hospital
city: Tirupati
country: India
facility: S.V.Medical College
city: Varanasi
country: India
facility: Deva Mental Health Care
city: Vijayawada
country: India
facility: Vijayawada Institute of Mental Health & Neurosciences
city: Chisinau
country: Moldova, Republic of
facility: IMSP Spitalul Clinic de Psihiatrie, Sectia 14
city: Chisinau
country: Moldova, Republic of
facility: IMSP Spitalul Clinic de Psihiatrie, Sectia 17
city: Chisinau
country: Moldova, Republic of
facility: IMSP Spitalul Clinic de Psihiatrie, Sectia 8
city: Arad
country: Romania
facility: pitalul Clinic Judetean de Urgenta Arad Clinica Psihiatrie
city: Brasov
country: Romania
facility: Spitalul de Psihiatrie si Neurologie Brasov
city: Bucharest
country: Romania
facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
city: Bucharest
country: Romania
facility: Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 13
city: Bucharest
country: Romania
facility: Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 1
city: Bucharest
country: Romania
facility: Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 8
city: Bucharest
country: Romania
facility: Spitalul Clinic de Psihiatrie Dr. Alexandru Obregia Department 9
city: Bucharest
country: Romania
facility: Spitalul de Psihiatrie C.E.T.T.T. "Sf. Stelian"
city: Cluj Napoca
country: Romania
facility: Spitalul Judetean Cluj Napoca
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Constanţa Clinica de Psihiatrie
city: Craiova
country: Romania
facility: Spitalul Clinic de Neuropsihiatrie Clinica de Psihiatrie nr. 2
city: Craiova
country: Romania
facility: Spitalul de Neuropsihiatrie Clinica de Psihiatrie I
city: Iasi
country: Romania
facility: Spitalul Clinic de Psihiatrie Socola
city: Oradea
country: Romania
facility: Spital Clinic de Neurologie si Psihiatrie Oradea
city: Oradea
country: Romania
facility: Spitalul Clinic Municipal "Dr.Gavril Curteanu" Oradea
city: Sibiu
country: Romania
facility: Spitalul de Psihiatrie "Dr. Gh. Preda"
city: Targoviste
country: Romania
facility: Spitalul Judetean de Urgenta Targoviste Clinica Psihiatrie Adulti nr. 7
city: Targu-Mures
country: Romania
facility: Spitalul Clinic Judetean Mures, Clinica Psihiatrie Nr. 2
Study officials:
affiliation: BioLineRx, Ltd.
name: Arnon Aharon, MD
role: STUDY_CHAIR
References: