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

Schizophrenia Clinical Trial

— CLARITY  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01363349
• Other study ID #: 1020-CLIN-201
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: May 30, 2011
• Last updated: September 17, 2014
• Start date: May 2011
• Est. completion date: April 2013

Study information

• Verified date: September 2014
• Source: BioLineRx, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaRomania: National Medicines AgencyMoldova: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Other known NCT identifiers

• NCT01365299

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 269
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognitive Effect on Schizophrenic Patients
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
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	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
Moldova, Republic of	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
Romania	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 13	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 Constanta 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

Sponsors (1)

Lead Sponsor	Collaborator
BioLineRx, Ltd.

Countries where clinical trial is conducted

India,  Moldova, Republic of,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Long Term Cognition	Evaluation of the cognitive benefits of treatment with BL-1020 compared to risperidone after 12 and 24 weeks of treatment	12 and 24 weeks of treatment	No
Secondary	Long Term Schizophrenia Treatment	Evaluation of the antipsychotic efficacy of BL-1020 compared to risperidone after 6, 12 and 24 weeks of treatment	Baseline and 6, 12 and 24 weeks of treatment	No