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

This study has been terminated.
(pre-planned interim analysis of the Phase II/III CLARITY trial of BL-1020 indicate that the trial would not meet the pre-specified primary efficacy endpoint.)
Sponsor:
Information provided by (Responsible Party):
BioLineRx, Ltd.
ClinicalTrials.gov Identifier:
NCT01363349
First received: May 30, 2011
Last updated: September 17, 2014
Last verified: September 2014
Results First Received: April 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Schizophrenia
Cognitive Effect on Schizophrenic Patients
Interventions: Drug: CYP-1020
Drug: Risperidone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CYP-1020 CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
Risperidone

2-6 mg, 6 months

Risperidone


Participant Flow:   Overall Study
    CYP-1020     Risperidone  
STARTED     133     136  
Randomized     133     136  
COMPLETED     66     66  
NOT COMPLETED     67     70  
Adverse Event                 6                 7  
Lack of Efficacy                 3                 10  
Non compliance/Protocol deviations                 2                 2  
Withdrawal by Subject                 14                 6  
Lost to Follow-up                 5                 6  
Not reported                 36                 37  
missing                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CYP-1020 CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
Risperidone

2-6 mg, 6 months

Risperidone

Total Total of all reporting groups

Baseline Measures
    CYP-1020     Risperidone     Total  
Number of Participants  
[units: participants]
  133     136     269  
Age  
[units: years]
Mean ± Standard Deviation
  33.3  ± 8.76     32.3  ± 7.97     32.8  ± 8.37  
Gender  
[units: participants]
     
Female     49     49     98  
Male     84     87     171  
Race/Ethnicity, Customized  
[units: number¬†of¬†participants]
     
asian     92     94     186  
caucasian     41     42     83  
Region of Enrollment  
[units: participants]
     
Romania     41     42     83  
India     92     94     186  



  Outcome Measures

1.  Primary:   Cognition   [ Time Frame: Baseline and 6 weeks ]

2.  Secondary:   Long Term Cognition   [ Time Frame: 12 and 24 weeks of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Long Term Schizophrenia Treatment   [ Time Frame: Baseline and 6, 12 and 24 weeks of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Arnon Aharon
Organization: BioLineRx LTD
phone: 972-2-548-9100 ext 135
e-mail: arnona@biolinerx.com


No publications provided


Responsible Party: BioLineRx, Ltd.
ClinicalTrials.gov Identifier: NCT01363349     History of Changes
Obsolete Identifiers: NCT01365299
Other Study ID Numbers: 1020-CLIN-201
Study First Received: May 30, 2011
Results First Received: April 22, 2014
Last Updated: September 17, 2014
Health Authority: India: Drugs Controller General of India
Romania: National Medicines Agency
Moldova: Ministry of Health