Clinical trial NCT01363349 (phase 2/phase 3, status: terminated)
Conditions: schizophrenia, cognitive effect on schizophrenic patients
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9
Drugs: cyp-1020, risperidone
SMILES: OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12
Reason stopped: 
    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.
  
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