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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01363349
• Date of registration: 30/05/2011
• Prospective Registration: No
• Primary sponsor: BioLineRx, Ltd.
• Public title: Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia CLARITY
• Scientific 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
• Date of first enrolment: May 2011
• Target sample size: 269
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01363349
• Study type: Interventional
• Phase: Phase 2/Phase 3

Countries of recruitment

India, Moldova, Republic of, Romania

Contacts

• Name: Arnon Aharon, MD
• Affiliation: BioLineRx, Ltd.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cognitive Effect on Schizophrenic Patients

Schizophrenia

Intervention(s)

Drug: Risperidone

Drug: CYP-1020

Primary Outcome(s)

Cognition [Time Frame: Baseline and 6 weeks]

Secondary Outcome(s)

Long Term Cognition [Time Frame: 12 and 24 weeks of treatment]

Long Term Schizophrenia Treatment [Time Frame: Baseline and 6, 12 and 24 weeks of treatment]

Secondary ID(s)

1020-CLIN-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/09/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01363349