Clinical trial NCT00567710 (phase 2, status: completed)
Conditions: schizophrenia
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9
Drugs: bl - 1020, bl - 1020, placebo, risperidone
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12
Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female, 18-65 years of age, inclusive.

          -  If female, the patient must be post-menopausal, or if fecund, must be abstinent or
             practicing an established method of birth control such as hormonal preparations (e.g.,
             oral contraceptive tablets, hormonal implant device, hormone patch, or injectable
             contraceptive), or intrauterine device [IUD], for at least two months prior to
             screening, and in addition must use a barrier method, e.g., condom, diaphragm,
             contraceptive foam.

          -  Patient is willing and able to provide informed consent, after the nature of the study
             has been fully explained.

          -  Patient is an inpatient or outpatient who has a current DSM-IV-TR diagnosis of
             schizophrenia, as confirmed by the MINI-Plus.

          -  Patient must be experiencing an acute exacerbation of psychosis, with a baseline
             (Study Day 0) total score on the PANSS greater than '70'.

          -  Patient must have a score of '4' ("moderate") or more at baseline on two of the
             following four PANSS items: delusions, hallucinatory behaviors, conceptual
             disorganization or suspiciousness/persecution, where at least one of the two items
             must be either delusions or hallucinatory behaviors, and the total score on the four
             items must be greater than '17'.

          -  Patient must be experiencing an acute exacerbation of psychosis with a total score on
             the CGI-S of '4' ("moderate") or greater at baseline.

          -  Patient is willing to be hospitalized at screening, and willing to remain in the
             hospital at least 14 days after baseline (through Study Day 14) as clinically
             indicated, and must be willing to comply with all study related evaluations and
             procedures through Study Day 42.

          -  Patient has a caregiver or an identified responsible person (e.g., family member,
             social worker, nurse) who will support him/her to ensure compliance with the treatment
             and outpatient visits.

          -  Patient is willing to comply with not taking any prohibited medications during
             participation in the study.

        Exclusion Criteria:

          -  The presence of any of the following will exclude a patient from study enrolment:

        General

          -  Patient is unwilling or unable to provide informed consent.

          -  Patient is unwilling or unable, in the opinion of the Investigator, to comply with
             study instructions.

          -  If female, patient is pregnant, breast-feeding, has a positive urine pregnancy test at
             screening or baseline, or is of reproductive capacity and is unwilling to comply with
             accepted contraceptive methods during the study, ie, not using an oral contraceptive,
             hormonal patch or implant, injectable contraceptive or IUD, in combination with a
             barrier method (see Inclusion Criterion #2).

          -  Patient has made a plasma or blood donation within 14 days prior to the screening
             visit.

          -  Patient has participated in a prior clinical study of BL-1020 or any of its
             excipients, and/or has received an investigational drug within thirty days prior to
             screening.

          -  Patient is judged by the PI to be inappropriate for the study.