NCT00480571

Brief Summary

An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_2 schizophrenia

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 21, 2009

Status Verified

August 1, 2007

Enrollment Period

6 months

First QC Date

May 30, 2007

Last Update Submit

July 20, 2009

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

chronic schizophrenia or schizo-affective disorder

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and tolerability of two dose ranges (20-40 mg/day, 30-50 mg/day) of BL-1020 tri-mesylate (free base) in subjects with chronic schizophrenia or schizo-affective disorder

    6 weeks

Secondary Outcomes (3)

  • To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose

    6 weeks

  • To compare the efficacy of the two dose ranges of BL-1020

    6 weeks

  • To determine the pharmacokinetics of BL-1020 and its metabolites

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

BL 1020 low dose

Drug: BL-1020

2

EXPERIMENTAL

BL 1020 High Dose

Drug: BL 1020 High Dose

Interventions

BL-1020DRUG

BL-1020 Low Dose

1
BL 1020 High DoseDRUG

BL 1020 High Dose

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • to 65 years of age, inclusive
  • meet criteria for chronic (diagnosis established \> 1 year ago) schizophrenia with adequate psychotic symptoms as demonstrated by a PANSS total score \> 60
  • current diagnosis of schizophrenia (disorganized type, 295.10; catatonic type, 295.20; paranoid type, 295.30; undifferentiated type, 295.90) or schizoaffective disorder (295.7) in accordance with DSM-IV
  • Agree to be fully hospitalized until at least Day 14 of the study
  • Females must be of non-childbearing potential: surgically sterilized (i.e. tubal ligation), have had a hysterectomy prior to the screening phase, or be post-menopausal. Females who have been post-menopausal for more than 12 months but less than 24 months must have a FSH \> 40 mU/mL.

You may not qualify if:

  • Pregnant or lactating women
  • administration of clozapine within 60 days prior to Baseline
  • DSM-IV diagnosis of schizophreniform disorder (295.40) or schizophrenia residual sub-type (295.60), or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder
  • Severity of psychosis rated severe or higher (CGI-S 6 or 7)
  • Known suicidal risk (modified ISST score\>7)
  • Requiring disallowed concomitant psychotropic medication following enrolment into the study
  • Current evidence of clinically significant or unstable illness
  • Clinically significant abnormal laboratory data (e.g. creatinine, AST or ALT greater than 3 x the upper limit of normal, TSH\>10 IU) at screening, or any abnormal laboratory values that could interfere with the assessment of safety (e.g. blood cell count, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of Psychiatry, Sheba Medical Center

Tel Litwinsky, Israel

Location

Spitalul Clinic de Urgenţǎ Militar Central "Dr Carol Davila",

Bucharest, Str Mircea Vulcǎnescu 18, 010811, Romania

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

perphenazine GABA ester

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Michael Davidson, MD

    Dept. of Psychiatry, Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2007

First Posted

May 31, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 21, 2009

Record last verified: 2007-08

Locations

IL(1)RO(1)