Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020

NCT00722176 | Completed Phase 2 DMC

• 1 other identifier: BL-1020 IIb (Extension)
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum Of Six Weeks With Bl-1020 (High Dose, Low Dose), Risperidone Or Placebo

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• changes from baseline in vital signs, laboratory and ECG evaluations, physical/neurological examination, Extrapyramidal Symptom Rating Scale (ESRS), and incidence of adverse events (AEs) and adverse drop-outs (ADOs).

  6 weeks

Secondary Outcomes (1)

• Comparisons between each of the BL-1020 treatment groups and the risperidone group

  6 weeks

Study Arms (3)

1

EXPERIMENTAL

BL-1020 10 mg

Drug: BL-1020

2

EXPERIMENTAL

BL-1020 10-30 mg

Drug: BL-1020 10-30 mg

3

ACTIVE COMPARATOR

risperidone

Drug: risperidone

Interventions

BL-1020 DRUG

10 mg

1

BL-1020 10-30 mg DRUG

BL-1020 10-30 mg

Also known as: BL-1020 High Dose

2

risperidone DRUG

risperidone

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-65 years of age at the time of entry into the BL-1020 IIb study
• Has provided informed consent to participate in the Extension Study
• Has completed 6 weeks of treatment and/or completed all efficacy assessments in Study BL-1020 IIb
• Females must have negative serum pregnancy test, or be post-menopausal, or if fecund, must practice established methods of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device \[IUD\]) for at least two months prior to screening
• Females must use an established method of birth control (as above) AND a barrier method (condom, diaphragm, contraceptive foam) while taking study medication
• 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
• Is willing to comply with not taking any prohibited medications during participation in the study
• Successful completion of End of Study assessments from BL-1020 IIb

You may not qualify if:

• Is unwilling or unable to provide informed consent
• Is unwilling or unable, in the opinion of the Investigator, to comply with study instructions
• Has a medical condition that would put him/her at risk for continuing in the study
• Score \> 9 on Modified InterSePT Scale for Suicidal Thinking (Modified ISST)
• Tested positive for drugs of abuse during the initial 6 weeks of treatment (Study BL-1020 IIb)
• Has been non-compliant with the study medication dosing and/or study procedures during the initial 6 weeks of treatment in Study BL-1020 IIb
• Is judged by the PI to be inappropriate for the study

Sponsors & Collaborators

• BioLineRx, Ltd.: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92868, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

perphenazine GABA ester; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mary Ann Knisevich, MD

  University Hills Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

US (1)