Clinical trial NCT00722176: Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: BioLineRx, Ltd.
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This is a six-week, randomized, double blind, multi-center, parallel group Extension to the BL-1020 IIb study. In this Extension Study in patients hospitalized with schizophrenia who were previously treated in the BL-1020 IIb study with BL-1020 (low dose: 10 mg/day; high dose: target dose 30 mg/day), risperidone (target dose: 8 mg/day) or placebo after experiencing an acute exacerbation of schizophrenia. Patients who completed the 6 week treatment period and/or all efficacy assessments in Study BL-1020 IIb are eligible to continue double-blind treatment in this optional 6 week Extension Study. Approximately 220 patients will be enrolled in this study: Treatment Group IE (n=82, 10 mg/day BL-1020); Treatment Group IIE (n=82: target dose 30 mg/day BL-1020); Treatment Group IIIE (n=55; target dose 8 mg/day risperidone). Study drug (BL-1020 or risperidone) will be administered orally, once daily, in a doubleblinded manner, during this six-week Extension Study

Eligibility criteria: Inclusion Criteria:

1. Male or female, 18-65 years of age at the time of entry into the BL-1020 IIb study
2. Has provided informed consent to participate in the Extension Study
3. Has completed 6 weeks of treatment and/or completed all efficacy assessments in Study BL-1020 IIb
4. 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
5. Females must use an established method of birth control (as above) AND a barrier method (condom, diaphragm, contraceptive foam) while taking study medication
6. 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
7. Is willing to comply with not taking any prohibited medications during participation in the study
8. Successful completion of End of Study assessments from BL-1020 IIb

Exclusion Criteria:

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

Primary outcomes:
measure: 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).
timeFrame: 6 weeks
Secondary outcomes:
measure: Comparisons between each of the BL-1020 treatment groups and the risperidone group
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University Hills Clinical Research
name: Mary Ann Knisevich, MD
role: PRINCIPAL_INVESTIGATOR
References: