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BL-1020

Phase 2

Schizophrenia | Small molecule | Psychiatry |BioLineRx Ltd.|Last Updated: Jun 29, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment670
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00567710A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II StudyPHASE2 COMPLETED 360Jul 1, 2008Sep 1, 2009Jun 29, 20101 United States
NCT00722176Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020PHASE2 COMPLETED 220Jun 1, 2008Dec 1, 2009Jun 29, 20101 United States
NCT00480571Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective DisorderPHASE2 COMPLETED 90Jun 1, 2007Dec 1, 2007Jul 21, 20092 Israel, Romania
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Study Endpoints
Primary Endpoints
to evaluate the safety and tolerability of two dose ranges
6 weeks
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
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 Endpoints
to evaluate the efficacy of two dose ranges
6 weeks
Comparisons between each of the BL-1020 treatment groups and the risperidone group
6 weeks
To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IEXPERIMENTALBL - 1020 lowdose
IIEXPERIMENTALBL 1020 high dose
IIIPLACEBO_COMPARATOR -
IVACTIVE_COMPARATORRisperidone
1EXPERIMENTALBL-1020 10 mg
2EXPERIMENTALBL-1020 10-30 mg
3ACTIVE_COMPARATORrisperidone
Interventions
NameTypeDescription
BL - 1020DRUG10 mg/day
PlaceboDRUGCapsules
RisperidoneDRUGCapsules
BL-1020DRUG10 mg
BL-1020 10-30 mgDRUGBL-1020 10-30 mg
BL 1020 High DoseDRUGBL 1020 High Dose
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 de...

Countries:United StatesIsraelRomania
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