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BL-1020

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment670

FDA Designations

No designations recorded

Clinical trial landscape

BL-1020 · 3 trials · 2 indications

Phase 2 3
NCT00567710A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II StudySchizophrenia
COMPLETED360 Analytics
NCT00722176Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020Schizophrenia
COMPLETED220 Analytics
NCT00480571Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective DisorderSchizophrenia
COMPLETED90 Analytics
PHASE2COMPLETED
A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder
SchizophreniaUnlock trial analytics

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 to 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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Frequently asked questions about BL-1020

What is BL 1020 used for?

BL 1020 is an investigational small molecule being studied for the treatment of schizophrenia and schizoaffective disorder. It has also been evaluated in healthy subjects in early-phase trials. The drug is not approved and remains in clinical development.

Who makes BL 1020?

BL 1020 is being developed by BioLineRx Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BLRX. The company has sponsored clinical trials of the drug in schizophrenia and related conditions.

What phase is BL 1020 in?

BL 1020 is in Phase 1 clinical development. While some completed trials were Phase 2 studies, the most advanced stage reported for the drug is Phase 1. It is an investigational agent and has not received regulatory approval.

What clinical trials is BL 1020 in?

BL 1020 has been studied in several completed trials, including NCT00480246, a PET study in healthy male subjects; NCT00480571, a safety and tolerability study in schizophrenia; NCT00567710, a randomized Phase II study; and NCT00722176, a long-term extension study.

What does BL 1020 target?

BL 1020 targets the dopamine D2 receptor, as assessed in a PET study using [11C]raclopride to measure receptor occupancy in the brain after single doses of the drug. This mechanism is relevant to its investigation in schizophrenia.

Is BL 1020 the same as perphenazine?

BL 1020 is not the same as perphenazine. In a clinical trial, BL-1020 was compared with perphenazine to assess dopamine D2 receptor occupancy in healthy subjects. They are distinct compounds, with perphenazine serving as a reference in that study.