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TV-1380

Phase 2

Cocaine Addiction | Small molecule | Psychiatry |Teva Pharmaceutical Industries Limited|Last Updated: Nov 5, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment208

FDA Designations

No designations recorded

Clinical trial landscape

TV-1380 · 1 trial · 1 indication

Phase 2 1
NCT01887366Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent SubjectsCocaine Addiction
COMPLETED208 Analytics
PHASE2COMPLETED
Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
Cocaine AddictionUnlock trial analytics

Study Endpoints

Primary Endpoints

Urine test for cocaine
Treatment Phase weeks 10 - 12

Secondary Endpoints

Percent of urine samples that are considered negative for cocaine metabolites.
Treatment Phase Weeks 5 -12
Summary of participants with adverse events
From signing of the informed consent form to the end of the follow-up period (Week 16)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TV-1380 150 mgEXPERIMENTAL -
TV-1380 300 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
TV-1380 150 mgDRUGSubjects assigned to TV-1380 150 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. The injection volume will be the same for all treatment groups. Therefore, to accommodate the volume required for the highest dosing group (3.0 mL), subjects in this group will receive 3.0 mL IM injection of TV-1380 150 mg (1.5 mL TV-1380 and 1.5 mL placebo/diluents).
TV-1380 300 mgDRUGSubjects assigned to TV-1380 300 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL TV-1380.
PlaceboDRUGSubjects assigned to placebo will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL placebo.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol. * Male or female aged 18-60 years (inclusive). * Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. * Other criteria apply; p...

Countries:United StatesSpain
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Frequently asked questions about TV-1380

What is TV-1380 used for?

TV-1380 is an investigational small molecule being developed for the treatment of cocaine addiction. It is intended to facilitate abstinence in cocaine-dependent subjects. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes TV-1380?

TV-1380 is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. The drug is currently in Phase 2 clinical development for the treatment of cocaine addiction.

What phase is TV-1380 in?

TV-1380 is in Phase 2 clinical development. It is an investigational drug for the treatment of cocaine addiction and has not been approved by regulatory authorities. One Phase 2 clinical trial for TV-1380 has been completed.

What clinical trials is TV-1380 in?

TV-1380 has been studied in one completed Phase 2 clinical trial, identified as NCT01887366. This trial evaluated the efficacy and safety of TV-1380 as a treatment for facilitation of abstinence in cocaine-dependent subjects, enrolling 208 participants in the United States and Spain.

Is TV-1380 the same as any other drug?

TV-1380 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is being developed by Teva Pharmaceutical Industries Limited for the treatment of cocaine addiction.