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transcranial Direct Current Stimulation

Phase 2

Alcohol Dependence | Unknown | Other |Harvard Bioscience, Inc.|Last Updated: Dec 24, 2013

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_CONTROLLED
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01330394Transcranial Direct Current Stimulation Over Dorsolateral Prefrontal Cortex in AlcoholismPHASE2 COMPLETED 33Jun 1, 2011Jul 1, 2013Dec 24, 20132 Brazil
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Study Endpoints
Primary Endpoints
Use of Alcohol
6 months after treatment

Relapse to the use of alcohol to a usual pattern observed before treatment (for example, if a patient was used to have 10 drinks/day before treatment and start to have about this amount of drinks/day with similar behavior seen before treatment, it would be considered a relapse).

Secondary Endpoints
Event-related Potentials
one year and a half
Cognitive Tasks
one year and a half
Quality of Life
one year and a half
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
sham-tDCS controlSHAM_COMPARATORsimulate control for transcranial Direct Current Stimulation
active tDCSACTIVE_COMPARATORactive transcranial Direct Current Stimulation
Interventions
NameTypeDescription
transcranial Direct Current StimulationDEVICEtranscranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 1 mA, during 10 min) will be applied over the left dorsolateral prefrontal cortex once a week for 5 consecutive weeks.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Subjects with diagnosis confirmed by Diagnostic and Statistical Manual of Mental Disorders in its Fourth Edition (DSM-IV); * Alcoholics classified as type IV according to Lesch's Typology. * 18-65 years old from both genders; * clinically stable and not requiring hospitalizati...

Countries:Brazil
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