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H-coil dTMS

Phase 2

Major Depressive Disorder | Unknown | Psychiatry |BrainsWay Ltd.|Last Updated: Jan 5, 2012

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00807105Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive EpisodePHASE2 COMPLETED 29Jun 1, 2008May 1, 2010Jan 5, 20121 Israel
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Study Endpoints
Primary Endpoints
response in HAMDS
1 YEAR
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
depressive patientsEXPERIMENTALpatients suffering from deppresion
Interventions
NameTypeDescription
H-coil dTMSDEVICEtreatment with deep TMS stimulation.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * MDD patients Exclusion Criteria: * risk factors for convulsions

Countries:Israel
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