Recent Updates
Recently added Catalysts

Medtronic Activa Deep Brain Stimulation

Phase 2

Obsessive-Compulsive Disorder | Unknown | Psychiatry |Medtronic plc.|Last Updated: Feb 25, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01061983Electrical Stimulation of the Internal Capsule for Intractable Obsessive-compulsive Disorder (OCD)PHASE2 COMPLETED 5 — — Jan 1, 2001Oct 1, 2012Feb 25, 20131 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Obsessive-compulsive disorder (OCD) severity (Yale-Brown Obsessive-Compulsive Scale)
Measured at baseline, then monthly for nine months, then every three months during the open continuation phase
Secondary Endpoints
Depression severity (Hamilton Depression Scale), Anxiety (Hamilton Anxiety Scale), and neuropsychological battery.
At baseline, monthly for 9 months, then every 3 months for the continuation of the open phase.
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Deep Brain StimulationEXPERIMENTALParticipants will receive deep brain stimulation.
Interventions
NameTypeDescription
Medtronic Activa Deep Brain StimulationDEVICEIn DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * OCD, diagnosed by Structural Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity with a Yale-Brown Obsessive-Compulsive Scale (YBOCS) score of 28 and a Global Assessment of Function (GAF) score of 45 or less. * Persistence of this level of impairment fo...

Countries:United States
Unlock Eligibility Criteria