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battery-powered bion microstimulator system

Phase 1

Chronic Headaches | Unknown | Other |Boston Scientific Corporation|Last Updated: Aug 2, 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
UNCONTROLLED
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00205829Bion for Occipital Nerve StimulationPHASE1 COMPLETED 10Jun 1, 2004Jan 1, 2009Aug 2, 20121 United Kingdom
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Study Endpoints
Primary Endpoints
Demonstrate acceptable rate of adverse events.
Throughout the Study
The primary efficacy measure is a significant reduction in either headache frequency or severity
4 months Post-Activation Visit
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active TherapyEXPERIMENTALOccipital nerve stimulation (ONS) therapy delivered to a subject implanted with a bion ONS device
Interventions
NameTypeDescription
battery-powered bion(R) microstimulator systemDEVICEStimulation on from initial activation and on.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Be diagnosed with chronic migraine or primary chronic daily headache 2. Have headaches characterized by pain 3. Be 18 years of age or older; 4. Be willing and able to follow all study-related procedures during course of study; 5. Have exhibited refractoriness to two acute med...

Countries:United Kingdom
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