Recent Updates
Recently added Catalysts

bion microstimulator

Phase 1

Headache Disorders | Unknown | Other |Boston Scientific Corporation|Last Updated: Sep 5, 2008

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
UNCONTROLLED
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00205894Occipital Nerve Stimulation to Treat Chronic HeadachesPHASE1 COMPLETED 20 — — Jan 1, 2004Sep 1, 2007Sep 5, 20082 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
The primary safety measure is the incidence of major complications, defined as device or procedure related major adverse events that require medical and surgical intervention.
The primary efficacy measure is a significant reduction in the frequency, severity or duration of the headaches from the preoperative to the three-month follow-up period.
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
bion microstimulatorDEVICE -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Be diagnosed with chronic migraine, probable chronic migraine, and/or chronic cluster headache according to the 2004 IHS Classification Criteria (2nd ed.) or be diagnosed with migraine with or without aura 2. Be 18 years of age or older 3. Be willing and able to follow all st...

Countries:United States
Unlock Eligibility Criteria