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AMG 333

Phase 1

Migraine | Small molecule | Neurology |Amgen Inc.|Last Updated: Dec 9, 2014

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment74
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01953341Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With MigrainesPHASE1 COMPLETED 74Oct 1, 2013Nov 1, 2014Dec 9, 20141 United States
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Study Endpoints
Primary Endpoints
Primary
Up to 29 days

Treatment-emergent adverse events, including changes in vital signs, 12-lead ECGs, clinical laboratory safety tests, and physical and neurological assessments

Secondary Endpoints
Secondary Outcome Measures
Up to 29 Days
Secondary
Up to 29 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
AMG 333EXPERIMENTALSubjects will receive a single oral dose of AMG 333 .
PlaceboPLACEBO_COMPARATORSubjects will receive a single oral dose of placebo.
Interventions
NameTypeDescription
AMG 333DRUGOral administration available in varying dose strength.
PlaceboDRUGPlacebo containing no active drug
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects with or without migraines ≥18 and ≤55 years of age at the time of screening, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician. Exclusion Criteria: ...

Countries:United States
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