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AMG 333

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment74

FDA Designations

No designations recorded

Clinical trial landscape

AMG 333 · 1 trial · 1 indication

Phase 1 1
NCT01953341Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With MigrainesMigraine
COMPLETED74 Analytics
PHASE1COMPLETED
Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines
MigraineUnlock trial analytics

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 to 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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Competitive Landscape -Migraine 30 trials

Frequently asked questions about AMG 333

What is AMG 333 used for?

AMG 333 is an investigational small molecule being developed for the treatment of migraine. It is a neurology therapeutic that has been studied in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.

Who makes AMG 333?

AMG 333 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company conducted a Phase 1 study of the drug in healthy subjects and subjects with migraines.

What phase is AMG 333 in?

AMG 333 is in Phase 1 clinical development. It has completed a single-ascending dose study, and no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AMG 333 in?

AMG 333 has been studied in one completed Phase 1 trial, NCT01953341, titled 'Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines.' The trial enrolled 74 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is AMG 333 FDA approved?

AMG 333 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The drug is still in clinical development, and its safety and efficacy have not been established for regulatory approval.