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Erenumab

Phase 2

Post-Traumatic Headache | Small molecule | Other |Amgen Inc.|Last Updated: Oct 23, 2025

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04098250Multidisciplinary Translational Approach to Investigate Mechanisms Predictors & Prevention of Persistent PTHPHASE2 COMPLETED 6 — — Jan 4, 2021Jan 10, 2024Oct 23, 20255 United States
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Study Endpoints
Primary Endpoints
Change in the Number of Days Experiencing Moderate-to-Severe Headaches
Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported

The number of days where subjects experienced moderate-to-severe headaches. This was measured at baseline, 9, 10, 11 and 12 weeks after administration of first dose of erenumab 140 mg or placebo. The change from baseline to week 12 is reported.

Secondary Endpoints
Responder Rate
Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported
Chronic Headache
Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported
Change in the Headache Impact Test (HIT-6)
Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
ErenumabEXPERIMENTAL140 mg erenumab
PlaceboPLACEBO_COMPARATORplacebo comparator
Interventions
NameTypeDescription
ErenumabDRUGa CGRP receptor monoclonal antibody
PlaceboOTHERPlacebo
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Have a diagnosis of acute PTH attributed to mild traumatic injury to the head as defined by the International Classification of Headache Disorders (ICHD-3). * PTH onset 7-56 days prior to the time of enrollment * Adults 18-70 years of age * Willing to be randomized to either o...

Countries:United States
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