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Erenumab Dose 1

Phase 3

Migraine | Small molecule | Neurology |Amgen Inc.|Last Updated: Jan 20, 2026

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_CONTROLLEDDMCBiomarker
Total Trials10
Total Enrollment3,636
FDA Designations
No designations recorded
Clinical Trials (10)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03832998Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic MigrainePHASE3 COMPLETED 284Sep 5, 2019Jan 7, 2026Jan 20, 2026101 United States, Belgium +11
NCT03836040Efficacy and Safety of Erenumab in Pediatric Participants With Episodic MigrainePHASE3 ACTIVE NOT_RECRUITING 457Jul 19, 2019Nov 15, 2026Dec 23, 2025119 United States, Belgium +14
NCT03812224A Controlled Trial of Erenumab in Migraine PreventionPHASE3 COMPLETED 261Apr 12, 2019Nov 25, 2020Feb 21, 202441 Japan
NCT02483585Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine PreventionPHASE3 COMPLETED 577Jul 20, 2015Mar 20, 2017Oct 12, 202276 United States, Denmark +6
NCT02456740Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine PreventionPHASE3 COMPLETED 955Jul 17, 2015Jun 19, 2017Oct 12, 2022129 United States, Austria +11
NCT02630459A Safety and Efficacy Study to Evaluate AMG 334 in Migraine PreventionPHASE2 COMPLETED 475Jan 6, 2016Jun 5, 2019Oct 12, 202244 Japan
NCT01952574Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine PreventionPHASE2 COMPLETED 483Aug 6, 2013Nov 12, 2019Oct 12, 202266 United States, Canada +5
NCT02542605To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine PatientsPHASE1 COMPLETED 35Nov 11, 2015Nov 8, 2017Jun 3, 20193 United States, Belgium +1
NCT01723514Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine PatientsPHASE1 COMPLETED 48Nov 14, 2012Jul 10, 2014Jan 18, 20191 Belgium
NCT01688739Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine PatientsPHASE1 COMPLETED 61Mar 13, 2012Mar 27, 2013Jan 18, 20191 Belgium
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Study Endpoints
Primary Endpoints
Change from baseline in MMDs
Baseline through week 12 of DBTP

To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of DBTP.

Change From Baseline in Mean Monthly Migraine Days (MMD) Over Months 4, 5, and 6 of the Double-blind Treatment Period
4-week baseline period and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period

A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura, lasting for ≥ 4 hours, and meeting at least 1 of the following criteria: 1. ≥ 2 of the following pain features: * unilateral * throbbing * moderate to severe * exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: * nausea * vomiting * photophobia and phonophobia The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period minus the number of migraine days during the 4-week baseline period.

Change From Baseline in Monthly Migraine Days at Week 12
4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase

A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.

Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period
4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase

A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.

Change From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6
4-week baseline phase and months 4, 5 and 6 of DBTP.

A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: a) ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity; b) ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia. Change from baseline was calculated using the mean monthly migraine days from months 4, 5 and 6 of the DBTP minus the number of migraine days during the 4-week baseline phase. Least squares (LS) mean was estimated using a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (current, prior only, or no prior/current treatment), and baseline value as covariates.

CHU Sub-Study: Participant-Reported Outcome of Attempted Full-Dose Administration at Day 29 (Week 4) and Day 57 (Week 8)
CHU day 29 (week 4) and day 57 (week 8)

On CHU day 29 and day 57, site staff interviewed sub-study participants and asked if they administered a full, partial, or no dose of erenumab (after explaining that a full dose means that the entire volume of the AI/pen was injected) and documented the participant's response in the electronic case report form. Data presented are the percentage of participants who reported "full administration," "not full administration," or "discontinued investigational product (ie, no dose)." (Day 1 of the CHU substudy occurred at any OLTP study visit \[up to week 88\] as long as the participant had previously received at least 1 OL dose of erenumab 140 mg.)

CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab
CHU substudy day 29 (week 4) and day 57 (week 8)

To assess participants ability to administer a full dose of erenumab in home-use at day 29 (week 4) and day 57 (week 8), site staff called participants and asked whether the participant administered a full, partial, or no dose of erenumab. A full dose means that the entire volume of both prefilled syringes or autoinjector/pens were injected. Discontinued prior to dosing day indicates participants who had discontinued the investigational product and did not attempt to self-administer on day 29 or 57.

Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion
Part B randomization phase day 8 plus 24 hours.

On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion. A MLA was defined as fulfilling 1 of the 2 criteria: 1. Headache with at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, aggravated by/causing avoidance of routine physical activity. Additionally, during the headache at least 1 of the following: nausea and/or vomiting, photophobia or phonophobia. 2. Headache described as mimicking usual migraine attack treated with triptan.

Number of Participants With Adverse Events
From first dose of study drug until a maximum of 168 days after last dose (225 days)

An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: * fatal * life-threatening (places the subject at immediate risk of death) * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.

Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
From first dose of study drug until a maximum of 168 days after last dose (225 days)

The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.

Number of Participants Who Developed Anti-erenumab Antibodies
From first dose of study drug until a maximum of 168 days after last dose (225 days)

Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.

Secondary Endpoints
Change in monthly headache days from baseline
Baseline through week 12 of the DBTP
Proportion of participants with at least 50% reduction in MMDs from baseline
Baseline through week 12 of the DBTP
Change in MMDs from baseline to the average of the first 3 months
Baseline through week 12 of the DBTP
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Level 1EXPERIMENTALParticipants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
Dose Level 2EXPERIMENTALParticipants will be randomized to one of two doses determined by their body-weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
PlaceboPLACEBO_COMPARATOR -
ErenumabEXPERIMENTALParticipants were to receive erenumab 70 mg once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period.
Erenumab 70 mg QMEXPERIMENTALParticipants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.
Erenumab 140 mg QMEXPERIMENTALParticipants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.
Double Blind Treatment Phase (DBTP): PlaceboPLACEBO_COMPARATORParticipants received placebo by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
DBTP: Erenumab 28 mg QMEXPERIMENTALParticipants received erenumab 28 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
DBTP: Erenumab 70 mg QMEXPERIMENTALParticipants received erenumab 70 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
DBTP: Erenumab 140 mg QMEXPERIMENTALParticipants received erenumab 140 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Open-Label Treatment Phase (OLTP): Erenumab 70-140 mg QMEXPERIMENTALParticipants received an erenumab dose of 70 and/or 140 mg QM SC (depending on the participant's visit completion status after Institutional Review Board \[IRB\] approval of Protocol Amendment 2) in the OLTP for a total of 76 weeks.
CHU Sub-Study: Two 70 mg/mL AI/pensEXPERIMENTALA subset of participants in the OLTP randomized to self administer erenumab via two 70 mg/mL autoinjector (AI)/pens on day 29 and day 57 of the CHU Sub-Study
CHU Sub-Study: One 140 mg/mL AI/penEXPERIMENTALA subset of participants in the OLTP randomized to self administer erenumab via one 140 mg/mL AI/pen on day 29 and day 57 of the CHU Sub-Study
Erenumab 7 mg QMEXPERIMENTALParticipants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase. In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
Erenumab 21 mg QMEXPERIMENTALParticipants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase. In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
CHU Substudy: Erenumab 140 mg PFSEXPERIMENTALParticipants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
CHU Substudy: Erenumab 140 mg AI/PenEXPERIMENTALParticipants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
PACAP-38 Challenge AgentOTHERIn Part A, 4 cohorts of 2 to 5 participants sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 for 2.5, 5, 7.5 and 10 minutes each in order to determine the dose for Part B.
Interventions
NameTypeDescription
Erenumab Dose 1DRUGParticipants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
Erenumab Dose 2DRUGParticipants in the low body-weight group at day 1 who are randomized to Dose Level 2 and participants in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
Erenumab Dose 3DRUGParticipants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
PlaceboOTHERPlacebo matching dose for erenumab dose 1, 2 and 3.
ErenumabDRUGAdministered by subcutaneous injection once a month
Erenumab PFSDRUGErenumab supplied in a single-use prefilled syringe for self-administration in the CHU substudy
Erenumab AI/PenDRUGErenumab supplied in a single-use autoinjector/pen for self-administration in the CHU substudy
PACAP-38 Challenge AgentDRUGAdministered by intravenous infusion during Part A of the study for dose selection for Part B. Administered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack.
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Eligibility Criteria
Age Range6 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites101

Inclusion Criteria: * Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study. * Participant's parent or legal representative has provided written informed consent...

Countries:United StatesBelgiumCanadaColombiaFinlandGermanyHungaryItalyJapanPolandPuerto RicoRussiaUnited KingdomPortugalSpainSwitzerlandDenmarkFranceGreeceAustriaCzechiaNetherlandsSlovakiaSwedenTurkey (Türkiye)Norway
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT03836040primaryCompletionDate: changed
LOWMay 24, 2026NCT03836040studyFirstPostDate: changed