Adults 18 to 66, any sex, with Treatment for Prevention of Chronic Migraine. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse EventsPrimary· From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).
Adverse events (AEs) were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate AE; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; urgent intervention indicated; Grade 5 = Death related to AE.
Any adverse event
Group
Value
95% CI
Erenumab
398
Adverse event grade ≥ 2
Group
Value
95% CI
Erenumab
302
Adverse event grade ≥ 3
Group
Value
95% CI
Erenumab
34
Adverse event grade ≥ 4
Group
Value
95% CI
Erenumab
0
Treatment-related adverse events
Group
Value
95% CI
Erenumab
114
Serious adverse events
Group
Value
95% CI
Erenumab
24
AE leading to discontinuation of erenumab
Group
Value
95% CI
Erenumab
16
Fatal adverse events
Group
Value
95% CI
Erenumab
0
CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-usePrimary· Day 29 (week 4) and day 57 (week 8) of the substudy
At the CHU substudy day 28 and day 56 visits, the site provided erenumab 140 mg to participants to self-administer at home on the following day. Study site staff then called the participants and asked if they administered a full, partial, or no dose of erenumab. A full dose was defined when the entire volume of both prefilled syringes or autoinjector/pens were injected.
Week 4
Group
Value
95% CI
Erenumab 140 mg PFS
25
Erenumab 140 mg AI/Pen
26
Week 8
Group
Value
95% CI
Erenumab 140 mg PFS
25
Erenumab 140 mg AI/Pen
25
Change From Study 20120295 Baseline in Monthly Migraine DaysSecondary· 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255
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 4 weeks prior to each study visit - the number of migraine days during the 4-week baseline phase.
Baseline
Group
Value
95% CI
Erenumab
18.11
± 4.53
Change from baseline at week 4
Group
Value
95% CI
Erenumab
-6.72
± 6.22
Change from baseline at week 8
Group
Value
95% CI
Erenumab
-7.38
± 6.50
Change from baseline at week 12
Group
Value
95% CI
Erenumab
-7.63
± 6.49
Change from baseline at week 24
Group
Value
95% CI
Erenumab
-8.36
± 6.29
Change from baseline at week 40
Group
Value
95% CI
Erenumab
-8.72
± 6.53
Change from baseline at week 52
Group
Value
95% CI
Erenumab
-9.29
± 6.64
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 BaselineSecondary· 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255
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 without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the 4 weeks prior to each study visit.
At least a 50% reduction from baseline (of study 20120295) in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the 4 weeks
Week 4
Group
Value
95% CI
Erenumab
39.2
35.3 – 43.3
Week 8
Group
Value
95% CI
Erenumab
45.6
41.6 – 49.7
Week 12
Group
Value
95% CI
Erenumab
45.7
41.6 – 49.9
Week 24
Group
Value
95% CI
Erenumab
53.6
49.2 – 58.0
Week 40
Group
Value
95% CI
Erenumab
55.6
50.9 – 60.2
Week 52
Group
Value
95% CI
Erenumab
59.0
54.0 – 63.8
Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment DaysSecondary· 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255
Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.
Baseline
Group
Value
95% CI
Erenumab
9.53
± 7.26
Change from baseline at Week 4
Group
Value
95% CI
Erenumab
-3.59
± 4.62
Change from baseline at Week 8
Group
Value
95% CI
Erenumab
-4.01
± 4.96
Change from baseline at Week 12
Group
Value
95% CI
Erenumab
-3.96
± 5.03
Change from baseline at Week 24
Group
Value
95% CI
Erenumab
-4.39
± 4.99
Change from baseline at Week 40
Group
Value
95% CI
Erenumab
-4.58
± 5.00
Change from baseline at Week 52
Group
Value
95% CI
Erenumab
-4.97
± 5.33
Change From Study 20120295 Baseline in Cumulative Monthly Headache HoursSecondary· 4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255
The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use.
A qualified headache was defined as follows:
* a qualified migraine headache (including an aura-only event that is treated with acute migraine-specific medication), or
* a qualified non-migraine headache, which is a headache that lasted continuously for ≥ 4 hours and was not a qualified migraine headache, or
* a headache of any duration for which acute headache treatment was administered.
Baseline
Group
Value
95% CI
Erenumab
226.84
± 125.54
Change from baseline at week 4
Group
Value
95% CI
Erenumab
-79.38
± 107.56
Change from baseline at week 8
Group
Value
95% CI
Erenumab
-85.24
± 110.24
Change from Baseline at week 12
Group
Value
95% CI
Erenumab
-89.30
± 111.47
Change from Baseline at week 24
Group
Value
95% CI
Erenumab
-100.41
± 112.30
Change from Baseline at week 40
Group
Value
95% CI
Erenumab
-101.07
± 111.77
Change from Baseline at week 52
Group
Value
95% CI
Erenumab
-107.44
± 113.60
CHU Substudy: Number of Participants With Adverse EventsSecondary· From first dose of erenumab in the CHU substudy to 28 days after last dose of erenumab in the CHU substudy; up to 12 weeks.
Adverse events were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Injection site reactions were derived from a Medical Dictionary for Regulatory Activities (MedDRA) query using a list of pre-specified preferred terms.
An adverse device effect (ADE) is any adverse event related to the use of a medical device.
Any adverse event
Group
Value
95% CI
Erenumab 140 mg PFS
2
Erenumab 140 mg AI/Pen
6
Adverse event grade ≥ 2
Group
Value
95% CI
Erenumab 140 mg PFS
1
Erenumab 140 mg AI/Pen
4
Adverse event grade ≥ 3
Group
Value
95% CI
Erenumab 140 mg PFS
0
Erenumab 140 mg AI/Pen
0
Adverse event grade ≥ 4
Group
Value
95% CI
Erenumab 140 mg PFS
0
Erenumab 140 mg AI/Pen
0
Serious adverse events
Group
Value
95% CI
Erenumab 140 mg PFS
0
Erenumab 140 mg AI/Pen
0
AE leading to discontinuation of erenumab
Group
Value
95% CI
Erenumab 140 mg PFS
0
Erenumab 140 mg AI/Pen
0
Fatal adverse events
Group
Value
95% CI
Erenumab 140 mg PFS
0
Erenumab 140 mg AI/Pen
0
Injection site reactions
Group
Value
95% CI
Erenumab 140 mg PFS
0
Erenumab 140 mg AI/Pen
1
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 12 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02174861.