Trial Outcomes & Findings for A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention. (NCT NCT02174861)

Last Updated: 2022-10-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

609 participants

Primary outcome timeframe

From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).

Results posted on

2022-10-12

Participant Flow

Participants were enrolled at 64 centers across North America and Europe from 30 June 2014 to 4 March 2016. Participants who completed the 12-week double-blind treatment of the parent Study 20120295 (NCT02066415) and met all Study 20130255 eligibility criteria were eligible for enrollment into this study.

Participants at sites in the United States, Sweden, and Germany had the option of enrolling in the Clinical Home Use (CHU) Substudy to assess their ability to self-administer 140 mg erenumab for in-home use. Participants in the substudy were randomized 1:1 to self-administer erenumab using either a prefilled syringe or autoinjector/pen.

Participant milestones

Participant milestones
Measure	Erenumab Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.
Overall Study STARTED	609
Overall Study Enrolled in CHU Substudy	53
Overall Study COMPLETED	451
Overall Study NOT COMPLETED	158

Reasons for withdrawal

Reasons for withdrawal
Measure	Erenumab Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.
Overall Study Decision by sponsor	8
Overall Study Withdrawal by Subject	124
Overall Study Lost to Follow-up	26

Baseline Characteristics

A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erenumab n=609 Participants Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.
Age, Continuous	42.5 years STANDARD_DEVIATION 11.3 • n=5 Participants
Age, Customized 18 - 64 years	608 Participants n=5 Participants
Age, Customized 65 - 74 years	1 Participants n=5 Participants
Sex: Female, Male Female	509 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	584 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	25 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White	574 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).

Population: All enrolled participants who received at least 1 dose of erenumab

Outcome measures

Outcome measures
Measure	Erenumab n=609 Participants Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.	Erenumab 140 mg AI/Pen Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a autoinjector/pen (AI/Pen).
Number of Participants With Adverse Events Any adverse event	398 Participants	—
Number of Participants With Adverse Events Adverse event grade ≥ 2	302 Participants	—
Number of Participants With Adverse Events AE leading to discontinuation of erenumab	16 Participants	—
Number of Participants With Adverse Events Fatal adverse events	0 Participants	—
Number of Participants With Adverse Events Adverse event grade ≥ 3	34 Participants	—
Number of Participants With Adverse Events Adverse event grade ≥ 4	0 Participants	—
Number of Participants With Adverse Events Treatment-related adverse events	114 Participants	—
Number of Participants With Adverse Events Serious adverse events	24 Participants	—

PRIMARY outcome

Timeframe: Day 29 (week 4) and day 57 (week 8) of the substudy

Population: All randomized participants who received at least 1 dose of erenumab in the CHU 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.

Outcome measures

Outcome measures
Measure	Erenumab n=27 Participants Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.	Erenumab 140 mg AI/Pen n=26 Participants Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a autoinjector/pen (AI/Pen).
CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use Week 4	25 Participants	26 Participants
CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use Week 8	25 Participants	25 Participants

SECONDARY outcome

Timeframe: 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

Population: Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The number of participants analyzed includes participants with available data at each time point.

Outcome measures

Outcome measures
Measure	Erenumab n=605 Participants Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.	Erenumab 140 mg AI/Pen Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a autoinjector/pen (AI/Pen).
Change From Study 20120295 Baseline in Monthly Migraine Days Change from baseline at week 24	-8.36 migraine days / month Standard Deviation 6.29	—
Change From Study 20120295 Baseline in Monthly Migraine Days Change from baseline at week 40	-8.72 migraine days / month Standard Deviation 6.53	—
Change From Study 20120295 Baseline in Monthly Migraine Days Change from baseline at week 52	-9.29 migraine days / month Standard Deviation 6.64	—
Change From Study 20120295 Baseline in Monthly Migraine Days Baseline	18.11 migraine days / month Standard Deviation 4.53	—
Change From Study 20120295 Baseline in Monthly Migraine Days Change from baseline at week 4	-6.72 migraine days / month Standard Deviation 6.22	—
Change From Study 20120295 Baseline in Monthly Migraine Days Change from baseline at week 8	-7.38 migraine days / month Standard Deviation 6.50	—
Change From Study 20120295 Baseline in Monthly Migraine Days Change from baseline at week 12	-7.63 migraine days / month Standard Deviation 6.49	—

SECONDARY outcome

Timeframe: 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

Population: Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.

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 prior to each study visit \* 100 / baseline monthly migraine days was less than or equal to -50%.

Outcome measures

Outcome measures
Measure	Erenumab n=605 Participants Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.	Erenumab 140 mg AI/Pen Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a autoinjector/pen (AI/Pen).
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline Week 4	39.2 percentage of participants Interval 35.3 to 43.3	—
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline Week 8	45.6 percentage of participants Interval 41.6 to 49.7	—
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline Week 12	45.7 percentage of participants Interval 41.6 to 49.9	—
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline Week 24	53.6 percentage of participants Interval 49.2 to 58.0	—
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline Week 40	55.6 percentage of participants Interval 50.9 to 60.2	—
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline Week 52	59.0 percentage of participants Interval 54.0 to 63.8	—

SECONDARY outcome

Timeframe: 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

Population: Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.

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.

Outcome measures

Outcome measures
Measure	Erenumab n=605 Participants Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.	Erenumab 140 mg AI/Pen Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a autoinjector/pen (AI/Pen).
Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days Baseline	9.53 acute migraine treatment days / month Standard Deviation 7.26	—
Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days Change from baseline at Week 4	-3.59 acute migraine treatment days / month Standard Deviation 4.62	—
Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days Change from baseline at Week 8	-4.01 acute migraine treatment days / month Standard Deviation 4.96	—
Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days Change from baseline at Week 40	-4.58 acute migraine treatment days / month Standard Deviation 5.00	—
Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days Change from baseline at Week 52	-4.97 acute migraine treatment days / month Standard Deviation 5.33	—
Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days Change from baseline at Week 12	-3.96 acute migraine treatment days / month Standard Deviation 5.03	—
Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days Change from baseline at Week 24	-4.39 acute migraine treatment days / month Standard Deviation 4.99	—

SECONDARY outcome

Timeframe: 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

Population: Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.

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.

Outcome measures

Outcome measures
Measure	Erenumab n=605 Participants Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.	Erenumab 140 mg AI/Pen Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a autoinjector/pen (AI/Pen).
Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours Change from Baseline at week 24	-100.41 hours / month Standard Deviation 112.30	—
Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours Baseline	226.84 hours / month Standard Deviation 125.54	—
Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours Change from baseline at week 4	-79.38 hours / month Standard Deviation 107.56	—
Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours Change from baseline at week 8	-85.24 hours / month Standard Deviation 110.24	—
Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours Change from Baseline at week 12	-89.30 hours / month Standard Deviation 111.47	—
Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours Change from Baseline at week 40	-101.07 hours / month Standard Deviation 111.77	—
Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours Change from Baseline at week 52	-107.44 hours / month Standard Deviation 113.60	—

SECONDARY outcome

Timeframe: 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.

Population: All randomized participants who received at least one dose of erenumab in the CHU substudy.

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.

Outcome measures

Outcome measures
Measure	Erenumab n=27 Participants Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.	Erenumab 140 mg AI/Pen n=26 Participants Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a autoinjector/pen (AI/Pen).
CHU Substudy: Number of Participants With Adverse Events Serious adverse events	0 Participants	0 Participants
CHU Substudy: Number of Participants With Adverse Events Any adverse event	2 Participants	6 Participants
CHU Substudy: Number of Participants With Adverse Events Adverse event grade ≥ 2	1 Participants	4 Participants
CHU Substudy: Number of Participants With Adverse Events Adverse event grade ≥ 3	0 Participants	0 Participants
CHU Substudy: Number of Participants With Adverse Events Adverse event grade ≥ 4	0 Participants	0 Participants
CHU Substudy: Number of Participants With Adverse Events AE leading to discontinuation of erenumab	0 Participants	0 Participants
CHU Substudy: Number of Participants With Adverse Events Fatal adverse events	0 Participants	0 Participants
CHU Substudy: Number of Participants With Adverse Events Injection site reactions	0 Participants	1 Participants
CHU Substudy: Number of Participants With Adverse Events Adverse device effects	0 Participants	0 Participants

Adverse Events

Erenumab

Serious events: 24 serious events

Other events: 162 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erenumab n=609 participants at risk Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.
Congenital, familial and genetic disorders Myocardial bridging	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophagitis	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Volvulus	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Alcoholic liver disease	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendicitis	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis viral	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural oedema	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Costochondritis	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.49% 3/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Medication overuse headache	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Migraine	0.66% 4/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Presyncope	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Radicular syndrome	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Transient ischaemic attack	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Vestibular migraine	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Alcoholism	0.16% 1/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	0.33% 2/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Other adverse events
Measure	Erenumab n=609 participants at risk Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.
Infections and infestations Sinusitis	7.2% 44/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	7.4% 45/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Viral upper respiratory tract infection	15.8% 96/609 • From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER