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Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention (ARISE)

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ClinicalTrials.gov Identifier: NCT02483585
Recruitment Status : Completed
First Posted : June 29, 2015
Results First Posted : June 25, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Erenumab
Drug: Placebo
Enrollment 577
Recruitment Details This study was conducted at 69 centers in Denmark, France, Greece, Portugal, Russia, Spain, Switzerland, and the USA. Participants were enrolled from 20 July 2015 to 19 April 2016.
Pre-assignment Details Participants were randomized 1:1 to placebo or erenumab 70 mg once a month (QM). Randomization was stratified by region (North America vs Other) and treatment status with migraine prophylactic medication (current, prior, or no prior or current migraine prophylactic medication treatment).
Arm/Group Title Placebo Erenumab 70 mg QM
Hide Arm/Group Description Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase. Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Period Title: Double-blind Treatment Phase
Started 291 286
Received Treatment 289 283
Completed 275 271
Not Completed 16 15
Reason Not Completed
Decision by Sponsor             1             1
Withdrawal by Subject             12             12
Lost to Follow-up             3             2
Period Title: Open-label Treatment Phase
Started 270 [1] 268 [2]
Completed 243 243
Not Completed 27 25
Reason Not Completed
Protocol-specified Criteria             6             5
Decision by Sponsor             0             1
Withdrawal by Subject             18             14
Lost to Follow-up             3             5
[1]
Five participants who completed the double-blind phase did not enter the open-label treatment phase
[2]
Three participants who completed the double-blind phase did not enter the open-label treatment phase
Arm/Group Title Placebo Erenumab 70 mg QM Total
Hide Arm/Group Description Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase. Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase. Total of all reporting groups
Overall Number of Baseline Participants 291 286 577
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 291 participants 286 participants 577 participants
42.2  (11.5) 42.3  (11.4) 42.3  (11.4)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 291 participants 286 participants 577 participants
18 - 64 years
290
  99.7%
283
  99.0%
573
  99.3%
65 - 74 years
1
   0.3%
3
   1.0%
4
   0.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 291 participants 286 participants 577 participants
Female
247
  84.9%
245
  85.7%
492
  85.3%
Male
44
  15.1%
41
  14.3%
85
  14.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 291 participants 286 participants 577 participants
Hispanic or Latino
34
  11.7%
23
   8.0%
57
   9.9%
Not Hispanic or Latino
257
  88.3%
263
  92.0%
520
  90.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 291 participants 286 participants 577 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
   0.7%
2
   0.3%
Black or African American
27
   9.3%
24
   8.4%
51
   8.8%
Multiple
2
   0.7%
1
   0.3%
3
   0.5%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
1
   0.2%
White
259
  89.0%
259
  90.6%
518
  89.8%
Other
2
   0.7%
0
   0.0%
2
   0.3%
Region  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 291 participants 286 participants 577 participants
North America
170
  58.4%
168
  58.7%
338
  58.6%
Other
121
  41.6%
118
  41.3%
239
  41.4%
Treatment Status with Migraine Prophylactic Medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 291 participants 286 participants 577 participants
Current migraine prophylactic medication treatment
18
   6.2%
17
   5.9%
35
   6.1%
Prior migraine prophylactic treatment only
120
  41.2%
119
  41.6%
239
  41.4%
No prior / current migraine prophylactic treatment
153
  52.6%
150
  52.4%
303
  52.5%
Disease Duration of Migraine With or Without Aura  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 291 participants 286 participants 577 participants
20.03  (12.08) 21.70  (12.62) 20.86  (12.37)
Monthly Migraine Days   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 291 participants 286 participants 577 participants
8.38  (2.60) 8.14  (2.65) 8.26  (2.62)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change From Baseline in Monthly Migraine Days at Week 12
Hide Description

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.

Time Frame 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly migraine days in the double-blind treatment phase.
Arm/Group Title Placebo Erenumab 70 mg QM
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Overall Number of Participants Analyzed 288 282
Least Squares Mean (Standard Error)
Unit of Measure: migraine days / month
-1.84  (0.21) -2.88  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg QM
Comments The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.
Type of Statistical Test Superiority
Comments A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the primary and efficacy secondary endpoints.
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-1.61 to -0.47
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12
Hide Description

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 last 4 weeks of double-blind treatment.

At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.

Time Frame 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly migraine days in the double-blind treatment phase. Participants with missing data at week 12 were counted as non-responders.
Arm/Group Title Placebo Erenumab 70 mg QM
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Overall Number of Participants Analyzed 288 282
Measure Type: Number
Unit of Measure: percentage of participants
29.5 39.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg QM
Comments Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
1.12 to 2.27
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days at Week 12
Hide Description

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.

The change from baseline in monthly acute migraine-specific treatment days was calculated as the number of migraine-specific treatment days during the last 4 weeks of the 12-week double-blind treatment phase – the number of migraine-specific treatment days during the 4-week baseline phase.

Time Frame 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly acute migraine-specific treatment days in the double-blind treatment phase.
Arm/Group Title Placebo Erenumab 70 mg QM
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Overall Number of Participants Analyzed 288 282
Least Squares Mean (Standard Error)
Unit of Measure: acute migraine treatment days / month
-0.62  (0.14) -1.21  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg QM
Comments Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-0.96 to -0.21
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With at Least a 5-point Reduction From Baseline in Average Impact on Everyday Activities Domain Score Measured by MPFID at Week 12
Time Frame 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted in the efficacy analysis set including participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in MPFID average impact on everyday activities domain score in the double-blind treatment phase. Participants with missing post-baseline data were counted as non-responders.
Arm/Group Title Placebo Erenumab 70 mg QM
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Overall Number of Participants Analyzed 288 282
Measure Type: Number
Unit of Measure: percentage of participants
35.8 40.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg QM
Comments Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.87 to 1.71
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With at Least a 5-Point Reduction From Baseline in Average Impact on Physical Impairment Domain Score Measured by MPFID at Week 12
Time Frame 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted in the efficacy analysis set including participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in MPFID average impact on physical impairment domain score in the double-blind treatment phase. Participants with missing post-baseline data were counted as non-responders.
Arm/Group Title Placebo Erenumab 70 mg QM
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Overall Number of Participants Analyzed 288 282
Measure Type: Number
Unit of Measure: percentage of participants
27.1 33.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg QM
Comments Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.92 to 1.90
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where:

Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE.

Time Frame From first dose of study drug up to 12 weeks after the last dose. The double-blind treatment phase was 12 weeks and the open-label treatment phase was 28 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
For the double-blind treatment phase adverse events were analyzed for all randomized participants who received at least one dose of study drug. For the open-label treatment phase adverse events were analyzed for all participants who received at least one dose of study drug in the open-label treatment phase.
Arm/Group Title Double-blind Treatment Phase (12 Weeks): Placebo Double-blind Treatment Phase (12 Weeks): Erenumab 70 mg QM Open-label Treatment Phase (28 Weeks): Erenumab 70 mg QM
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Participants received erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 during the open-label treatment phase.
Overall Number of Participants Analyzed 289 283 538
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
158
  54.7%
136
  48.1%
337
  62.6%
Adverse event Grade ≥ 2
96
  33.2%
72
  25.4%
245
  45.5%
Adverse event Grade ≥ 3
8
   2.8%
6
   2.1%
34
   6.3%
Adverse event Grade ≥ 4
0
   0.0%
0
   0.0%
2
   0.4%
Serious adverse events
5
   1.7%
3
   1.1%
15
   2.8%
AE leading to discontinuation of study drug
1
   0.3%
5
   1.8%
13
   2.4%
Fatal adverse events
0
   0.0%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Participants Who Developed Antibodies to Erenumab
Hide Description

Blood samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against erenumab. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based bioassay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay).

Developing antibody incidence indicates participants with a negative or no result at baseline and a positive result at any time post-baseline.

If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.

Transient indicates a negative result at the participant's last time point tested, for those participants with a positive binding/neutralizing result post-baseline.

Time Frame Baseline (the period prior to the first dose erenumab 70 mg) and post-baseline (the period after the first dose of erenumab 70 mg until 12 weeks after last dose, up to 48 weeks total)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of erenumab and with post-baseline data are included in the analysis.
Arm/Group Title Placebo Erenumab 70 mg QM
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the 28-week open-label treatment phase.
Overall Number of Participants Analyzed 269 279
Measure Type: Count of Participants
Unit of Measure: Participants
Binding antibody positive
25
   9.3%
24
   8.6%
-Transient binding antibody positive
10
   3.7%
11
   3.9%
Neutralizing antibody positive
0
   0.0%
2
   0.7%
-Transient neutralizing antibody positive
0
   0.0%
2
   0.7%
Time Frame From first dose of study drug up to 12 weeks after the last dose. The double-blind treatment phase was 12 weeks and the open-label treatment phase was 28 weeks.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Double-blind Treatment Phase (12 Weeks): Placebo Double-blind Treatment Phase (12 Weeks): Erenumab 70 mg QM Open-label Treatment Phase (28 Weeks): Erenumab 70 mg QM
Hide Arm/Group Description Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection the double-blind treatment phase. Participants received erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 during the open-label treatment phase
All-Cause Mortality
Double-blind Treatment Phase (12 Weeks): Placebo Double-blind Treatment Phase (12 Weeks): Erenumab 70 mg QM Open-label Treatment Phase (28 Weeks): Erenumab 70 mg QM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Double-blind Treatment Phase (12 Weeks): Placebo Double-blind Treatment Phase (12 Weeks): Erenumab 70 mg QM Open-label Treatment Phase (28 Weeks): Erenumab 70 mg QM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/289 (1.73%)   3/283 (1.06%)   15/538 (2.79%) 
Cardiac disorders       
Atrial fibrillation  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Myocardial ischaemia  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Eye disorders       
Iridocyclitis  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Visual acuity reduced  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Gastrointestinal disorders       
Abdominal pain lower  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Hepatobiliary disorders       
Cholecystitis acute  1  1/289 (0.35%)  0/283 (0.00%)  0/538 (0.00%) 
Immune system disorders       
Hypersensitivity  1  1/289 (0.35%)  0/283 (0.00%)  0/538 (0.00%) 
Infections and infestations       
Pneumococcal bacteraemia  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Pneumonia  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Post procedural infection  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Tooth abscess  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Urinary tract infection  1  0/289 (0.00%)  1/283 (0.35%)  0/538 (0.00%) 
Injury, poisoning and procedural complications       
Ligament rupture  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Post procedural pulmonary embolism  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Metabolism and nutrition disorders       
Hyponatraemia  1  1/289 (0.35%)  0/283 (0.00%)  0/538 (0.00%) 
Musculoskeletal and connective tissue disorders       
Flank pain  1  1/289 (0.35%)  0/283 (0.00%)  0/538 (0.00%) 
Intervertebral disc protrusion  1  0/289 (0.00%)  1/283 (0.35%)  0/538 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Papillary thyroid cancer  1  0/289 (0.00%)  0/283 (0.00%)  2/538 (0.37%) 
Uterine leiomyoma  1  1/289 (0.35%)  0/283 (0.00%)  1/538 (0.19%) 
Nervous system disorders       
Migraine  1  1/289 (0.35%)  1/283 (0.35%)  0/538 (0.00%) 
Syncope  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Psychiatric disorders       
Depression  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Reproductive system and breast disorders       
Endometriosis  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Laryngeal haematoma  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Skin and subcutaneous tissue disorders       
Urticaria  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Surgical and medical procedures       
Nasal septal operation  1  0/289 (0.00%)  0/283 (0.00%)  1/538 (0.19%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double-blind Treatment Phase (12 Weeks): Placebo Double-blind Treatment Phase (12 Weeks): Erenumab 70 mg QM Open-label Treatment Phase (28 Weeks): Erenumab 70 mg QM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   46/289 (15.92%)   54/283 (19.08%)   140/538 (26.02%) 
General disorders       
Injection site pain  1  12/289 (4.15%)  17/283 (6.01%)  30/538 (5.58%) 
Infections and infestations       
Upper respiratory tract infection  1  14/289 (4.84%)  18/283 (6.36%)  41/538 (7.62%) 
Viral upper respiratory tract infection  1  17/289 (5.88%)  17/283 (6.01%)  53/538 (9.85%) 
Nervous system disorders       
Migraine  1  7/289 (2.42%)  5/283 (1.77%)  28/538 (5.20%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02483585     History of Changes
Other Study ID Numbers: 20120297
2014-004463-20 ( EudraCT Number )
First Submitted: June 12, 2015
First Posted: June 29, 2015
Results First Submitted: May 21, 2018
Results First Posted: June 25, 2018
Last Update Posted: November 29, 2018