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A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02066415
Recruitment Status : Completed
First Posted : February 19, 2014
Results First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Treatment for Prevention of Chronic Migraine
Interventions Biological: Erenumab
Drug: Placebo
Enrollment 667
Recruitment Details

This study was conducted at 69 centers in Canada, Czech Republic, Denmark, Germany, Finland, Norway, Poland, Sweden, United Kingdom, and the United States of America (USA).

The first participant was enrolled on 05 March 2014 and the last participant enrolled on 05 November 2015.

Pre-assignment Details Participants were randomized in a 3:2:2 ratio to receive placebo, erenumab 70 mg, or erenumab 140 mg. Randomization was stratified by region (North America vs Other) and medication overuse status at baseline (Yes vs No).
Arm/Group Title Placebo Erenumab 70 mg Erenumab 140 mg
Hide Arm/Group Description Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection. Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Period Title: Overall Study
Started 286 191 190
Received Study Drug 282 190 188
Completed 265 184 182
Not Completed 21 7 8
Reason Not Completed
Decision by Sponsor             5             4             2
Withdrawal by Subject             9             1             4
Lost to Follow-up             7             2             2
Arm/Group Title Placebo Erenumab 70 mg Erenumab 140 mg Total
Hide Arm/Group Description Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection. Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. Total of all reporting groups
Overall Number of Baseline Participants 286 191 190 667
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 286 participants 191 participants 190 participants 667 participants
42.1  (11.3) 41.4  (11.3) 42.9  (11.1) 42.1  (11.3)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 191 participants 190 participants 667 participants
18 to 64 years
285
  99.7%
191
 100.0%
190
 100.0%
666
  99.9%
65 to 74 years
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 191 participants 190 participants 667 participants
Female
226
  79.0%
166
  86.9%
160
  84.2%
552
  82.8%
Male
60
  21.0%
25
  13.1%
30
  15.8%
115
  17.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 191 participants 190 participants 667 participants
Hispanic or Latino
9
   3.1%
7
   3.7%
10
   5.3%
26
   3.9%
Not Hispanic or Latino
277
  96.9%
184
  96.3%
180
  94.7%
641
  96.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 191 participants 190 participants 667 participants
Asian
4
   1.4%
4
   2.1%
0
   0.0%
8
   1.2%
Black or African American
11
   3.8%
10
   5.2%
6
   3.2%
27
   4.0%
White
268
  93.7%
176
  92.1%
184
  96.8%
628
  94.2%
Other
3
   1.0%
1
   0.5%
0
   0.0%
4
   0.6%
Prior Migraine Prophylactic Medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 191 participants 190 participants 667 participants
Yes
218
  76.2%
138
  72.3%
136
  71.6%
492
  73.8%
No
68
  23.8%
53
  27.7%
54
  28.4%
175
  26.2%
Prior Migraine Prophylactic Treatment Failure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 191 participants 190 participants 667 participants
Yes
200
  69.9%
127
  66.5%
126
  66.3%
453
  67.9%
No
86
  30.1%
64
  33.5%
64
  33.7%
214
  32.1%
Region  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 191 participants 190 participants 667 participants
North America
135
  47.2%
91
  47.6%
89
  46.8%
315
  47.2%
Other
151
  52.8%
100
  52.4%
101
  53.2%
352
  52.8%
Medication Overuse Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 191 participants 190 participants 667 participants
Yes
117
  40.9%
79
  41.4%
78
  41.1%
274
  41.1%
No
169
  59.1%
112
  58.6%
112
  58.9%
393
  58.9%
[1]
Measure Description:

Medication overuse was defined as any of the following criteria being met during the baseline (BL) phase:

  • ≥ 15 days of simple analgesics (> 3 days/week in each week during BL with at least 5 diary days),
  • ≥ 10 days of triptans (> 2 days/week in each week during BL with at least 5 diary days),
  • ≥ 10 days of ergots (> 2 days/week in each week during BL with at least 5 diary days),
  • ≥ 10 days of combination therapy intake of any combination of ergots, triptans, opiates, combination-analgesic medications or simple analgesics (> 2 days/week in each week during BL with at least 5 diary days).
Monthly Migraine Days   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 286 participants 191 participants 190 participants 667 participants
18.22  (4.73) 17.85  (4.39) 17.78  (4.72) 17.99  (4.63)
[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.

Disease Duration of Migraine With or Without Aura   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 285 participants 191 participants 189 participants 665 participants
22.21  (12.63) 20.71  (12.83) 21.92  (11.80) 21.70  (12.46)
[1]
Measure Analysis Population Description: Participants with available data
1.Primary Outcome
Title Change From Baseline in Monthly Migraine Days
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 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 treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement. The number of participants analyzed includes those with observed data at week 12.
Arm/Group Title Placebo Erenumab 70 mg Erenumab 140 mg
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Overall Number of Participants Analyzed 267 178 182
Least Squares Mean (95% Confidence Interval)
Unit of Measure: migraine days / month
-4.18
(-4.86 to -3.50)
-6.64
(-7.47 to -5.81)
-6.63
(-7.45 to -5.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg
Comments The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), 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 2 erenumab doses and the primary and secondary endpoints.

This comparison was tested at a 2-sided significance level of 0.04.

Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -2.46
Confidence Interval (2-Sided) 95%
-3.52 to -1.39
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 140 mg
Comments The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), 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 2 erenumab doses and the primary and secondary endpoints.

This comparison was tested at a 2-sided significance level of 0.01.

Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -2.45
Confidence Interval (2-Sided) 95%
-3.51 to -1.38
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Baseline
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 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 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 treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description

The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement.

Participants with missing post-baseline data were counted as non-responders.

Arm/Group Title Placebo Erenumab 70 mg Erenumab 140 mg
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Overall Number of Participants Analyzed 281 188 187
Measure Type: Number
Unit of Measure: percentage of participants
23.5 39.9 41.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg
Comments Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).
Type of Statistical Test Superiority
Comments This comparison was tested at a 2-sided significance level of 0.04.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.18
Confidence Interval (2-Sided) 95%
1.46 to 3.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 140 mg
Comments Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).
Type of Statistical Test Superiority
Comments This comparison was tested at a 2-sided significance level of 0.01.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.34
Confidence Interval (2-Sided) 95%
1.56 to 3.51
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days
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.
Time Frame 4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description

The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement.

The number of participants analyzed includes those with observed data at week 12.

Arm/Group Title Placebo Erenumab 70 mg Erenumab 140 mg
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Overall Number of Participants Analyzed 267 178 182
Least Squares Mean (95% Confidence Interval)
Unit of Measure: acute migraine treatment days / month
-1.58
(-2.05 to -1.11)
-3.45
(-4.02 to -2.87)
-4.13
(-4.70 to -3.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg
Comments Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.
Type of Statistical Test Superiority
Comments This comparison was tested at a 2-sided significance level of 0.04.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.86
Confidence Interval (2-Sided) 95%
-2.60 to -1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 140 mg
Comments Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.
Type of Statistical Test Superiority
Comments This comparison was tested at a 2-sided significance level of 0.01.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -2.55
Confidence Interval (2-Sided) 95%
-3.28 to -1.82
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Cumulative Monthly Headache Hours
Hide Description

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.
Time Frame 4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description

The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement.

The number of participants analyzed includes those with observed data at week 12.

Arm/Group Title Placebo Erenumab 70 mg Erenumab 140 mg
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Overall Number of Participants Analyzed 267 178 182
Least Squares Mean (95% Confidence Interval)
Unit of Measure: hours / month
-55.22
(-66.38 to -44.06)
-64.76
(-78.34 to -51.17)
-74.53
(-88.05 to -61.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg
Comments Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.
Type of Statistical Test Superiority
Comments This comparison was tested at a 2-sided significance level of 0.04.
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -9.54
Confidence Interval (2-Sided) 95%
-26.98 to 7.90
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 140 mg
Comments Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.
Type of Statistical Test Superiority
Comments This comparison was tested at a 2-sided significance level of 0.01.
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -19.31
Confidence Interval (2-Sided) 95%
-36.71 to -1.92
Estimation Comments [Not Specified]
5.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 the first dose of study drug up to 16 weeks after the last dose (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo Erenumab 70 mg Erenumab 140 mg
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Overall Number of Participants Analyzed 282 190 188
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
110
  39.0%
83
  43.7%
88
  46.8%
AEs grade ≥ 2
65
  23.0%
45
  23.7%
42
  22.3%
AEs grade ≥ 3
13
   4.6%
11
   5.8%
4
   2.1%
AEs grade ≥ 4
0
   0.0%
1
   0.5%
0
   0.0%
Serious adverse events
7
   2.5%
6
   3.2%
2
   1.1%
AEs leading to discontinuation of study drug
2
   0.7%
0
   0.0%
2
   1.1%
Fatal adverse events
0
   0.0%
0
   0.0%
0
   0.0%
6.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.

Time Frame Baseline and weeks 2, 4, 8, 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug and with available post-baseline antibody data. This endpoint was analyzed in the erenumab treatment groups only.
Arm/Group Title Placebo Erenumab 70 mg Erenumab 140 mg
Hide Arm/Group Description:
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Overall Number of Participants Analyzed 0 189 187
Measure Type: Count of Participants
Unit of Measure: Participants
Binding antibody positive
11
   5.8%
3
   1.6%
Neutralizing antibody positive
0
   0.0%
0
   0.0%
Time Frame From the first dose of study drug up to 16 weeks after the last dose (a total of 24 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 Placebo Erenumab 70 mg Erenumab 140 mg
Hide Arm/Group Description Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection. Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
All-Cause Mortality
Placebo Erenumab 70 mg Erenumab 140 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Erenumab 70 mg Erenumab 140 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/282 (2.48%)   6/190 (3.16%)   2/188 (1.06%) 
Gastrointestinal disorders       
Abdominal adhesions  1  0/282 (0.00%)  0/190 (0.00%)  1/188 (0.53%) 
Abdominal pain  1  0/282 (0.00%)  0/190 (0.00%)  1/188 (0.53%) 
Pancreatitis  1  1/282 (0.35%)  0/190 (0.00%)  0/188 (0.00%) 
Vomiting  1  1/282 (0.35%)  0/190 (0.00%)  0/188 (0.00%) 
General disorders       
Non-cardiac chest pain  1  0/282 (0.00%)  1/190 (0.53%)  0/188 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  1/282 (0.35%)  0/190 (0.00%)  0/188 (0.00%) 
Infections and infestations       
Appendicitis  1  0/282 (0.00%)  1/190 (0.53%)  0/188 (0.00%) 
Parotitis  1  1/282 (0.35%)  0/190 (0.00%)  0/188 (0.00%) 
Urinary tract infection  1  1/282 (0.35%)  0/190 (0.00%)  0/188 (0.00%) 
Injury, poisoning and procedural complications       
Cartilage injury  1  0/282 (0.00%)  0/190 (0.00%)  1/188 (0.53%) 
Radius fracture  1  0/282 (0.00%)  1/190 (0.53%)  0/188 (0.00%) 
Musculoskeletal and connective tissue disorders       
Costochondritis  1  0/282 (0.00%)  1/190 (0.53%)  0/188 (0.00%) 
Intervertebral disc protrusion  1  1/282 (0.35%)  1/190 (0.53%)  0/188 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Fibroma  1  0/282 (0.00%)  1/190 (0.53%)  0/188 (0.00%) 
Nervous system disorders       
Migraine  1  1/282 (0.35%)  0/190 (0.00%)  0/188 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Erenumab 70 mg Erenumab 140 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/282 (5.67%)   6/190 (3.16%)   3/188 (1.60%) 
Infections and infestations       
Nasopharyngitis  1  16/282 (5.67%)  6/190 (3.16%)  3/188 (1.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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: NCT02066415     History of Changes
Other Study ID Numbers: 20120295
2013-001707-36 ( EudraCT Number )
First Submitted: February 17, 2014
First Posted: February 19, 2014
Results First Submitted: May 21, 2018
Results First Posted: June 21, 2018
Last Update Posted: June 21, 2018