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Trial record 21 of 1110 for:    migraine

A Safety and Efficacy Study to Evaluate AMG 334 in 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: NCT02630459
Recruitment Status : Completed
First Posted : December 15, 2015
Results First Posted : March 13, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Migraine
Interventions Drug: Placebo
Drug: Erenumab
Enrollment 475
Recruitment Details The study was initiated on 06 January 2016 at 43 centers in Japan and consists of a 24-week double-blind treatment phase followed by a 76-week open-label treatment phase. Results are reported for the analysis of the 24-week double-blind treatment phase.
Pre-assignment Details Adult participants with episodic migraine were randomized 2:1:2:2 to receive placebo, erenumab 28 milligram (mg), erenumab 70 mg, or erenumab 140 mg once monthly (QM). Randomization was stratified by prior/current treatment with migraine prophylactic medication status (current, prior only, or no prior/current treatment).
Arm/Group Title Placebo Erenumab 28 mg QM Erenumab 70 mg QM Erenumab 140 mg QM
Hide Arm/Group Description Participants received placebo by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. Participants received erenumab 28 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. Participants received erenumab 70 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. Participants received erenumab 140 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Period Title: Overall Study
Started 136 67 135 137
Received Investigational Product 136 66 135 137
Completed [1] 133 65 130 134
Not Completed 3 2 5 3
Reason Not Completed
Protocol-specified criteria             0             1             0             2
Sponsor decision             0             0             1             0
Withdrawal by Subject             2             1             4             1
Subject missed week 24 assessment             1             0             0             0
[1]
Completed week 24 assessment of double-blind treatment phase.
Arm/Group Title Placebo Erenumab 28 mg QM Erenumab 70 mg QM Erenumab 140 mg QM Total
Hide Arm/Group Description Participants received placebo by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. Participants received erenumab 28 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. Participants received erenumab 70 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. Participants received erenumab 140 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. Total of all reporting groups
Overall Number of Baseline Participants 136 67 135 137 475
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 136 participants 67 participants 135 participants 137 participants 475 participants
43.7  (9.1) 42.8  (6.9) 43.8  (9.0) 45.0  (8.3) 44.0  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 67 participants 135 participants 137 participants 475 participants
Female
118
  86.8%
55
  82.1%
115
  85.2%
112
  81.8%
400
  84.2%
Male
18
  13.2%
12
  17.9%
20
  14.8%
25
  18.2%
75
  15.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 67 participants 135 participants 137 participants 475 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
136
 100.0%
67
 100.0%
135
 100.0%
137
 100.0%
475
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 67 participants 135 participants 137 participants 475 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
136
 100.0%
67
 100.0%
135
 100.0%
137
 100.0%
475
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Monthly Migraine Days at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 136 participants 67 participants 135 participants 137 participants 475 participants
7.67  (2.34) 7.68  (2.14) 7.84  (2.31) 8.14  (2.43) 7.86  (2.33)
[1]
Measure Description: The number of migraine days in the 4-week baseline period. A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥ 30 minutes and meeting at least one of the pre-specified pain features and/or associated symptoms criteria.
Treatment Status with Migraine Prophylactic Medication   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 67 participants 135 participants 137 participants 475 participants
Current treatment
14
  10.3%
7
  10.4%
13
   9.6%
15
  10.9%
49
  10.3%
Prior treatment only
75
  55.1%
38
  56.7%
75
  55.6%
75
  54.7%
263
  55.4%
No prior or current treatment
47
  34.6%
22
  32.8%
47
  34.8%
47
  34.3%
163
  34.3%
[1]
Measure Description: Treatment status values presented are those utilized in the randomization process.
1.Primary Outcome
Title Change From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6
Hide Description A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: a) ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity; b) ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia. Change from baseline was calculated using the mean monthly migraine days from months 4, 5 and 6 of the double-blind treatment phase minus the number of migraine days during the 4-week baseline phase. Least squares (LS) mean was estimated using a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (current, prior only, or no prior/current treatment), and baseline value as covariates.
Time Frame 4-week baseline phase and months 4, 5 and 6 of double-blind treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of the investigational product and had at least 1 change from baseline measurement in monthly migraine days during the double-blind treatment phase (Efficacy Analysis Set).
Arm/Group Title Placebo Erenumab 28 mg QM Erenumab 70 mg QM Erenumab 140 mg QM
Hide Arm/Group Description:
Participants received placebo by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Participants received erenumab 28 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Participants received erenumab 70 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Participants received erenumab 140 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Overall Number of Participants Analyzed 136 66 135 136
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Days
0.06
(-0.46 to 0.58)
-1.19
(-1.91 to -0.47)
-2.25
(-2.78 to -1.73)
-1.83
(-2.35 to -1.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 140 mg QM
Comments The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure
Type of Statistical Test Superiority
Comments To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons were nominal and without multiplicity adjustment.
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.89
Confidence Interval (2-Sided) 95%
-2.58 to -1.20
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg QM
Comments The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure
Type of Statistical Test Superiority
Comments To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons were nominal and without multiplicity adjustment.
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.31
Confidence Interval (2-Sided) 95%
-3.00 to -1.62
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 28 mg QM
Comments The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure
Type of Statistical Test Superiority
Comments To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.
Statistical Test of Hypothesis P-Value 0.004
Comments P-values for pairwise comparisons were nominal and without multiplicity adjustment.
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.25
Confidence Interval (2-Sided) 95%
-2.10 to -0.41
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With at Least a 50% Reduction From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6
Hide Description

A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: a) ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity; b) ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia.

At least a 50% reduction from baseline in monthly migraine days was determined if; (mean monthly migraine days over the last three months of the double-blind treatment phase minus baseline monthly migraine days) * 100 / baseline monthly migraine days, was less than or equal to -50%.

Time Frame 4-week baseline phase and months 4, 5 and 6 of double-blind treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of the investigational product and had at least 1 change from baseline measurement in monthly migraine days during the double-blind treatment phase (Efficacy Analysis Set).
Arm/Group Title Placebo Erenumab 28 mg QM Erenumab 70 mg QM Erenumab 140 mg QM
Hide Arm/Group Description:
Participants received placebo by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Participants received erenumab 28 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Participants received erenumab 70 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Participants received erenumab 140 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Overall Number of Participants Analyzed 136 66 135 136
Measure Type: Number
Unit of Measure: Percentage of participants
7.4 19.7 28.9 27.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 140 mg QM
Comments The common odds ratios and p-values were obtained from a Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Common Odds Ratio
Estimated Value 4.73
Confidence Interval (2-Sided) 95%
2.24 to 9.99
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg QM
Comments The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Common Odds Ratio
Estimated Value 5.60
Confidence Interval (2-Sided) 95%
2.60 to 12.06
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 28 mg QM
Comments The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Common Odds Ratio
Estimated Value 3.21
Confidence Interval (2-Sided) 95%
1.30 to 7.88
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Mean Monthly Acute Migraine-Specific Medication Treatment Days at Months 4, 5 and 6
Time Frame 4-week baseline phase and months 4, 5 and 6 of double-blind treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of the investigational product and had at least 1 change from baseline measurement in acute migraine-specific medication treatment days during the double-blind treatment phase (Efficacy Analysis Set).
Arm/Group Title Placebo Erenumab 28 mg QM Erenumab 70 mg QM Erenumab 140 mg QM
Hide Arm/Group Description:
Participants received placebo by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Participants received erenumab 28 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Participants received erenumab 70 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Participants received erenumab 140 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
Overall Number of Participants Analyzed 136 66 135 136
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Days
0.88
(0.44 to 1.33)
-0.19
(-0.80 to 0.43)
-1.19
(-1.64 to -0.74)
-1.16
(-1.60 to -0.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 140 mg QM
Comments The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure
Type of Statistical Test Superiority
Comments To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons were nominal and without multiplicity adjustment.
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.04
Confidence Interval (2-Sided) 95%
-2.63 to -1.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 70 mg QM
Comments The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure
Type of Statistical Test Superiority
Comments To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.
Statistical Test of Hypothesis P-Value <0.001
Comments P-values for pairwise comparisons were nominal and without multiplicity adjustment.
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.07
Confidence Interval (2-Sided) 95%
-2.66 to -1.49
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Erenumab 28 mg QM
Comments The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure
Type of Statistical Test Superiority
Comments To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.
Statistical Test of Hypothesis P-Value 0.004
Comments P-values for pairwise comparisons were nominal and without multiplicity adjustment.
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.07
Confidence Interval (2-Sided) 95%
-1.80 to -0.35
Estimation Comments [Not Specified]
Time Frame Adverse events are reported for the 24 week double-blind treatment phase (i.e. from first dose of investigational product in the double-blind treatment phase until the first dose of investigational product in the open-label treatment phase). For participants who did not enter the ongoing open-label treatment phase, adverse events during safety follow-up were reported up to 16 weeks after the last dose in the double-blind treatment phase.
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 28 mg QM Erenumab 70 mg QM Erenumab 140 mg QM
Hide Arm/Group Description Participants received placebo by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. Participants received erenumab 28 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. Participants received erenumab 70 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. Participants received erenumab 140 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase.
All-Cause Mortality
Placebo Erenumab 28 mg QM Erenumab 70 mg QM Erenumab 140 mg QM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/136 (0.00%)   0/66 (0.00%)   0/135 (0.00%)   0/137 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Erenumab 28 mg QM Erenumab 70 mg QM Erenumab 140 mg QM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/136 (2.94%)   1/66 (1.52%)   1/135 (0.74%)   1/137 (0.73%) 
Cardiac disorders         
Prinzmetal angina  1  1/136 (0.74%)  0/66 (0.00%)  0/135 (0.00%)  0/137 (0.00%) 
Gastrointestinal disorders         
Haemorrhoids  1  1/136 (0.74%)  0/66 (0.00%)  0/135 (0.00%)  0/137 (0.00%) 
Infections and infestations         
Gastroenteritis  1  0/136 (0.00%)  0/66 (0.00%)  0/135 (0.00%)  1/137 (0.73%) 
Intestinal tuberculosis  1  0/136 (0.00%)  0/66 (0.00%)  0/135 (0.00%)  1/137 (0.73%) 
Injury, poisoning and procedural complications         
Hand fracture  1  0/136 (0.00%)  1/66 (1.52%)  0/135 (0.00%)  0/137 (0.00%) 
Musculoskeletal and connective tissue disorders         
Systemic lupus erythematosus  1  0/136 (0.00%)  0/66 (0.00%)  1/135 (0.74%)  0/137 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Renal cell carcinoma  1  1/136 (0.74%)  0/66 (0.00%)  0/135 (0.00%)  0/137 (0.00%) 
Nervous system disorders         
Migraine  1  1/136 (0.74%)  0/66 (0.00%)  0/135 (0.00%)  0/137 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo Erenumab 28 mg QM Erenumab 70 mg QM Erenumab 140 mg QM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54/136 (39.71%)   32/66 (48.48%)   64/135 (47.41%)   58/137 (42.34%) 
Gastrointestinal disorders         
Abdominal pain upper  1  1/136 (0.74%)  1/66 (1.52%)  5/135 (3.70%)  2/137 (1.46%) 
Constipation  1  2/136 (1.47%)  0/66 (0.00%)  6/135 (4.44%)  7/137 (5.11%) 
Dental caries  1  3/136 (2.21%)  2/66 (3.03%)  6/135 (4.44%)  2/137 (1.46%) 
Stomatitis  1  1/136 (0.74%)  2/66 (3.03%)  1/135 (0.74%)  1/137 (0.73%) 
General disorders         
Injection site pain  1  1/136 (0.74%)  2/66 (3.03%)  0/135 (0.00%)  0/137 (0.00%) 
Infections and infestations         
Gastroenteritis  1  4/136 (2.94%)  2/66 (3.03%)  2/135 (1.48%)  4/137 (2.92%) 
Gingivitis  1  0/136 (0.00%)  2/66 (3.03%)  1/135 (0.74%)  0/137 (0.00%) 
Nasopharyngitis  1  40/136 (29.41%)  22/66 (33.33%)  39/135 (28.89%)  45/137 (32.85%) 
Pharyngitis  1  3/136 (2.21%)  3/66 (4.55%)  5/135 (3.70%)  3/137 (2.19%) 
Tinea pedis  1  0/136 (0.00%)  2/66 (3.03%)  0/135 (0.00%)  1/137 (0.73%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  2/136 (1.47%)  3/66 (4.55%)  7/135 (5.19%)  1/137 (0.73%) 
Nervous system disorders         
Headache  1  5/136 (3.68%)  0/66 (0.00%)  1/135 (0.74%)  1/137 (0.73%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
This study has an open-label treatment phase that is ongoing. Final study results will be updated after the trial is completed.
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
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Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02630459     History of Changes
Other Study ID Numbers: 20120309
First Submitted: December 11, 2015
First Posted: December 15, 2015
Results First Submitted: September 17, 2018
Results First Posted: March 13, 2019
Last Update Posted: July 1, 2019