HER-MES: Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
Study Details
Study Description
Brief Summary
This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind, double-dummy design in adult patients with episodic migraine and chronic migraine, who had to be either naïve or not suitable for or could have failed up to three prophylactic treatments out of: propranolol/metoprolol, amitriptyline, flunarizine. Patients were stratified into groups according to their number of migraine days during the baseline period.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
All patients completing the Baseline period and fulfilling baseline eligibility criteria were invited to participate to the Double-blind, double-dummy Treatment Epoch (DBTE, 24 weeks) .
Eligible patients were randomized to one of two treatment arms. DBTE started with a titration phase for topiramate of a maximum of 6 weeks to determine the maximal tolerated dose and aimed to reach the recommended treatment dose of 100 mg according to the German SmPC. After the titration phase, maintenance phase started (18 weeks). Topiramate dose had to be maintained until the end of the DBTE. Erenumab dose at beginning of the DBTE was determined patient individually by the investigator based on the guidance provided in the SmPC and was either 70 mg or 140 mg. Dose escalation from 70 mg to 140 mg in case of insufficient response was considered at anytime during the DBTE.
Dose reduction of topiramate and erenumab was not allowed during DBTE (Week 0 to Week 24). After Week 24 or if the patient discontinued study drug, a one week double-blind taper off phase followed to ensure proper down titration for topiramate. At the end of the DBTE (24 weeks) the final assessment occurred to address the objectives.
A Follow-Up Visit 4 weeks after last study visit (or 8 weeks after last IMP injection for discontinued patients) was required as part of routine safety monitoring. The primary analysis was triggered when all patients had completed their respective last visit of the DBTE.
The End of study occurred when the last patient completed last visit (LPLV).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Erenumab 70 mg and 140 mg Erenumab |
Biological: Erenumab
70mg/1mL (70 mg) or 2x70mg/1mL (140 mg) in pre-filled syringe, administered every 4 weeks
Other Names:
Biological: Erenumab matching placebo
Erenumab matching placebo pre-filled syringue administered every 4 weeks
|
Active Comparator: Topiramate Topiramate in the highest tolerated dose (50 - 100 mg/day) |
Drug: Topiramate
Film-coated tablet taken orally:
25 mg administered once daily (first week of titration phase). After the first week, titration was done according to the summary of product characteristics (SmPC) in 25 mg increments each week and aimed to reach the recommended daily treatment dose of 100 mg (50/75/100 mg). 50/75/100 mg were administered twice daily during titration phase and maintenance phase.
Other Names:
Drug: Topiramate matching placebo
Topiramate matching placebo administered daily
|
Outcome Measures
Primary Outcome Measures
- Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE) [24 Weeks]
The primary objective was to demonstrate the tolerability of 70 mg and 140 mg erenumab compared to topiramate in the highest tolerated dose assessed by the rate of patients discontinuing treatment due to AE during the double-blind epoch of the study.
Secondary Outcome Measures
- Number of Patients With at Least 50% Reduction From Baseline in Monthly Migraine Days (MMD) Over the Last Three Months (Month 4, 5, and 6) [Baseline, Last three months (month 4, 5, and 6)]
The secondary objective of this study was to evaluate the effect of erenumab compared to topiramate on the proportion of patients with at least 50% reduction from baseline in MMDs. The Baseline period was defined as the period between Week -4 and the day prior to first dose. This was analyzed by logistic regression over the last 3 months (months 4, 5, and 6) of treatment. All the subjects' data collected regarding 50% response in MMD was used in the analysis regardless of whether subjects discontinue study treatment or not. Subjects with missing response information on this endpoint were imputed as non-response (non-responder imputation).
Other Outcome Measures
- EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Reduction in the Headache Impact Test (HIT-6) From Baseline to Week 24 [Baseline, Week 24]
The HIT-6 is a widely used patient-reported outcome measure that assesses the negative effects of headaches on normal activity. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social), wanting to lie down when headache is experienced, feeling too tired to work or do daily activities because of headache, feeling "fed up" or irritated because of headache, and headaches limiting ability to concentrate or work on daily activities. Each of the 6 questions is responded to using 1 of 5 response categories: "never," "rarely," "sometimes," "very often," or "always." For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points are summed to produce a total HIT-6 score that ranges from 36 to 78. HIT-6 scores are categorized into 4 grades: little or no impact (49 or less), some impact (50 - 55), substantial impact (56 - 59), and severe impact (60 - 78) due to headache.
- EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Increase in the Medical Outcome Short Form Health Survey Version 2 (SF-36) From Baseline to Week 24 [Baseline, Week 24]
The SF-36 is a widely used and extensively studied instrument to measure health-related quality of life (HRQoL) among healthy subjects and patients with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The SF-36 has proven useful in monitoring general and specific populations, comparing the relative burden of different disease, differentiating the health benefits produced by different treatments, and in screening individual patients. The purpose of the SF-36 in this study was to assess the HRQoL of patients. Given the nature of this disease and the 4-weekly assessment, the SF-36 version 2, with a 4-week recall period, was used in this study.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Documented history of migraine in the 12 months prior to screen
-
at least 4 days per month of migraine symptoms
-
=80% diary compliance during the Baseline period
-
Patients must be either naïve or not suitable or have failed previous migraine prophylactic treatments
Key Exclusion Criteria:
-
Older than 50 years of age at migraine onset
-
Pregnant or nursing
-
History of cluster or hemiplegic headache
-
History or evidence of major psychiatric disorder
-
Score of 19 or higher on Beck Depression Inventory (BDI)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis Investigative Site | Stuttgart | Baden Wuertemberg | Germany | 70178 |
2 | Novartis Investigative Site | Hannover | Niedersachsen | Germany | 30159 |
3 | Novartis Investigative Site | Aachen | Nordrhein-Westfalen | Germany | 52062 |
4 | Novartis Investigative Site | Alzenau | Germany | 63755 | |
5 | Novartis Investigative Site | Bad Homburg | Germany | 61348 | |
6 | Novartis Investigative Site | Bad Honnef | Germany | 53604 | |
7 | Novartis Investigative Site | Bad Saarow | Germany | 15526 | |
8 | Novartis Investigative Site | Bayreuth | Germany | 95445 | |
9 | Novartis Investigative Site | Bergen | Germany | 18528 | |
10 | Novartis Investigative Site | Berlin | Germany | 10713 | |
11 | Novartis Investigative Site | Berlin | Germany | 120999 | |
12 | Novartis Investigative Site | Berlin | Germany | 12101 | |
13 | Novartis Investigative Site | Berlin | Germany | 12163 | |
14 | Novartis Investigative Site | Berlin | Germany | 12627 | |
15 | Novartis Investigative Site | Berlin | Germany | 13156 | |
16 | Novartis Investigative Site | Berlin | Germany | 13353 | |
17 | Novartis Investigative Site | Berlin | Germany | 14169 | |
18 | Novartis Investigative Site | Bielefeld | Germany | D 33647 | |
19 | Novartis Investigative Site | Boblingen | Germany | 71032 | |
20 | Novartis Investigative Site | Bochum | Germany | 44791 | |
21 | Novartis Investigative Site | Bonn | Germany | 53111 | |
22 | Novartis Investigative Site | Bonn | Germany | 53177 | |
23 | Novartis Investigative Site | Celle | Germany | 29223 | |
24 | Novartis Investigative Site | Chemnitz | Germany | 09117 | |
25 | Novartis Investigative Site | Dillingen | Germany | 66763 | |
26 | Novartis Investigative Site | Erbach | Germany | 64711 | |
27 | Novartis Investigative Site | Essen | Germany | 45133 | |
28 | Novartis Investigative Site | Essen | Germany | 45147 | |
29 | Novartis Investigative Site | Frankfurt | Germany | 60313 | |
30 | Novartis Investigative Site | Freiburg | Germany | 79098 | |
31 | Novartis Investigative Site | Gelsenkirchen | Germany | 45879 | |
32 | Novartis Investigative Site | Greifswald | Germany | 17475 | |
33 | Novartis Investigative Site | Haar | Germany | 85540 | |
34 | Novartis Investigative Site | Halle | Germany | 06120 | |
35 | Novartis Investigative Site | Hamburg | Germany | 20253 | |
36 | Novartis Investigative Site | Heidelberg | Germany | 69120 | |
37 | Novartis Investigative Site | Heidenheim | Germany | 89518 | |
38 | Novartis Investigative Site | Hoppegarten | Germany | 15366 | |
39 | Novartis Investigative Site | Ibbenbueren | Germany | 49477 | |
40 | Novartis Investigative Site | Jena | Germany | 07740 | |
41 | Novartis Investigative Site | Juelich | Germany | 52428 | |
42 | Novartis Investigative Site | Kassel | Germany | 34121 | |
43 | Novartis Investigative Site | Kassel | Germany | ||
44 | Novartis Investigative Site | Kiel | Germany | 24149 | |
45 | Novartis Investigative Site | Koln | Germany | 50935 | |
46 | Novartis Investigative Site | Königstein im Taunus | Germany | 61462 | |
47 | Novartis Investigative Site | Leipzig | Germany | 04103 | |
48 | Novartis Investigative Site | Leipzig | Germany | 04107 | |
49 | Novartis Investigative Site | Luenen | Germany | 44534 | |
50 | Novartis Investigative Site | Mannheim | Germany | 66163 | |
51 | Novartis Investigative Site | Marburg Wehrda | Germany | 35041 | |
52 | Novartis Investigative Site | Mittweida | Germany | 09648 | |
53 | Novartis Investigative Site | Muenchen | Germany | 81377 | |
54 | Novartis Investigative Site | Muenchen | Germany | 81675 | |
55 | Novartis Investigative Site | Muenster | Germany | 48149 | |
56 | Novartis Investigative Site | Neu-Ulm | Germany | 89231 | |
57 | Novartis Investigative Site | Neuburg an der Donau | Germany | 86633 | |
58 | Novartis Investigative Site | Osnabrück | Germany | 49074 | |
59 | Novartis Investigative Site | Pforzheim | Germany | 75172 | |
60 | Novartis Investigative Site | Quakenbrueck | Germany | 49610 | |
61 | Novartis Investigative Site | Regensburg | Germany | 93059 | |
62 | Novartis Investigative Site | Rostock | Germany | 18057 | |
63 | Novartis Investigative Site | Ruelzheim | Germany | 76761 | |
64 | Novartis Investigative Site | Schwerin | Germany | 19053 | |
65 | Novartis Investigative Site | Schwerin | Germany | 19055 | |
66 | Novartis Investigative Site | Seesen | Germany | 38723 | |
67 | Novartis Investigative Site | Siegen | Germany | 57076 | |
68 | Novartis Investigative Site | Sindelfingen | Germany | 71065 | |
69 | Novartis Investigative Site | Stadtroda | Germany | 07646 | |
70 | Novartis Investigative Site | Stuttgart | Germany | 70174 | |
71 | Novartis Investigative Site | Stuttgart | Germany | 70178 | |
72 | Novartis Investigative Site | Stuttgart | Germany | 70182 | |
73 | Novartis Investigative Site | Trier | Germany | 54292 | |
74 | Novartis Investigative Site | Tübingen | Germany | 72076 | |
75 | Novartis Investigative Site | Ulm | Germany | 89073 | |
76 | Novartis Investigative Site | Unterhaching | Germany | 82008 | |
77 | Novartis Investigative Site | Westerstede/Oldenburg | Germany | 26655 | |
78 | Novartis Investigative Site | Wiesbaden | Germany | 65191 | |
79 | Novartis Investigative Site | Wuerzburg | Germany | 97080 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- CAMG334ADE01
- 2018-000943-15
Study Results
Participant Flow
Recruitment Details | 82 centers in Germany enrolled patients. |
---|---|
Pre-assignment Detail | A total of 777 patients were randomized to receive either erenumab (389 patients) or topiramate (388 patients). |
Arm/Group Title | Erenumab | Topiramate |
---|---|---|
Arm/Group Description | 70 mg and 140 mg Erenumab | Topiramate in the highest tolerated dose (50 - 100 mg/day) |
Period Title: Overall Study | ||
STARTED | 389 | 388 |
Full Analysis Set (FAS) | 388 | 388 |
Safety Analysis Set (SAF) | 388 | 388 |
COMPLETED | 373 | 366 |
NOT COMPLETED | 16 | 22 |
Baseline Characteristics
Arm/Group Title | Erenumab | Topiramate | Total |
---|---|---|---|
Arm/Group Description | 70 mg and 140 mg Erenumab | Topiramate in the highest tolerated dose (50 - 100 mg/day) | Total of all reporting groups |
Overall Participants | 388 | 388 | 776 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
40.8
(12.4)
|
40.7
(12.4)
|
40.7
(12.4)
|
Sex: Female, Male (Count of Participants) | |||
Female |
331
85.3%
|
335
86.3%
|
666
85.8%
|
Male |
57
14.7%
|
53
13.7%
|
110
14.2%
|
Race/Ethnicity, Customized (Number) [Number] | |||
Caucasian |
383
98.7%
|
387
99.7%
|
770
99.2%
|
Asian |
1
0.3%
|
0
0%
|
1
0.1%
|
Unknown |
1
0.3%
|
0
0%
|
1
0.1%
|
Other |
3
0.8%
|
1
0.3%
|
4
0.5%
|
Baseline Monthly Migraine Days (MMDs) categories (Count of Participants) | |||
< 4 days |
2
0.5%
|
0
0%
|
2
0.3%
|
4 to 7 days |
94
24.2%
|
92
23.7%
|
186
24%
|
8 to 14 days |
248
63.9%
|
254
65.5%
|
502
64.7%
|
>= 15 days |
43
11.1%
|
42
10.8%
|
85
11%
|
Missing |
1
0.3%
|
0
0%
|
1
0.1%
|
Outcome Measures
Title | Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE) |
---|---|
Description | The primary objective was to demonstrate the tolerability of 70 mg and 140 mg erenumab compared to topiramate in the highest tolerated dose assessed by the rate of patients discontinuing treatment due to AE during the double-blind epoch of the study. |
Time Frame | 24 Weeks |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS) |
Arm/Group Title | Erenumab | Topiramate |
---|---|---|
Arm/Group Description | 70 mg and 140 mg Erenumab | Topiramate in the highest tolerated dose (50 - 100 mg/day) |
Measure Participants | 388 | 388 |
Count of Participants [Participants] |
41
10.6%
|
151
38.9%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Erenumab, Topiramate |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <.001 |
Comments | ||
Method | Regression, Logistic | |
Comments | Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline) | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 0.19 | |
Confidence Interval |
(2-Sided) 95% 0.13 to 0.27 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Number of Patients With at Least 50% Reduction From Baseline in Monthly Migraine Days (MMD) Over the Last Three Months (Month 4, 5, and 6) |
---|---|
Description | The secondary objective of this study was to evaluate the effect of erenumab compared to topiramate on the proportion of patients with at least 50% reduction from baseline in MMDs. The Baseline period was defined as the period between Week -4 and the day prior to first dose. This was analyzed by logistic regression over the last 3 months (months 4, 5, and 6) of treatment. All the subjects' data collected regarding 50% response in MMD was used in the analysis regardless of whether subjects discontinue study treatment or not. Subjects with missing response information on this endpoint were imputed as non-response (non-responder imputation). |
Time Frame | Baseline, Last three months (month 4, 5, and 6) |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS) |
Arm/Group Title | Erenumab | Topiramate |
---|---|---|
Arm/Group Description | 70 mg and 140 mg Erenumab | Topiramate in the highest tolerated dose (50 - 100 mg/day) |
Measure Participants | 388 | 388 |
Count of Participants [Participants] |
215
55.4%
|
121
31.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Erenumab, Topiramate |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <.001 |
Comments | ||
Method | Regression, Logistic | |
Comments | Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline) | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 2.76 | |
Confidence Interval |
(2-Sided) 95% 2.06 to 3.71 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Reduction in the Headache Impact Test (HIT-6) From Baseline to Week 24 |
---|---|
Description | The HIT-6 is a widely used patient-reported outcome measure that assesses the negative effects of headaches on normal activity. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social), wanting to lie down when headache is experienced, feeling too tired to work or do daily activities because of headache, feeling "fed up" or irritated because of headache, and headaches limiting ability to concentrate or work on daily activities. Each of the 6 questions is responded to using 1 of 5 response categories: "never," "rarely," "sometimes," "very often," or "always." For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points are summed to produce a total HIT-6 score that ranges from 36 to 78. HIT-6 scores are categorized into 4 grades: little or no impact (49 or less), some impact (50 - 55), substantial impact (56 - 59), and severe impact (60 - 78) due to headache. |
Time Frame | Baseline, Week 24 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS) |
Arm/Group Title | Erenumab | Topiramate |
---|---|---|
Arm/Group Description | 70 mg and 140 mg Erenumab | Topiramate in the highest tolerated dose (50 - 100 mg/day) |
Measure Participants | 388 | 388 |
Count of Participants [Participants] |
280
72.2%
|
209
53.9%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Erenumab, Topiramate |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <.001 |
Comments | ||
Method | Regression, Logistic | |
Comments | Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline) | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 2.30 | |
Confidence Interval |
(2-Sided) 95% 1.70 to 3.12 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Increase in the Medical Outcome Short Form Health Survey Version 2 (SF-36) From Baseline to Week 24 |
---|---|
Description | The SF-36 is a widely used and extensively studied instrument to measure health-related quality of life (HRQoL) among healthy subjects and patients with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The SF-36 has proven useful in monitoring general and specific populations, comparing the relative burden of different disease, differentiating the health benefits produced by different treatments, and in screening individual patients. The purpose of the SF-36 in this study was to assess the HRQoL of patients. Given the nature of this disease and the 4-weekly assessment, the SF-36 version 2, with a 4-week recall period, was used in this study. |
Time Frame | Baseline, Week 24 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS) |
Arm/Group Title | Erenumab | Topiramate |
---|---|---|
Arm/Group Description | 70 mg and 140 mg Erenumab | Topiramate in the highest tolerated dose (50 - 100 mg/day) |
Measure Participants | 388 | 388 |
Physical Component Summary (PCS) |
185
47.7%
|
145
37.4%
|
Mental Component Summary (MCS) |
98
25.3%
|
65
16.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Erenumab, Topiramate |
---|---|---|
Comments | Physical Component Summary (PCS) | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Regression, Logistic | |
Comments | Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline) | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.75 | |
Confidence Interval |
(2-Sided) 95% 1.26 to 2.43 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Erenumab, Topiramate |
---|---|---|
Comments | Mental Component Summary (MCS) | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.005 |
Comments | ||
Method | Regression, Logistic | |
Comments | Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline) | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.79 | |
Confidence Interval |
(2-Sided) 95% 1.29 to 2.69 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | Adverse events were collected from first dose of study treatment until 8 weeks after the last Investigational Medicinal product (IMP) injection, assessed up to approximately 33 weeks (treatment duration ranged from 4.0 to 25.1 weeks). | |||
---|---|---|---|---|
Adverse Event Reporting Description | Any sign or symptom that occurs during the study treatment until 8 weeks after the last Investigational Medicinal product (IMP) injection. Maximum exposure to study treatments = 25 weeks (Erenumab treatment group) and 25.1 weeks (Topiramate treatment group). | |||
Arm/Group Title | Erenumab | Topiramate | ||
Arm/Group Description | 70 mg and 140 mg Erenumab | Topiramate in the highest tolerated dose (50 - 100 mg/day) | ||
All Cause Mortality |
||||
Erenumab | Topiramate | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/388 (0%) | 0/388 (0%) | ||
Serious Adverse Events |
||||
Erenumab | Topiramate | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 10/388 (2.6%) | 19/388 (4.9%) | ||
Eye disorders | ||||
Angle closure glaucoma | 0/388 (0%) | 1/388 (0.3%) | ||
Retinal detachment | 0/388 (0%) | 1/388 (0.3%) | ||
Rhegmatogenous retinal detachment | 0/388 (0%) | 1/388 (0.3%) | ||
Gastrointestinal disorders | ||||
Gastritis | 0/388 (0%) | 1/388 (0.3%) | ||
Irritable bowel syndrome | 0/388 (0%) | 1/388 (0.3%) | ||
Mechanical ileus | 1/388 (0.3%) | 0/388 (0%) | ||
Obstructive defaecation | 1/388 (0.3%) | 0/388 (0%) | ||
Hepatobiliary disorders | ||||
Cholelithiasis | 0/388 (0%) | 1/388 (0.3%) | ||
Immune system disorders | ||||
Anaphylactic shock | 0/388 (0%) | 1/388 (0.3%) | ||
Infections and infestations | ||||
Appendicitis | 0/388 (0%) | 1/388 (0.3%) | ||
Bacteriuria | 0/388 (0%) | 1/388 (0.3%) | ||
Gastroenteritis | 0/388 (0%) | 1/388 (0.3%) | ||
Gastrointestinal infection | 0/388 (0%) | 1/388 (0.3%) | ||
Influenza | 0/388 (0%) | 1/388 (0.3%) | ||
Nasopharyngitis | 0/388 (0%) | 1/388 (0.3%) | ||
Papilloma viral infection | 1/388 (0.3%) | 0/388 (0%) | ||
Parasitic gastroenteritis | 0/388 (0%) | 1/388 (0.3%) | ||
Pyelonephritis | 0/388 (0%) | 1/388 (0.3%) | ||
Injury, poisoning and procedural complications | ||||
Ankle fracture | 0/388 (0%) | 1/388 (0.3%) | ||
Concussion | 0/388 (0%) | 1/388 (0.3%) | ||
Contusion | 1/388 (0.3%) | 0/388 (0%) | ||
Fall | 1/388 (0.3%) | 0/388 (0%) | ||
Ligament rupture | 1/388 (0.3%) | 0/388 (0%) | ||
Limb injury | 1/388 (0.3%) | 0/388 (0%) | ||
Skin laceration | 1/388 (0.3%) | 0/388 (0%) | ||
Sternal fracture | 1/388 (0.3%) | 0/388 (0%) | ||
Tendon injury | 1/388 (0.3%) | 0/388 (0%) | ||
Investigations | ||||
Weight decreased | 0/388 (0%) | 1/388 (0.3%) | ||
Metabolism and nutrition disorders | ||||
Decreased appetite | 0/388 (0%) | 1/388 (0.3%) | ||
Musculoskeletal and connective tissue disorders | ||||
Intervertebral disc protrusion | 1/388 (0.3%) | 0/388 (0%) | ||
Lumbar spinal stenosis | 0/388 (0%) | 1/388 (0.3%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Fibroadenoma of breast | 0/388 (0%) | 1/388 (0.3%) | ||
Nervous system disorders | ||||
Migraine | 0/388 (0%) | 1/388 (0.3%) | ||
Migraine with aura | 1/388 (0.3%) | 0/388 (0%) | ||
Syncope | 0/388 (0%) | 1/388 (0.3%) | ||
Psychiatric disorders | ||||
Depression | 0/388 (0%) | 1/388 (0.3%) | ||
Major depression | 1/388 (0.3%) | 0/388 (0%) | ||
Reproductive system and breast disorders | ||||
Cervical dysplasia | 1/388 (0.3%) | 0/388 (0%) | ||
Dysmenorrhoea | 1/388 (0.3%) | 0/388 (0%) | ||
Endometriosis | 0/388 (0%) | 1/388 (0.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
Erenumab | Topiramate | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 253/388 (65.2%) | 331/388 (85.3%) | ||
Ear and labyrinth disorders | ||||
Vertigo | 20/388 (5.2%) | 24/388 (6.2%) | ||
Gastrointestinal disorders | ||||
Abdominal pain upper | 22/388 (5.7%) | 23/388 (5.9%) | ||
Constipation | 48/388 (12.4%) | 12/388 (3.1%) | ||
Diarrhoea | 20/388 (5.2%) | 29/388 (7.5%) | ||
Nausea | 36/388 (9.3%) | 71/388 (18.3%) | ||
General disorders | ||||
Fatigue | 44/388 (11.3%) | 74/388 (19.1%) | ||
Infections and infestations | ||||
Nasopharyngitis | 145/388 (37.4%) | 150/388 (38.7%) | ||
Investigations | ||||
Weight decreased | 5/388 (1.3%) | 22/388 (5.7%) | ||
Metabolism and nutrition disorders | ||||
Decreased appetite | 8/388 (2.1%) | 39/388 (10.1%) | ||
Musculoskeletal and connective tissue disorders | ||||
Back pain | 21/388 (5.4%) | 20/388 (5.2%) | ||
Nervous system disorders | ||||
Disturbance in attention | 18/388 (4.6%) | 63/388 (16.2%) | ||
Dizziness | 28/388 (7.2%) | 60/388 (15.5%) | ||
Dysgeusia | 3/388 (0.8%) | 23/388 (5.9%) | ||
Paraesthesia | 17/388 (4.4%) | 159/388 (41%) | ||
Taste disorder | 0/388 (0%) | 26/388 (6.7%) | ||
Psychiatric disorders | ||||
Sleep disorder | 20/388 (5.2%) | 8/388 (2.1%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title | Study Director |
---|---|
Organization | Novartis Pharmaceuticals |
Phone | 862-778-8300 |
Novartis.email@novartis.com |
- CAMG334ADE01
- 2018-000943-15