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    Clinical Trial Results:
    Head-to-head study of Erenumab against topiRamate-a double-blind, double dummy Migraine study to assess tolerability and efficacy in a patiEnt –centered Setting

    Summary
    EudraCT number
    		 2018-000943-15
    Trial protocol
    		 DE  
    Global end of trial date
    29 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2021
    First version publication date
    04 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAMG334ADE01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03828539
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jul 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 776
    Worldwide total number of subjects
    776
    EEA total number of subjects
    776
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    772
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 82 centers in Germany enrolled patients.

    Pre-assignment
    Screening details
    		 A total of 777 patients were randomized to receive either erenumab (389 patients) or topiramate (388 patients).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Erenumab
    Arm description
    		 70 mg and 140 mg Erenumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Erenumab
    Investigational medicinal product code
    Other name
    AMG334
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    70mg/1mL (70 mg) or 2x70mg/1mL (140 mg) in pre-filled syringe, administered every 4 weeks

    Investigational medicinal product name
    Erenumab matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Erenumab matching placebo pre-filled syringue administered every 4 weeks

    Arm title
    		 Topiramate
    Arm description
    		 Topiramate in the highest tolerated dose (50 - 100 mg/day)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Topiramate matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Topiramate matching placebo administered daily

    Investigational medicinal product name
    Topiramate
    Investigational medicinal product code
    Other name
    Topamax
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    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.

    Number of subjects in period 1
    		Erenumab Topiramate
    Started
    388
    388
    Full Analysis set (FAS)
    388
    388
    Safety Analysis Set (SAF)
    388
    388
    Completed
    372
    366
    Not completed
    16
    22
         Adverse event, non-fatal
    3
    12
         Patient’s/guardian’s decision
    3
    5
         Lost to follow-up
    4
    2
         Withdrawal of informed consent
    2
    1
         New therapy for study indication
    1
    -
         Protocol deviation
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Erenumab
    Reporting group description
    		 70 mg and 140 mg Erenumab

    Reporting group title
    Topiramate
    Reporting group description
    		 Topiramate in the highest tolerated dose (50 - 100 mg/day)

    Reporting group values
    		 Erenumab Topiramate Total
    Number of subjects
    		 388 388 776
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 385 387 772
        From 65-84 years
    		 3 1 4
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 40.8 ± 12.4 40.7 ± 12.4 -
    Sex: Female, Male
    Units: Participants
        Female
    		 331 335 666
        Male
    		 57 53 110
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 383 387 770
        Asian
    		 1 0 1
        Unknown
    		 1 0 1
        Other
    		 3 1 4
    Baseline Monthly Migraine Days (MMDs) categories
    Monthly migraine days at baseline are the number of migraine days in the baseline period that are normalized in a 28-day interval. Monthly migraine days after baseline are the number of migraine days between each monthly IMP dose that are normalized in a 28-day interval. Days without eDiary data in each normalized monthly interval were prorated.
    Units: Subjects
        < 4 days
    		 2 0 2
        4 to 7 days
    		 94 92 186
        8 to 14 days
    		 248 254 502
        >= 15 days
    		 43 42 85
        Missing
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Erenumab
    Reporting group description
    		 70 mg and 140 mg Erenumab

    Reporting group title
    Topiramate
    Reporting group description
    		 Topiramate in the highest tolerated dose (50 - 100 mg/day)

    Primary: Proportion of patients with treatment discontinuation due to an Adverse Event (AE) during the double-blind treatment epoch/period (DBTE)

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    End point title
    		 Proportion of patients with treatment discontinuation due to an Adverse Event (AE) during the double-blind treatment epoch/period (DBTE)
    End point 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.
    End point type
    Primary
    End point timeframe
    24 Weeks
    End point values
    		 Erenumab Topiramate
    Number of subjects analysed
    388
    388
    Units: Participants
    41
    151
    Statistical analysis title
    		 Treatment discontinuation due to an AE during DBTE
    Comparison groups
    Erenumab v Topiramate
    Number of subjects included in analysis
    776
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 0.27

    Secondary: 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)

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    End point 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)
    End point 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).
    End point type
    Secondary
    End point timeframe
    Baseline, Last three months (month 4, 5, and 6)
    End point values
    		 Erenumab Topiramate
    Number of subjects analysed
    388
    388
    Units: Participants
    215
    121
    Statistical analysis title
    		 Reduction in MMDs over the last three months
    Comparison groups
    Erenumab v Topiramate
    Number of subjects included in analysis
    776
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.06
         upper limit
    		 3.71

    Other pre-specified: EXPLORATORY ENDPOINT: Proportion of patients achieving at least a 5 points reduction in the Headache Impact Test (HIT-6) from baseline to week 24

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    End point 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
    End point 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.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 24
    End point values
    		 Erenumab Topiramate
    Number of subjects analysed
    388
    388
    Units: Participants
    280
    209
    Statistical analysis title
    		 5 points reduction in HIT-6 from BL to Week 24
    Comparison groups
    Erenumab v Topiramate
    Number of subjects included in analysis
    776
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 3.12

    Other pre-specified: 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

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    End point 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
    End point 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.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 24
    End point values
    		 Erenumab Topiramate
    Number of subjects analysed
    388
    388
    Units: Participants
        Physical Component Summary (PCS)
    185
    145
        Mental Component Summary (MCS)
    98
    65
    Statistical analysis title
    		 5 points increase in SF-36 from BL to Week 24
    Statistical analysis description
    Physical Component Summary (PCS)
    Comparison groups
    Erenumab v Topiramate
    Number of subjects included in analysis
    776
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.26
         upper limit
    		 2.43
    Statistical analysis title
    		 5 points increase in SF-36 from BL to Week 24
    Statistical analysis description
    Mental Component Summary (MCS)
    Comparison groups
    Erenumab v Topiramate
    Number of subjects included in analysis
    776
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.005
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 2.69

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Erenumab
    Reporting group description
    		 Erenumab

    Reporting group title
    Topiramate
    Reporting group description
    		 Topiramate

    Serious adverse events
    		 Erenumab Topiramate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 388 (2.58%)
    19 / 388 (4.90%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Weight decreased
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine with aura
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Angle closure glaucoma
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhegmatogenous retinal detachment
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive defaecation
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteriuria
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papilloma viral infection
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 388 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parasitic gastroenteritis
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 388 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Erenumab Topiramate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    253 / 388 (65.21%)
    331 / 388 (85.31%)
    Investigations
    Weight decreased
         subjects affected / exposed
    5 / 388 (1.29%)
    22 / 388 (5.67%)
         occurrences all number
    5
    23
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    18 / 388 (4.64%)
    63 / 388 (16.24%)
         occurrences all number
    19
    65
    Dizziness
         subjects affected / exposed
    28 / 388 (7.22%)
    60 / 388 (15.46%)
         occurrences all number
    31
    66
    Dysgeusia
         subjects affected / exposed
    3 / 388 (0.77%)
    23 / 388 (5.93%)
         occurrences all number
    3
    23
    Paraesthesia
         subjects affected / exposed
    17 / 388 (4.38%)
    159 / 388 (40.98%)
         occurrences all number
    22
    196
    Taste disorder
         subjects affected / exposed
    0 / 388 (0.00%)
    26 / 388 (6.70%)
         occurrences all number
    0
    26
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    44 / 388 (11.34%)
    74 / 388 (19.07%)
         occurrences all number
    48
    87
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    20 / 388 (5.15%)
    24 / 388 (6.19%)
         occurrences all number
    24
    28
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    22 / 388 (5.67%)
    23 / 388 (5.93%)
         occurrences all number
    25
    23
    Constipation
         subjects affected / exposed
    48 / 388 (12.37%)
    12 / 388 (3.09%)
         occurrences all number
    50
    12
    Diarrhoea
         subjects affected / exposed
    20 / 388 (5.15%)
    29 / 388 (7.47%)
         occurrences all number
    21
    30
    Nausea
         subjects affected / exposed
    36 / 388 (9.28%)
    71 / 388 (18.30%)
         occurrences all number
    44
    75
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    20 / 388 (5.15%)
    8 / 388 (2.06%)
         occurrences all number
    21
    9
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    21 / 388 (5.41%)
    20 / 388 (5.15%)
         occurrences all number
    23
    20
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    145 / 388 (37.37%)
    150 / 388 (38.66%)
         occurrences all number
    189
    197
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 388 (2.06%)
    39 / 388 (10.05%)
         occurrences all number
    8
    40

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2019
    Amendment 01: Implementation of further safety procedures in line with topiramate SmPC, adjustment of safety follow-up, correction and clarification of certain criteria and procedures.
    06 Jun 2019
    Amendment 02: Inclusion of patients with chronic migraine, correction and clarification of certain criteria and procedures.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    1 patient in the erenumab treatment group was mis-randomized (no intake of active study medication) and was excluded from all analysis.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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