This study aims to investigate the effect of erenumab on efficacy outcomes, tolerability outcomes, and patient-reported outcomes in individuals with migraine. Furthermore, the study aims to identify clinical predictors of erenumab response.
Migraine is a prevalent neurological disorder and a leading cause of years lived with disability worldwide. As of recent, therapies targeting calcitonin gene-related peptide (e.g. erenumab) have been approved for the preventive treatment of migraine. This study aims to investigate the effect of erenumab on efficacy outcomes, tolerability outcomes, and patient-reported outcomes in individuals with migraine. Furthermore, the study aims to identify clinical predictors of erenumab response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
Danish Headache Center
Glostrup Municipality, Denmark
RECRUITINGHeadache Diary
Headache diary with daily entries to record migraine-related data.
Time frame: Baseline Phase (Day -28 to Day 1) to Week 24
Headache Diary
Headache diary with daily entries to record migraine-related data.
Time frame: Baseline Phase (Day -28 to Day 1) to Week 48
Semi-Structured Interview
In-person semi-structured interview to record migraine-related data.
Time frame: Screening Visit (Day -28)
Headache Impact Test (HIT-6)
6-item questionnaire to assess headache-related disability
Time frame: Baseline Phase (Day -28 to Day 1) to Week 24
Headache Impact Test (HIT-6)
6-item questionnaire to assess headache-related disability
Time frame: Baseline Phase (Day -28 to Day 1) to Week 48
Migraine Disability Assessment Test (MIDAS)
7-item questionnaire to assess migraine-related disability
Time frame: Baseline Phase (Day -28 to Day 1) to Week 24
Migraine Disability Assessment Test (MIDAS)
7-item questionnaire to assess migraine-related disability
Time frame: Baseline Phase (Day -28 to Day 1) to Week 48
Hospital Anxiety and Depression Scale (HADS)
14-item questionnaire to assess anxiety and depression
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Time frame: Baseline Phase (Day -28 to Day 1) to Week 24
Hospital Anxiety and Depression Scale (HADS)
14-item questionnaire to assess anxiety and depression
Time frame: Baseline Phase (Day -28 to Day 1) to Week 48
Pittsburgh Sleep Quality Index (PSQI)
19-item questionnaire to assess quality of sleep
Time frame: Baseline Phase (Day -28 to Day 1) to Week 24
Pittsburgh Sleep Quality Index (PSQI)
19-item questionnaire to assess quality of sleep
Time frame: Baseline Phase (Day -28 to Day 1) to Week 48
12-item Allodynia Symptom Checklist (ASC-12)
12-item questionnaire to allodynia
Time frame: Baseline Phase (Day -28 to Day 1) to Week 24
12-item Allodynia Symptom Checklist (ASC-12)
12-item questionnaire to allodynia
Time frame: Baseline Phase (Day -28 to Day 1) to Week 48
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Questionnaire to assess health status and disability
Time frame: Baseline Phase (Day -28 to Day 1) to Week 24
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Questionnaire to assess health status and disability
Time frame: Baseline Phase (Day -28 to Day 1) to Week 48
Neck Disability Index (NDI)
Questionnaire to assess neck disability
Time frame: Baseline Phase (Day -28 to Day 1) to Week 24
Neck Disability Index (NDI)
Questionnaire to assess neck disability
Time frame: Baseline Phase (Day -28 to Day 1) to Week 48
Low Back Pain Disability Questionnaire
Questionnaire to assess low back pain disability
Time frame: Baseline Phase (Day -28 to Day 1) to Week 24
Low Back Pain Disability Questionnaire
Questionnaire to assess low back pain disability
Time frame: Baseline Phase (Day -28 to Day 1) to Week 48