Migraine
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGErenumab
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
Sponsors
Danish Headache Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has provided informed consent prior to initiation of any study-specific activities/procedures * Age greater than or equal to 18 years upon entry into screening * History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self report * Greater than or equal to 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening after baseline period * Must have demonstrated greater than or equal to 75% compliance in headache diiary usage during baseline period
Exclusion criteria
Subjects are excluded from the study if any of the following criteria apply: Disease Related * Greater than 50 years of age at migraine onset * History of cluster headache or hemiplegic migraine headache * Inability to differentiate between migraine from other headaches * The subject is at risk of self-harm or harm to others as evidenced by past suicidal behaviour * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion Prior/Concomitant Therapy * Previously received erenumab (Aimovig®) * Received an anti-CGRP monoclonal antibody within 3 months prior to the start of the baseline period Prior/Concurrent Clinical Study Experience * Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study (ies). Other investigational procedures while participating in this study are excluded. Other Exclusions * Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test. * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product. * Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product. * Evidence of current pregnancy or breastfeeding per subject self-report or medical records * Subject has known sensitivity to any of the products or components to be administered during dosing * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Diary | Baseline Phase (Day -28 to Day 1) to Week 24 | Headache diary with daily entries to record migraine-related data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Semi-Structured Interview | Screening Visit (Day -28) | In-person semi-structured interview to record migraine-related data. |
| Headache Impact Test (HIT-6) | Baseline Phase (Day -28 to Day 1) to Week 24 | 6-item questionnaire to assess headache-related disability |
| Migraine Disability Assessment Test (MIDAS) | Baseline Phase (Day -28 to Day 1) to Week 24 | 7-item questionnaire to assess migraine-related disability |
| Hospital Anxiety and Depression Scale (HADS) | Baseline Phase (Day -28 to Day 1) to Week 24 | 14-item questionnaire to assess anxiety and depression |
| Headache Diary | Baseline Phase (Day -28 to Day 1) to Week 48 | Headache diary with daily entries to record migraine-related data. |
| 12-item Allodynia Symptom Checklist (ASC-12) | Baseline Phase (Day -28 to Day 1) to Week 24 | 12-item questionnaire to allodynia |
| WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) | Baseline Phase (Day -28 to Day 1) to Week 24 | Questionnaire to assess health status and disability |
| Neck Disability Index (NDI) | Baseline Phase (Day -28 to Day 1) to Week 24 | Questionnaire to assess neck disability |
| Low Back Pain Disability Questionnaire | Baseline Phase (Day -28 to Day 1) to Week 24 | Questionnaire to assess low back pain disability |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline Phase (Day -28 to Day 1) to Week 24 | 19-item questionnaire to assess quality of sleep |
Countries
Denmark
Contacts
Primary ContactMessoud Ashina, MD
Backup ContactFaisal Amin, MD
Outcome results
None listed