Registry for Migraine - Clinical Core
- Registration Number
- NCT04603976
- Lead Sponsor
- Danish Headache Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-Arm Erenumab Erenumab packed in a SureClick® Autoinjector Pen (AI)
- Primary Outcome Measures
Name Time Method Headache Diary Baseline Phase (Day -28 to Day 1) to Week 24 Headache diary with daily entries to record migraine-related data.
- Secondary Outcome Measures
Name Time Method Headache Diary Baseline Phase (Day -28 to Day 1) to Week 48 Headache diary with daily entries to record migraine-related data.
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 48 6-item questionnaire to assess headache-related disability
Migraine Disability Assessment Test (MIDAS) Baseline Phase (Day -28 to Day 1) to Week 48 7-item questionnaire to assess migraine-related disability
Hospital Anxiety and Depression Scale (HADS) Baseline Phase (Day -28 to Day 1) to Week 48 14-item questionnaire to assess anxiety and depression
Pittsburgh Sleep Quality Index (PSQI) Baseline Phase (Day -28 to Day 1) to Week 48 19-item questionnaire to assess quality of sleep
12-item Allodynia Symptom Checklist (ASC-12) Baseline Phase (Day -28 to Day 1) to Week 48 12-item questionnaire to allodynia
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) Baseline Phase (Day -28 to Day 1) to Week 48 Questionnaire to assess health status and disability
Neck Disability Index (NDI) Baseline Phase (Day -28 to Day 1) to Week 48 Questionnaire to assess neck disability
Low Back Pain Disability Questionnaire Baseline Phase (Day -28 to Day 1) to Week 48 Questionnaire to assess low back pain disability
Trial Locations
- Locations (1)
Danish Headache Center
🇩🇰Glostrup, Denmark