Clinical trial NCT04603976: Registry for Migraine - Clinical Core
Official title: Registry for Migraine - Clinical Core
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Headache Diary
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 24
Secondary outcomes:
measure: Headache Diary
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 48
measure: Semi-Structured Interview
timeFrame: Screening Visit (Day -28)
measure: Headache Impact Test (HIT-6)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 24
measure: Headache Impact Test (HIT-6)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 48
measure: Migraine Disability Assessment Test (MIDAS)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 24
measure: Migraine Disability Assessment Test (MIDAS)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 48
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 24
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 48
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 24
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 48
measure: 12-item Allodynia Symptom Checklist (ASC-12)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 24
measure: 12-item Allodynia Symptom Checklist (ASC-12)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 48
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 24
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 48
measure: Neck Disability Index (NDI)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 24
measure: Neck Disability Index (NDI)
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 48
measure: Low Back Pain Disability Questionnaire
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 24
measure: Low Back Pain Disability Questionnaire
timeFrame: Baseline Phase (Day -28 to Day 1) to Week 48
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina, MD
role: PRINCIPAL_INVESTIGATOR
References: