Registry for Migraine - Clinical Core (REFORM)

Danish Headache Center

Status and phase

Unknown

Phase 4

Conditions

Migraine

Treatments

Drug: Erenumab

Study type

Interventional

Funder types

Other

Identifiers

NCT04603976

20019411

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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