Registry for Migraine - Clinical Core (REFORM)

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 Overview

• Status: Unknown
• Conditions: Migraine
• Intervention / Treatment: Drug: Erenumab

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Recruiting
    • Danish Headache Center
    • Contact: Messoud Ashina, MD; Phone Number: +45 38 63 33 85; Email: ashina@dadlnet.dk
    • Contact: Faisal Amin, MD; Phone Number: +4538633186; Email: amin.faisal@hotmail.com
    • Principal Investigator: Messoud Ashina, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-Arm; Erenumab packed in a SureClick® Autoinjector Pen (AI)	Drug: Erenumab; Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI); Other Names: Aimovig

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Diary	Headache diary with daily entries to record migraine-related data.	Baseline Phase (Day -28 to Day 1) to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Diary	Headache diary with daily entries to record migraine-related data.	Baseline Phase (Day -28 to Day 1) to Week 48
Semi-Structured Interview	In-person semi-structured interview to record migraine-related data.	Screening Visit (Day -28)
Headache Impact Test (HIT-6)	6-item questionnaire to assess headache-related disability	Baseline Phase (Day -28 to Day 1) to Week 24
Headache Impact Test (HIT-6)	6-item questionnaire to assess headache-related disability	Baseline Phase (Day -28 to Day 1) to Week 48
Migraine Disability Assessment Test (MIDAS)	7-item questionnaire to assess migraine-related disability	Baseline Phase (Day -28 to Day 1) to Week 24
Migraine Disability Assessment Test (MIDAS)	7-item questionnaire to assess migraine-related disability	Baseline Phase (Day -28 to Day 1) to Week 48
Hospital Anxiety and Depression Scale (HADS)	14-item questionnaire to assess anxiety and depression	Baseline Phase (Day -28 to Day 1) to Week 24
Hospital Anxiety and Depression Scale (HADS)	14-item questionnaire to assess anxiety and depression	Baseline Phase (Day -28 to Day 1) to Week 48
Pittsburgh Sleep Quality Index (PSQI)	19-item questionnaire to assess quality of sleep	Baseline Phase (Day -28 to Day 1) to Week 24
Pittsburgh Sleep Quality Index (PSQI)	19-item questionnaire to assess quality of sleep	Baseline Phase (Day -28 to Day 1) to Week 48
12-item Allodynia Symptom Checklist (ASC-12)	12-item questionnaire to allodynia	Baseline Phase (Day -28 to Day 1) to Week 24
12-item Allodynia Symptom Checklist (ASC-12)	12-item questionnaire to allodynia	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	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	Baseline Phase (Day -28 to Day 1) to Week 48
Neck Disability Index (NDI)	Questionnaire to assess neck disability	Baseline Phase (Day -28 to Day 1) to Week 24
Neck Disability Index (NDI)	Questionnaire to assess neck disability	Baseline Phase (Day -28 to Day 1) to Week 48
Low Back Pain Disability Questionnaire	Questionnaire to assess low back pain disability	Baseline Phase (Day -28 to Day 1) to Week 24
Low Back Pain Disability Questionnaire	Questionnaire to assess low back pain disability	Baseline Phase (Day -28 to Day 1) to Week 48

Collaborators and Investigators

• Sponsor: Danish Headache Center

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Calcitonin Gene-Related Peptide Receptor Antagonists; Erenumab
• Other Study ID Numbers: 20019411

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No