REFORM: Registry for Migraine - Clinical Core
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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 Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- 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
- 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 24]
6-item questionnaire to assess headache-related disability
- 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 24]
7-item questionnaire to assess migraine-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 24]
14-item questionnaire to assess anxiety and depression
- 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 24]
19-item questionnaire to assess quality of sleep
- 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 24]
12-item questionnaire to allodynia
- 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 24]
Questionnaire to assess health status and disability
- 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 24]
Questionnaire to assess neck 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 24]
Questionnaire to assess low back pain disability
- Low Back Pain Disability Questionnaire [Baseline Phase (Day -28 to Day 1) to Week 48]
Questionnaire to assess low back pain disability
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Danish Headache Center | Glostrup | Denmark | 2600 |
Sponsors and Collaborators
- Danish Headache Center
Investigators
- Principal Investigator: Messoud Ashina, MD, Danish Headache Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20019411