Registry for Migraine - Clinical Core

Migraine Clinical Trial

— REFORM  

Official title:

Registry for Migraine - Clinical Core

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04603976
• Other study ID #: 20019411
• Status: Recruiting
• Phase: Phase 4
• Start date: September 25, 2020
• Est. completion date: October 2022

Study information

• Verified date: October 2020
• Source: Danish Headache Center
• Contact: Messoud Ashina, MD
• Phone: +4538633385
• Email: ashina[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Erenumab
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

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