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MigrainePhase 4REFORMNCT04603976

Registry for Migraine - Clinical Core

A Phase 4 study testing Erenumab in people with Migraine, run by Danish Headache Center at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
What is being tested?
Erenumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteDenmark
Study dates
25 Sep 2020to Oct 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Messoud Ashina, MD contact

+4538633385

ashina@dadlnet.dk

Faisal Amin, MD contact

+4538633186

amin.faisal@hotmail.com

Denmark1 site, 1 recruiting

  • Danish Headache Center

    Glostrup Municipality, 2600

    Messoud Ashina, MD, +45 38 63 33 85, ashina@dadlnet.dk

    Faisal Amin, MD, +4538633186, amin.faisal@hotmail.com

    Recruiting

Other trials in Denmark

About this study

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.

Read the 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.

Conditions
Migraine
Being tested
Erenumab
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErenumabDrug

    Also called Aimovig

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

Study groups in NCT04603976
Study groupRoleWhat they receive
Single-ArmExperimentalErenumab packed in a SureClick® Autoinjector Pen (AI)
Receives: Drug: Erenumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache Diary

    Headache diary with daily entries to record migraine-related data.

    Measured: Baseline Phase (Day -28 to Day 1) to Week 24

Secondary outcomes (18)

  1. Headache Diary

    Headache diary with daily entries to record migraine-related data.

    Measured: Baseline Phase (Day -28 to Day 1) to Week 48

  2. Semi-Structured Interview

    In-person semi-structured interview to record migraine-related data.

    Measured: Screening Visit (Day -28)

  3. Headache Impact Test (HIT-6)

    6-item questionnaire to assess headache-related disability

    Measured: Baseline Phase (Day -28 to Day 1) to Week 24

  4. Headache Impact Test (HIT-6)

    6-item questionnaire to assess headache-related disability

    Measured: Baseline Phase (Day -28 to Day 1) to Week 48

  5. Migraine Disability Assessment Test (MIDAS)

    7-item questionnaire to assess migraine-related disability

    Measured: Baseline Phase (Day -28 to Day 1) to Week 24

  6. Migraine Disability Assessment Test (MIDAS)

    7-item questionnaire to assess migraine-related disability

    Measured: Baseline Phase (Day -28 to Day 1) to Week 48

  7. Hospital Anxiety and Depression Scale (HADS)

    14-item questionnaire to assess anxiety and depression

    Measured: Baseline Phase (Day -28 to Day 1) to Week 24

  8. Hospital Anxiety and Depression Scale (HADS)

    14-item questionnaire to assess anxiety and depression

    Measured: Baseline Phase (Day -28 to Day 1) to Week 48

  9. Pittsburgh Sleep Quality Index (PSQI)

    19-item questionnaire to assess quality of sleep

    Measured: Baseline Phase (Day -28 to Day 1) to Week 24

  10. Pittsburgh Sleep Quality Index (PSQI)

    19-item questionnaire to assess quality of sleep

    Measured: Baseline Phase (Day -28 to Day 1) to Week 48

  11. 12-item Allodynia Symptom Checklist (ASC-12)

    12-item questionnaire to allodynia

    Measured: Baseline Phase (Day -28 to Day 1) to Week 24

  12. 12-item Allodynia Symptom Checklist (ASC-12)

    12-item questionnaire to allodynia

    Measured: Baseline Phase (Day -28 to Day 1) to Week 48

  13. WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Questionnaire to assess health status and disability

    Measured: Baseline Phase (Day -28 to Day 1) to Week 24

  14. WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Questionnaire to assess health status and disability

    Measured: Baseline Phase (Day -28 to Day 1) to Week 48

  15. Neck Disability Index (NDI)

    Questionnaire to assess neck disability

    Measured: Baseline Phase (Day -28 to Day 1) to Week 24

  16. Neck Disability Index (NDI)

    Questionnaire to assess neck disability

    Measured: Baseline Phase (Day -28 to Day 1) to Week 48

  17. Low Back Pain Disability Questionnaire

    Questionnaire to assess low back pain disability

    Measured: Baseline Phase (Day -28 to Day 1) to Week 24

  18. Low Back Pain Disability Questionnaire

    Questionnaire to assess low back pain disability

    Measured: Baseline Phase (Day -28 to Day 1) to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2020
  2. Study start25 Sep 2020
  3. Primary completionOct 2022 (estimated)
  4. Study completionOct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04603976
Sponsor's protocol ID
20019411
Acronym
REFORM
Status last verified
Oct 2020
First submitted
7 Oct 2020
Last updated
27 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Thuraiaiyah J, Christensen RH, Al-Khazali HM, Ashina M, Katsarava Z, Ashina H. MIDAS and HIT-6 Questionnaires Versus Headache Diaries for Monitoring Treatment Response to Erenumab in Migraine: A REFORM Study. Eur J Neurol. 2026 Apr;33(4):e70542. doi: 10.1111/ene.70542.

    PubMed 41902353

  • Jakobsen JT, Karlsson WK, Christensen RH, Al-Khazali HM, Ashina M, Ashina H. Effects of erenumab on migraine aura frequency: a REFORM study. J Headache Pain. 2026 Mar 26;27(1):129. doi: 10.1186/s10194-026-02338-7.

    PubMed 41888647

  • Thuraiaiyah J, Christensen RH, Al-Khazali HM, Wiggers A, Ashina M, Ashina H. Overlap between perceived triggers, premonitory symptoms and symptom persistence across migraine phases: A REFORM study. Cephalalgia. 2025 Aug;45(8):3331024251364234. doi: 10.1177/03331024251364234. Epub 2025 Aug 26.

    PubMed 40980937

  • Karlsson WK, Christensen RH, Al-Khazali HM, Kallemose T, Jawad BN, Andersen O, Ashina M, Ashina H. Plasma SuPAR and therapeutic response to erenumab in migraine: a REFORM study. J Headache Pain. 2025 Apr 24;26(1):86. doi: 10.1186/s10194-025-02037-9.

    PubMed 40275185

  • Karlsson WK, Ashina H, Cullum CK, Christensen RH, Al-Khazali HM, Amin FM, Ashina M; REFORM Investigators. The Registry for Migraine (REFORM) study: methodology, demographics, and baseline clinical characteristics. J Headache Pain. 2023 Jun 12;24(1):70. doi: 10.1186/s10194-023-01604-2.

    PubMed 37303034

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Erenumab in people with Migraine, run by Danish Headache Center at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Messoud Ashina, MD (+4538633385, ashina@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache Diary (time frame: Baseline Phase (Day -28 to Day 1) to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04603976, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.

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