Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Registry for Migraine - Clinical Core (REFORM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04603976
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Messoud Ashina, Danish Headache Center

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
Migraine Drug: Erenumab 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Registry for Migraine - Clinical Core
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

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 Name: Aimovig




Primary Outcome Measures :
  1. Headache Diary [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 24 ]
    Headache diary with daily entries to record migraine-related data.


Secondary Outcome Measures :
  1. Headache Diary [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 48 ]
    Headache diary with daily entries to record migraine-related data.

  2. Semi-Structured Interview [ Time Frame: Screening Visit (Day -28) ]
    In-person semi-structured interview to record migraine-related data.

  3. Headache Impact Test (HIT-6) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 24 ]
    6-item questionnaire to assess headache-related disability

  4. Headache Impact Test (HIT-6) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 48 ]
    6-item questionnaire to assess headache-related disability

  5. Migraine Disability Assessment Test (MIDAS) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 24 ]
    7-item questionnaire to assess migraine-related disability

  6. Migraine Disability Assessment Test (MIDAS) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 48 ]
    7-item questionnaire to assess migraine-related disability

  7. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 24 ]
    14-item questionnaire to assess anxiety and depression

  8. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 48 ]
    14-item questionnaire to assess anxiety and depression

  9. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 24 ]
    19-item questionnaire to assess quality of sleep

  10. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 48 ]
    19-item questionnaire to assess quality of sleep

  11. 12-item Allodynia Symptom Checklist (ASC-12) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 24 ]
    12-item questionnaire to allodynia

  12. 12-item Allodynia Symptom Checklist (ASC-12) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 48 ]
    12-item questionnaire to allodynia

  13. WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 24 ]
    Questionnaire to assess health status and disability

  14. WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 48 ]
    Questionnaire to assess health status and disability

  15. Neck Disability Index (NDI) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 24 ]
    Questionnaire to assess neck disability

  16. Neck Disability Index (NDI) [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 48 ]
    Questionnaire to assess neck disability

  17. Low Back Pain Disability Questionnaire [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 24 ]
    Questionnaire to assess low back pain disability

  18. Low Back Pain Disability Questionnaire [ Time Frame: Baseline Phase (Day -28 to Day 1) to Week 48 ]
    Questionnaire to assess low back pain disability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603976


Contacts
Layout table for location contacts
Contact: Messoud Ashina, MD +4538633385 ashina@dadlnet.dk
Contact: Faisal Amin, MD +4538633186 amin.faisal@hotmail.com

Locations
Layout table for location information
Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, 2600
Contact: Messoud Ashina, MD    +45 38 63 33 85    ashina@dadlnet.dk   
Contact: Faisal Amin, MD    +4538633186    amin.faisal@hotmail.com   
Principal Investigator: Messoud Ashina, MD         
Sponsors and Collaborators
Danish Headache Center
Investigators
Layout table for investigator information
Principal Investigator: Messoud Ashina, MD Danish Headache Center
Layout table for additonal information
Responsible Party: Messoud Ashina, Professor of Neurology, Danish Headache Center
ClinicalTrials.gov Identifier: NCT04603976    
Other Study ID Numbers: 20019411
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erenumab
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs