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Real-life Study of the Efficacy of Management of Migraine Patients After Failure of 2 Prophylactic Treatments (EVIREMIG)

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ClinicalTrials.gov Identifier: NCT05947123
Recruitment Status : Recruiting
First Posted : July 17, 2023
Last Update Posted : July 17, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

Study Description
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Brief Summary:

This is a real-life, observational, single-center cohort study to describe the efficacy of prophylactic treatment in patients after failure of at least 2 prophylactic treatments. Patients included in the study will be followed up in consultations or day hospitals according to their usual care, and will be asked to complete the MIgraine Disability Assessment (MIDAS), Headache Impact Test short-form (HIT-6), Patient Global Impression of Change (PGIC), Hospital Anxiety and Depression (HAD) scale and Work and Personal Activities Impairment (WPAI) questionnaires at each visit.

Data describing their care will be extracted from computerized patient records.


Condition or disease Intervention/treatment
Migraine Behavioral: Patient health care observational follow up after 2 prophylactic tratments

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-life Study of the Efficacy of Management of Migraine Patients After Failure of 2 Prophylactic Treatments: a Retrospective Study
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Intervention Details:
  • Behavioral: Patient health care observational follow up after 2 prophylactic tratments
    Real-life, observational, single-center cohort study to describe the efficacy of prophylactic treatment in patients after failure of at least 2 prophylactic treatments. Patients included in the study will be followed up in consultations or day hospitals according to their usual care, and will be asked to complete the MIDAS, HIT-6, PGIC, HAD and WPAI questionnaires at each visit. Data describing their care will be extracted from computerized patient records.

Outcome Measures
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Primary Outcome Measures :
  1. Headache Impact Test in patients with migraine at 12 months [ Time Frame: 12 months after prophylactic treatments ]

    Using HIT-6 (Headache Impact Test short-form) questionnaire which addresses six main domains affected by headaches, including pain, social functioning, role functioning, cognitive functioning, vitality and psychological stress. This survey is extremely useful for screening and monitoring how headaches affect patients in their day-to-day lives over time.

    Each item is answered on a 5-point Likert scale (6 = never, 8 = rarely, 10 = sometimes, 11 = very often, 13 = always). The scoring of the HIT-6 was derived to approximate the total score obtained from a larger battery of items, using results from item response theory (IRT) [10]. The final score is obtained from simple summation of the six items.



Secondary Outcome Measures :
  1. Headache-related disability in patients with migraine at 12 months [ Time Frame: 12 months after prophylactic treatments ]

    MIDAS scale (Migraine Disability Assessment) measures headache-related disability and improve doctor-patient communication about the functional consequences of migraine. The questionnaire was based on five disability questions that focus on lost time in three domains: schoolwork or work for pay; household work or chores; and family, social, and leisure activities.

    This instrument is scored as follows: 5 to 10 indicates little or no disability, 10 to 20 indicates moderate disability, and higher than 20 denotes severe disability.


  2. Anxiety and Depression state evaluation in patients with migraine at 12 months [ Time Frame: 12 months after prophylactic treatments ]

    Using Hospital Anxiety and Depression Scale (HADS) : is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score.

    The depression items tend to focus on the anhedonic symptoms of depression. Items are rated on a 4-point severity scale.

    The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.


  3. Migraine occurence in patients with migraine at 12 months [ Time Frame: 12 months after prophylactic treatments ]
    Number of migraine days

  4. Crisis treatments in patients with migraine at 12 months [ Time Frame: 12 months after prophylactic treatments ]
    Number of crisis treatments taken

  5. Patient Global Impression of Change in patients with migraine at 12 months [ Time Frame: 12 months after prophylactic treatments ]

    Using Patient Global Impression of Change (PGIC) score: a 7 point scale depicting a patient's rating of overall improvement.

    Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."


  6. Work and Personal Activities Impairment in patients with migraine at 12 months [ Time Frame: 12 months after prophylactic treatments ]

    Using Work and Personal Activities Impairment (WPAI) score : a well validated instrument to measure impairments in work and activities.

    WPAI scores are based on 1-item (presenteeism, activitity impairment), 2-items (absenteeism) and multiple items (overall work productivity).


  7. Most Bothersome Symptom in patients with migraine at 12 months [ Time Frame: 12 months after prophylactic treatments ]
    Most Bothersome Symptom (MBS)

  8. Days off work at 12 months [ Time Frame: 12 months after prophylactic treatments ]
    Number of days off work

  9. Emergency room visits at 12 months [ Time Frame: 12 months after prophylactic treatments ]
    Number of emergency room visits

  10. Type of prophylactic treatment used at 12 months [ Time Frame: 12 months after prophylactic treatments ]
    Type of prophylactic treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Migraine [International Headache Society (IHS) criteria 2013, revised 2018] with or without aura
Criteria

Inclusion Criteria:

  • Patients with Migraine [International Headache Society (IHS) criteria 2013, revised 2018] with or without aura
  • Monthly number of attacks ≥ 8 for at least 3 months
  • Indication for prophylactic treatment
  • For eptinezumab: resistance to at least 2 conventional disease-modifying therapies
  • Agrees to use data for research purposes

Exclusion Criteria:

  • Vascular history: myocardial infarction (MI), unstable angina or coronary bypass surgery, stroke or transient ischemic attack (TIA), Peripheral Arterial Disease of the Lower Limbs (PAD), uncontrolled hypertension

    • Need for analgesics for a cause other than migraine
    • Difficulty in understanding French language or cognitive impairment that compromises completion of self-questionnaires.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05947123


Contacts
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Contact: Arpiné EL NAR, PhD 0033387557766 arpine.el-nar@chr-metz-thionville.fr

Locations
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France
CHR Metz-Thionville/Hopital de Mercy Recruiting
Metz, France, 57085
Contact: Arpiné EL NAR, PhD    0033387557766    arpine.el-nar@chr-metz-thionville.fr   
Principal Investigator: Xavier DUCROCQ, MD         
Sub-Investigator: Pierre Alexandre BAILLOT, MD         
Sub-Investigator: Hélène DUCROCQ, MD         
Sub-Investigator: Basile WITTWER, MD         
Sub-Investigator: Jason BECKER, MD         
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
Investigators
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Principal Investigator: Xavier DUCROCQ, MD CHR Metz Thionville Hopital de Mercy
More Information
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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT05947123    
Other Study ID Numbers: 2023-07Obs-CHRMT
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: July 17, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional Metz-Thionville:
migraine
prophylactic treatment
real life
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases