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

Study Overview
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Brief Summary
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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.

Official Title
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Real-life Study of the Efficacy of Management of Migraine Patients After Failure of 2 Prophylactic Treatments: a Retrospective Study

Conditions
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Migraine

Intervention / Treatment
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* Behavioral: Patient health care observational follow up after 2 prophylactic tratments


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Impact Test in patients with migraine at 12 months | 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. | 12 months after prophylactic treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache-related disability in patients with migraine at 12 months | 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. | 12 months after prophylactic treatments | 
| Anxiety and Depression state evaluation in patients with migraine at 12 months | 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. | 12 months after prophylactic treatments | 
| Migraine occurence in patients with migraine at 12 months | Number of migraine days | 12 months after prophylactic treatments | 
| Crisis treatments in patients with migraine at 12 months | Number of crisis treatments taken | 12 months after prophylactic treatments | 
| Patient Global Impression of Change in patients with migraine at 12 months | 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. | 12 months after prophylactic treatments | 
| Work and Personal Activities Impairment in patients with migraine at 12 months | 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). | 12 months after prophylactic treatments | 
| Most Bothersome Symptom in patients with migraine at 12 months | Most Bothersome Symptom (MBS) | 12 months after prophylactic treatments | 
| Days off work at 12 months | Number of days off work | 12 months after prophylactic treatments | 
| Emergency room visits at 12 months | Number of emergency room visits | 12 months after prophylactic treatments | 
| Type of prophylactic treatment used at 12 months | Type of prophylactic treatment | 12 months after prophylactic treatments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, prophylactic treatment, real life