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

Migraine Clinical Trial

— EVIREMIG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05947123
• Other study ID #: 2023-07Obs-CHRMT
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: Arpiné EL NAR, PhD
• Phone: 0033387557766
• Email: arpine.el-nar[@]chr-metz-thionville.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
France	CHR Metz-Thionville/Hopital de Mercy	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Migraine occurence in patients with migraine at 12 months	Number of migraine days	12 months after prophylactic treatments
Secondary	Crisis treatments in patients with migraine at 12 months	Number of crisis treatments taken	12 months after prophylactic treatments
Secondary	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
Secondary	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
Secondary	Most Bothersome Symptom in patients with migraine at 12 months	Most Bothersome Symptom (MBS)	12 months after prophylactic treatments
Secondary	Days off work at 12 months	Number of days off work	12 months after prophylactic treatments
Secondary	Emergency room visits at 12 months	Number of emergency room visits	12 months after prophylactic treatments
Secondary	Type of prophylactic treatment used at 12 months	Type of prophylactic treatment	12 months after prophylactic treatments