Clinical trial NCT05947123: Real-life Study of the Efficacy of Management of Migraine Patients After Failure of 2 Prophylactic Treatments
Official title: Real-life Study of the Efficacy of Management of Migraine Patients After Failure of 2 Prophylactic Treatments: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: migraine
prophylactic treatment
real life
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Migraine \[International Headache Society (IHS) criteria 2013, revised 2018\] with or without aura

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.


Eligibility 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.

Primary outcomes:
measure: Headache Impact Test in patients with migraine at 12 months
timeFrame: 12 months after prophylactic treatments
Secondary outcomes:
measure: Headache-related disability in patients with migraine at 12 months
timeFrame: 12 months after prophylactic treatments
measure: Anxiety and Depression state evaluation in patients with migraine at 12 months
timeFrame: 12 months after prophylactic treatments
measure: Migraine occurence in patients with migraine at 12 months
timeFrame: 12 months after prophylactic treatments
measure: Crisis treatments in patients with migraine at 12 months
timeFrame: 12 months after prophylactic treatments
measure: Patient Global Impression of Change in patients with migraine at 12 months
timeFrame: 12 months after prophylactic treatments
measure: Work and Personal Activities Impairment in patients with migraine at 12 months
timeFrame: 12 months after prophylactic treatments
measure: Most Bothersome Symptom in patients with migraine at 12 months
timeFrame: 12 months after prophylactic treatments
measure: Days off work at 12 months
timeFrame: 12 months after prophylactic treatments
measure: Emergency room visits at 12 months
timeFrame: 12 months after prophylactic treatments
measure: Type of prophylactic treatment used at 12 months
timeFrame: 12 months after prophylactic treatments
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital de Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Xavier DUCROCQ, MD
role: PRINCIPAL_INVESTIGATOR
References: