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

NCT05947123 | Completed

• 1 other identifier: 2023-07Obs-CHRMT
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

migraine; prophylactic treatment; real life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Headache-related disability in patients with migraine at 12 months

  12 months after prophylactic treatments

• Anxiety and Depression state evaluation in patients with migraine at 12 months

  12 months after prophylactic treatments

• Migraine occurence in patients with migraine at 12 months

  12 months after prophylactic treatments

• Crisis treatments in patients with migraine at 12 months

  12 months after prophylactic treatments

• Patient Global Impression of Change in patients with migraine at 12 months

  12 months after prophylactic treatments

Interventions

Patient health care observational follow up after 2 prophylactic tratments BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Migraine \[International Headache Society (IHS) criteria 2013, revised 2018\] with or without aura

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Xavier DUCROCQ, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 17, 2023
• Study Start: June 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)