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

NCT ID: NCT05947123

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-03-01

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.

Detailed Description

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Conditions

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Migraine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier DUCROCQ, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz Thionville Hopital de Mercy

Locations

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CHR Metz-Thionville/Hopital de Mercy

Metz, , France

Site Status

Countries

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France

Other Identifiers

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2023-07Obs-CHRMT

Identifier Type: -

Identifier Source: org_study_id

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