Skip to main content
OpenTrials
Completed

NCT Number: NCT06446804

Follow-up of Migraine Patients on Eptinezumab

The October 2022 Transparency Commission considers that VYEPTI (eptinezumab) is a treatment option for patients suffering from severe migraine with at least 8 migraine days per month, who have failed at least two prophylactic treatments and have no cardiovascular impairment.

Since the beginning of 2023, eptinezumab has been available in France as an inpatient treatment prescribed by a migraine neurologist in a growing number of centres. The Saint-Denis Hospital and the Nîmes University Hospital are among the first centres to have started. The investigators from these 2 centres have therefore decided to pool their data to provide the first French feedback on its effectiveness.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes, Nîmes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients suffering from severe migraine with at least 8 migraine days per month
  • Patients who have failed at least 2 disease-modifying treatments,
  • Patients treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at Saint-Denis Hospital and Nîmes University Hospital.

Exclusion criteria

  • Patient refusing to participate

Treatment and study plan

None, pure observationnal study

Other

Pure observatonnal study

Primary outcomes

  1. Headaches and migraines per month

    Time frame: 6 months

    Number of headache and migraine days per month.

  2. Responders

    Time frame: 6 months

    Rate of responders (30%, 50% and super responders > 75%)

  3. Duration

    Time frame: 6 months

    Duration of effect of eptinezumab infusion (Numbers of weeks)

  4. HIT6 scores (disability score)

    Time frame: 6 months

    Evaluation of HIT6 scores (disability score),

    ≤ 49 headaches have little impact on daily life; between 50 and 55: headaches have some impact on daily life; 56 to 59: headaches have a significant impact on daily life; ≥ 60

  5. HAD (anxiety/depression score)

    Time frame: 6 months

    Evaluation of HAD score. From 0 to 7: absence of anxiety and/or depressive disorders, from 8 to 10: doubtful symptomatology, 11 to 21: proven anxiety and/or depression disorders of varying severity.

  6. Concomitant treatments

    Time frame: 6 months

    Use of concomitant crisis and background treatments (description)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Feedback on the Use of Eptinezumab: Efficacy at 6 Months in Severe Migraine

Acronym: EPTI-CO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.