Follow-up of Migraine Patients on Eptinezumab (EPTI-CO)

October 31, 2024 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30900
        • CHU de Nîmes
      • Saint-Denis, France, 93200
        • CH de Saint Denis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive patients with severe migraine with at least 8 migraine days per month and failure of at least 2 disease-modifying therapies, treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at the Saint-Denis hospital and the Nîmes university hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Migraine patients
Patients with severe migraine, with at least 8 migraine days per month and at least 2 failed background treatments.
Other: None, pure observationnal study
Pure observatonnal study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headaches and migraines per month
Time Frame: 6 months
Number of headache and migraine days per month.
6 months
Responders
Time Frame: 6 months
Rate of responders (30%, 50% and super responders > 75%)
6 months
Duration
Time Frame: 6 months
Duration of effect of eptinezumab infusion (Numbers of weeks)
6 months
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
6 months
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 months
Concomitant treatments
Time Frame: 6 months
Use of concomitant crisis and background treatments (description)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2024/AL-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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