Follow-up of Migraine Patients on Eptinezumab

Completed

• Conditions: Migraine
• Interventions: Other: None, pure observationnal study

• Registration Number: NCT06446804
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-30
• Study Start: 2024-06-01
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-06
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Migraine patients	None, pure observationnal study	Patients with severe migraine, with at least 8 migraine days per month and at least 2 failed background treatments.

Primary Outcome Measures

Name	Time	Method
Concomitant treatments	6 months	Use of concomitant crisis and background treatments (description)
HIT6 scores (disability score)	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
HAD (anxiety/depression score)	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.
Headaches and migraines per month	6 months	Number of headache and migraine days per month.
Responders	6 months	Rate of responders (30%, 50% and super responders \> 75%)
Duration	6 months	Duration of effect of eptinezumab infusion (Numbers of weeks)

Trial Locations

Locations (2)

CHU de Nîmes; 🇫🇷 Nîmes, France

CH de Saint Denis; 🇫🇷 Saint-Denis, France