Follow-up of Migraine Patients on Eptinezumab

NCT06446804 | Completed

• 1 other identifier: LOCAL/2024/AL-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (6)

• Headaches and migraines per month

  Number of headache and migraine days per month.

  6 months

• Responders

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

  6 months

• Duration

  Duration of effect of eptinezumab infusion (Numbers of weeks)

  6 months

• HIT6 scores (disability score)

  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)

  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

  Use of concomitant crisis and background treatments (description)

  6 months

Study Arms (1)

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

Interventions

None, pure observationnal study OTHER

Pure observatonnal study

Migraine patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient refusing to participate

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Nîmes

Nîmes, 30900, France

Location

CH de Saint Denis

Saint-Denis, 93200, 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

• Anissa MEGZARI

  Centre Hospitalier Universitaire de Nīmes

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 6, 2024
• Study Start: June 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

FR (2)