Migraine
Conditions
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.
Interventions
Pure observatonnal study
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| Concomitant treatments | 6 months | Use of concomitant crisis and background treatments (description) |
Countries
France
Outcome results
None listed