Follow-up of Migraine Patients on Eptinezumab

Migraine Clinical Trial

— EPTI-CO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446804
• Other study ID #: LOCAL/2024/AL-01
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Anne LE FLOCH
• Phone: 04 66 68 32 61
• Email: anne.lefloch[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• None, pure observationnal study
Pure observatonnal study

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes
France	CH de Saint Denis	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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