Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409845
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-05
Brief Title:
Effectiveness and Tolerability of Eptinezumab
Sponsor:
University of Florence
Organization:
University of Florence
Study Overview
Official Title:
Effectiveness and Tolerability of Eptinezumab a Prospective Multicentric Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACHIS
Brief Summary:
The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of eptinezumab as preventive migraine treatment in a cohort of episodic or chronic migraine patients
Detailed Description:
Eptinezumab belongs to the monoclonal antibodies directed against the calcitoning gene related peptide - CGRP mAbs It is actually the only mAb administered intravenously currently available at the dose of 100 or 300mg with a quarterly iv infusion
It has an indication for migraine prevention for episodic and chronic migraine Previous randomized placebo-controlled clinical trials proved its effectiveness in the preventive setting for patients with episodic and chronic migraine
Moreover a previous study also supported evidence of faster headache pain freedom and most bothersome symptom resolution after eptinezumab 100mg infusion during migraine acute attack compared to placebo
RCTs also demonstrated a good tolerability profile The most commonly reported adverse events were mainly upper respiratory tract infections fatigue and hypersensitivity reactions
In this prospective multicentric study the investigators aim to evaluate eptinezumab effectiveness and tolerability as preventive migraine treatment in a real-world setting
Subjects who meet the inclusion criteria will be enrolled and will participate in the study Baseline demographic and clinical data will be collected at the baseline visit The observation period will last for two years during which patients will be administered eptinezumab 100 or 300 mg according to clinicians judgment for a time period related to Italian Medicines Agency reimbursability criteria
Data will be collected at baseline and every three months up to two years Subjects will be asked to keep a headache diary to collect monthly headache and migraine days migraine severity associated symptoms and drug consumption Questionnaires will be collected every three months
Data collection will focus on i demographic data ii migraine history iii pain intensity iv presence and evolution of migraine associated symptoms and aura v migraine associated disability vi tolerability and eventual treatment- emergent adverse events vii treatment persistence viii questionnaires related to disability allodynia quality of life interictal burden and effectiveness of the ongoing acute and preventive treatments The online database REDCap will be used for data collection
It has an indication for migraine prevention for episodic and chronic migraine Previous randomized placebo-controlled clinical trials proved its effectiveness in the preventive setting for patients with episodic and chronic migraine
Moreover a previous study also supported evidence of faster headache pain freedom and most bothersome symptom resolution after eptinezumab 100mg infusion during migraine acute attack compared to placebo
RCTs also demonstrated a good tolerability profile The most commonly reported adverse events were mainly upper respiratory tract infections fatigue and hypersensitivity reactions
In this prospective multicentric study the investigators aim to evaluate eptinezumab effectiveness and tolerability as preventive migraine treatment in a real-world setting
Subjects who meet the inclusion criteria will be enrolled and will participate in the study Baseline demographic and clinical data will be collected at the baseline visit The observation period will last for two years during which patients will be administered eptinezumab 100 or 300 mg according to clinicians judgment for a time period related to Italian Medicines Agency reimbursability criteria
Data will be collected at baseline and every three months up to two years Subjects will be asked to keep a headache diary to collect monthly headache and migraine days migraine severity associated symptoms and drug consumption Questionnaires will be collected every three months
Data collection will focus on i demographic data ii migraine history iii pain intensity iv presence and evolution of migraine associated symptoms and aura v migraine associated disability vi tolerability and eventual treatment- emergent adverse events vii treatment persistence viii questionnaires related to disability allodynia quality of life interictal burden and effectiveness of the ongoing acute and preventive treatments The online database REDCap will be used for data collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None