Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414044
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-10
Brief Title:
Italian Real-life obServational Study on the effecTiveness sAfety and Tolerability of Atogepant in Migraine Patients
Sponsor:
University of Florence
Organization:
University of Florence
Study Overview
Official Title:
STudio Osservazionale SullEfficacia Sicurezza e tollerabilità di Atogepant in Pazienti Real Life Affetti da Emicrania in Italia Studio STAR
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:
STAR
Brief Summary:
The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of atogepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients
Detailed Description:
Atogepant is a small molecule calcitonin gene- related peptide CGRP receptor antagonist part of the gepants family It is a second generation gepant currently approved for the preventive treatment of episodic and chronic migraine
Previously randomized placebo-controlled phase 23 trials demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine associated with a good tolerability profile
The most commonly reported adverse events were upper respiratory tract infections urinary infections nausea and constipation
In this prospective multicentric study the investigators aim to evaluate atogepant 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
patients will take atogepant 60 mg daily for at least 12 weeks up to two years according to effectiveness tolerability and eventual approval of reimbursability criteria
Data will be collected at baseline and every three months for 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 The online database REDCap will be used for data collection
Previously randomized placebo-controlled phase 23 trials demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine associated with a good tolerability profile
The most commonly reported adverse events were upper respiratory tract infections urinary infections nausea and constipation
In this prospective multicentric study the investigators aim to evaluate atogepant 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
patients will take atogepant 60 mg daily for at least 12 weeks up to two years according to effectiveness tolerability and eventual approval of reimbursability criteria
Data will be collected at baseline and every three months for 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 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