Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136442
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-11-13
Brief Title:
Atogepant in Real Life in Italy GIANT
Sponsor:
IRCCS San Raffaele Roma
Organization:
IRCCS San Raffaele Roma
Study Overview
Official Title:
Atogepant in Real Life in Italy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
GIANT
Brief Summary:
Atogepant is an oral small-molecule calcitonin gene-related peptide CGRP receptor antagonist that has been approved for the preventive treatment of episodic and chronic migraine 4 monthly migraine days with or without medication overuse
Detailed Description:
This study is designed to confirm the effectiveness and safety of atogepant in real life The primary endpoint is the change from baseline in the mean number of monthly migraine days MMDsacross the 12 weeks Secondary endpoints include change in monthly analgesic intake Numeric Rating Scale NRS Headache Impact Test-6 HIT-6 and Migraine disability assessment MIDAS scores 50 75 100 responders 50 75 100 responders in patients with medication overuse at weeks 9-12 compared to baseline and adverse events eventually occur during 12 weeks of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None