NCT06136442

Atogepant in Real Life in Italy (GIANT)

Atogepant in Real Life in Italy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: IRCCS San Raffaele Roma · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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 (MMDs)across 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.

Conditions

• Migraine, Prophylaxis

Interventions

Type	Name	Description
DRUG	Atogepant	atogepant in real life in Italy

Timeline

• Start date: 2024-04-09
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2023-11-18
• Last updated: 2024-04-10

Regulatory

• FDA-regulated drug study