Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients

Sponsor
University of Florence
Study ID
NCT06414044
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atogepant 60 mg — DRUG
    Patients using atogepant 60 mg tablet daily as migraine prevention

Study Details

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.

Key Dates

Start date
May 9, 2024
Status verified
Jan 2026
Primary completion
Nov 30, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
500 participants (actual)

Arms

  • Arm: Episodic migraine
    Patients affected by migraine with an episodic pattern (\< 15 monthly migraine days) with or without aura according to ICHD-III criteria.
  • Arm: Chronic migraine
    Patients affected by chronic migraine (\> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria.

Primary Outcome Measure

Changes in migraine frequency after three months of treatment [ Time Frame: Baseline (T0) - 3 months of treatment with atogepant (T3) ]

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