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Clinical Trials in Italy / NCT06409832
Recruiting Observational

RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment

NCT06409832 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Florence
Phase
Observational
Started
2024-03-26
Last updated
2026-06-11

Condition(s) studied

MigraineMigraine With AuraMigraine Without Aura

Investigational drug(s) / intervention(s)

Rimegepant 75 mg →

Rimegepant 75 mg: Patients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention

Study summary

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of migraine without aura or migraine with aura, according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III); * At least 4 monthly migraine days; * Good compliance to study procedures; * Availability of headache diary at least of the preceding months before enrollment. Exclusion Criteria: * Subjects with contraindications for use of gepants; * Diagnosis of chronic migraine * Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments; * medical comorbidities that could interfere with study results; * Pregnancy and breastfeeding. * Changes in preventive treatments in the month before the first administration of rimegepant

Primary outcome measure(s)

  • Changes in migraine frequency after three months of treatment — Baseline (T0) - 3 months of treatment with rimegepant (T3)
    Changes in monthly migraine days after three months of treatment with rimegepant compared to baseline (continuous variable)
  • Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment with rimegepant — Baseline (T0) - 3 months of treatment with rimegepant (T3)
    Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after three months of treatment with rimegepant

Trial sites (2)

FacilityCityRegionStatus
SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi Florence Florence Recruiting
IRCCS National Neurological Institute "C. Mondino" Foundation Pavia Pavia Recruiting

More University of Florence trials in Italy

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MELCAYA - Novel Health Care Strategies for Melanoma in Children, Adolescents, and Young Adults - Work Package 3 (WP3) Recruiting
Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy Recruiting

Other trials for the same condition

Neuropsychological Profile Characterization in Patients With Migraine: Cognitive Functioning and Psychological Variables Recruiting
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects Recruiting
Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine Active, not recruiting
The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study) Recruiting
Studio TIARA: Alessitimia ed Emicrania Cronica Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06409832 on ClinicalTrials.gov ↗ ← All trials in Italy