Gepant TreAtments: EffectIveNess and TolERability (GAINER)

Recruiting

• Conditions: Migraine; Migraine with Aura; Migraine Without Aura; Chronic Migraine
• Interventions: Drug: Rimegepant 75 MG Disintegrating Oral Tablet

• Registration Number: NCT05903027
• Lead Sponsor: University of Florence

Brief Summary

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

Detailed Description

Rimegepant belongs to the gepants family, small molecules calcitonin gene-related peptide (CGRP) receptor antagonists. It is a new generation gepants, currently available as an orally disintegrating tablet at a single dose of 75 mg. It has a double indication both for acute treatment for migraine with and without aura and preventive treatment of episodic migraine. Previous randomized, placebo-controlled phase 3 trials and open label extensions demonstrated its effectiveness in the acute setting for a single migraine attack of both the oral tablet and the orally disintegrating tablet. Pooled analysis of previous randomized clinical trials also showed rimegepant effectiveness in patients with a history of insufficient response to triptans.

Previous studies also demonstrated a good tolerability profile. The most commonly reported adverse events were nausea, nasopharyngitis, upper respiratory tract infections and urinary tract infection.

In this prospective multicentric study we aim to evaluate Rimegepant effectiveness and tolerability as acute 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 be asked to treat their next migraine attack with Rimegepant 75 mg orally disintegrating tablet.

Data will be collected at baseline, during at least 4 migraine attacks treated with Rimegepant and at 3 months follow-up.

Subjects will be asked to complete assessment of their migraine attack at baseline and at 30 - 60 - 90 and 120 minutes after administration of the acute treatment for at least four migraine attacks. A final timepoint at 24 hours post-dose will be assessed only for the first attack.

Data collection will focus on: i) demographic data, ii) migraine history, iii) pain level and evolution, iv) presence and evolution of migraine associated symptoms, most bothersome symptom and aura, v) migraine associated disability, vi) patients's global impression of change (PGIC) and evaluation on the acute treatment (Migraine-ACT), vii) tolerability and eventual treatment-emergent adverse events. The online database REDCap will be used for data collection.

Study Timeline

• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Study Start: 2023-06-15
• Study First Posted: 2023-06-15
• Status Verified: 2023-12
• Primary Completion: 2024-06-15
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-08
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III).
• At least 3 MMDs
• Good compliance to study procedures
• Availability of headache diary at least of the preceding months before enrollment

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Exclusion Criteria

• Subjects with contraindications for use of gepants;
• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Episodic migraine	Rimegepant 75 MG Disintegrating Oral Tablet	Patients affected by an episodic pattern migraine(\< 15 monthly headache days) with or without aura according to ICHD-III criteria.
Chronic migraine	Rimegepant 75 MG Disintegrating Oral Tablet	Patients affected by chronic migraine according to ICHD-III criteria.

Primary Outcome Measures

Name	Time	Method
Headache pain freedom at 2 hours post-dose during the first attack	2 hours post-dose	The percentage of subjects that report no headache pain at 2 hours after drug intake. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Occurrence of treatment-emergent adverse events	12 weeks	To evaluate the safety and tolerability of Rimegepant in migraine subjects.

Secondary Outcome Measures

Name	Time	Method
Headache pain freedom at 2 hours post-dose across all treated attacks	2 hours post-dose for all treated attacks	The percentage of subjects that report no headache pain at 2 hours after drug intake across all' treated attacks. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Headache pain relief at 2 hours post-dose during the first attack	2 hours post-dose	The percentage of subjects that report mild or none headache pain at 2 hours after drug intake during the first attack. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Headache pain relief at 2 hours post-dose across all treated attacks	2 hours post-dose for all treated attacks	The percentage of subjects that report mild or none headache pain at 2 hours after drug intake across all treated attack. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Ability to function normally at 2 hours post-dose during the first attack	2 hours post-dose	The percentage of subjects that self-report no functional disability at 2 hours post-dose. Functional disability will be assessed through the Functional Disability Scale (FDS), a four-point scale: normal, mildly impaired, severely impaired, requires daily activities interruption.
Ability to function normally at 2 hours post-dose across all treated attacks	2 hours post-dose for all treated attacks	The percentage of subjects that self-report no functional disability at 2 hours post-dose. Functional disability will be assessed through the Functional Disability Scale, a four-point scale: normal, mildly impaired, severely impaired, requires daily activities interruption.
Freedom from the most bothersome symptom (MBS) associated with migraine at 2 hours post-dose during the first attack	2 hours post-dose	The percentage of subjects that report complete MBS resolution at 2 hours after drug intake. MBS will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Headache recurrence for the first-attack	between 2 hours and 24 hours post-dose	Percentage of subjects who became pain free at 2 hours post-dose and report new headache pain within 24 hours post-dose.
Rescue medications use for the first attack	between 2 hours and 24 hours post dose	Percentage of subjects who take a rescue medication after 2 hour post-dose. Rescue medications will be measured using a binary scale (0=no consumption, 1=consumption)
Treatment satisfaction	2 hours post-dose for all treated attacks	Level of patients' self-reported satisfaction which will be measured on a 0-10 visual analogue scale (0=no satisfaction, 10= the highest satisfaction) and Patients Global Impression of Change (0= no changing, 7= a change that makes the difference).
Self-reported treatment effectiveness	12 weeks	Level of patients' self-reported treatment effectiveness measured by Migraine Assessment of Current Therapy (Migraine-ACT) a 4-item questionnaire about treatment effectiveness and daily life repercussions.

Trial Locations

Locations (2)

IRCCS National Neurological Institute "C. Mondino" Foundation; 🇮🇹 Pavia, Italy

SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi; 🇮🇹 Florence, Italy