Gepant treAtments: EffectIveNess and tolERability (GAINER)

Migraine Clinical Trial

— GAINER  

Official title:

Effectiveness and Tolerability of Rimegepant as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study (GAINER)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05903027
• Other study ID #: RICe_1
• Status: Recruiting
• Start date: June 15, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: University of Florence
• Contact: Luigi F Iannone, MD
• Phone: +393896969606
• Email: luigifrancesco.iannone[@]unifi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine
• Migraine Disorders
• Migraine with Aura
• Migraine Without Aura

Intervention

Drug:
• Rimegepant 75 MG Disintegrating Oral Tablet
Patients using Rimegepant 75 mg orally disintegrating tablet to treat acute migraine attacks

Locations

Country	Name	City	State
Italy	SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi	Florence
Italy	IRCCS National Neurological Institute "C. Mondino" Foundation	Pavia

Sponsors (18)

Lead Sponsor

Collaborator

University of Florence

ASST Spedali Civili, Brescia, Auxologico San Luca, Milano, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Azienda Ospedaliera S. Maria della Misericordia, Azienda Ospedaliero Universitaria Policlinico Modena, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Azienda Ospedaliero-Universitaria di Parma, Azienda Policlinico Umberto I, Carlo Besta Neurological Institute, Cliniche Humanitas Gavazzeni, IRCCS National Neurological Institute "C. Mondino" Foundation, Ospedale di Piove di Sacco, Ospedale di Prato, Società italiana per lo studio delle Cefalee (SISC), Università degli Studi dell'Aquila, University of Campania "Luigi Vanvitelli", University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745. doi: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13. — View Citation

Lipton RB, Blumenfeld A, Jensen CM, Croop R, Thiry A, L'Italien G, Morris BA, Coric V, Goadsby PJ. Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: Pooled results from three phase 3 randomized clinical trials. Cephalalgia. 2023 Feb;43(2):3331024221141686. doi: 10.1177/03331024221141686. — View Citation

Lipton RB, Croop R, Stock EG, Stock DA, Morris BA, Frost M, Dubowchik GM, Conway CM, Coric V, Goadsby PJ. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019 Jul 11;381(2):142-149. doi: 10.1056/NEJMoa1811090. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache pain freedom at 2 hours post-dose during the first attack	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).	2 hours post-dose
Primary	Occurrence of treatment-emergent adverse events	To evaluate the safety and tolerability of Rimegepant in migraine subjects.	12 weeks
Secondary	Headache pain freedom at 2 hours post-dose across 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).	2 hours post-dose for all treated attacks
Secondary	Headache pain relief at 2 hours post-dose during the first attack	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).	2 hours post-dose
Secondary	Headache pain relief at 2 hours post-dose across 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).	2 hours post-dose for all treated attacks
Secondary	Ability to function normally at 2 hours post-dose during the first attack	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.	2 hours post-dose
Secondary	Ability to function normally at 2 hours post-dose across 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.	2 hours post-dose for all treated attacks
Secondary	Freedom from the most bothersome symptom (MBS) associated with migraine at 2 hours post-dose during the first attack	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).	2 hours post-dose
Secondary	Headache recurrence for the first-attack	Percentage of subjects who became pain free at 2 hours post-dose and report new headache pain within 24 hours post-dose.	between 2 hours and 24 hours post-dose
Secondary	Rescue medications use for the first attack	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)	between 2 hours and 24 hours post dose
Secondary	Treatment satisfaction	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).	2 hours post-dose for all treated attacks
Secondary	Self-reported treatment effectiveness	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.	12 weeks