Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409832
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-05
Brief Title:
RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment
Sponsor:
University of Florence
Organization:
University of Florence
Study Overview
Official Title:
RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment a Prospective Multicentric Cohort Study RAISE
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAISE
Brief 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
Detailed Description:
Rimegepant belongs to the gepants family small molecules calcitonin gene- related peptide CGRP receptor antagonists It is a new generation gepant 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 migraine A previous randomized placebo-controlled phase 23 trial demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine Previous studies also demonstrated a good tolerability profile The most commonly reported adverse events were nausea nasopharyngitis upper respiratory tract infections and urinary tract infections
In this prospective multicentric study the investigators aim to evaluate rimegepant effectiveness and tolerability as preventive 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 visit The observation period will last for two years during which patients will take rimegepant 75 mg orally disintegrating tablet every other day for a time period related to eventual approval of reimbursability criteria
Data will be collected at baseline and every three months for two years Subjects will be asked to keep a headache diary to collect monthly headache and migraine days migraine severity associated symptoms and drug consumption Questionnaires will be collected every three months
Data collection will focus on i demographic data ii migraine history iii pain intensity iv presence and evolution of migraine associated symptoms and aura v migraine associated disability vi tolerability and eventual treatment- emergent adverse events vii treatment persistence viii questionnaires related to disability allodynia quality of life interictal burden and effectiveness of the ongoing acute and preventive treatments The online database REDCap will be used for data collection
It has a double indication both for acute treatment for migraine with and without aura and preventive treatment of migraine A previous randomized placebo-controlled phase 23 trial demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine Previous studies also demonstrated a good tolerability profile The most commonly reported adverse events were nausea nasopharyngitis upper respiratory tract infections and urinary tract infections
In this prospective multicentric study the investigators aim to evaluate rimegepant effectiveness and tolerability as preventive 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 visit The observation period will last for two years during which patients will take rimegepant 75 mg orally disintegrating tablet every other day for a time period related to eventual approval of reimbursability criteria
Data will be collected at baseline and every three months for two years Subjects will be asked to keep a headache diary to collect monthly headache and migraine days migraine severity associated symptoms and drug consumption Questionnaires will be collected every three months
Data collection will focus on i demographic data ii migraine history iii pain intensity iv presence and evolution of migraine associated symptoms and aura v migraine associated disability vi tolerability and eventual treatment- emergent adverse events vii treatment persistence viii questionnaires related to disability allodynia quality of life interictal burden and effectiveness of the ongoing acute and preventive treatments The online database REDCap will be used for data collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None