Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467370
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-14
Brief Title:
A Real-world Prospective Observational Study of Rimegepant ODT for the Acute Treatment of Migraine Attacks in Adults
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
CONFIDENCE A Prospective Observational Study With Acute Treatment of Rimegepant ODT on Consistency Satisfaction and Tolerability of Treatment in the Real World
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
CONFIDENCE
Brief Summary:
This study aims at characterizing the effectiveness of rimegepant as an acute migraine treatment in a real world setting on two aspects
Consistency of response to rimegepant across multiple attacks
Effectiveness of rimegepant in users taking concomitant migraine preventive medications namely monoclonal antibodies targeting CGRP and onabotulinumtoxinA
Consistency of response to rimegepant across multiple attacks
Effectiveness of rimegepant in users taking concomitant migraine preventive medications namely monoclonal antibodies targeting CGRP and onabotulinumtoxinA
Detailed Description:
This study will be conducted in a real-world setting in the US using a bespoke interface contained in the Migraine Buddy mobile application Participants who report using rimegepant for the acute treatment of migraine will be recruited and will be asked to complete a series of questionnaires during the screening and study period Patient reported outcome measures will be collected at study enrollment daily during the 28-day observation period and at the end of the study period
Research Questions
1 In adult patients currently receiving a prescription for rimegepant for the acute treatment of migraine what is the population-level consistency of rimegepant response for pain reduction meaningful pain relief performance in daily activities and return to normal function across multiple attacks in a real-world setting regardless of prophylactic background
2 What is the satisfaction level of patients receiving rimegepant on background migraine prophylaxis specifically anti-CGRP mAbs or onabotulinumtoxinA Botox
3 What is the efficacy safety and tolerability of rimegepant for the acute treatment of migraine when taken in combination with preventive medications that act on the same pathway
Research Questions
1 In adult patients currently receiving a prescription for rimegepant for the acute treatment of migraine what is the population-level consistency of rimegepant response for pain reduction meaningful pain relief performance in daily activities and return to normal function across multiple attacks in a real-world setting regardless of prophylactic background
2 What is the satisfaction level of patients receiving rimegepant on background migraine prophylaxis specifically anti-CGRP mAbs or onabotulinumtoxinA Botox
3 What is the efficacy safety and tolerability of rimegepant for the acute treatment of migraine when taken in combination with preventive medications that act on the same pathway
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CONFIDENCE | OTHER | None | None |
| AUDACITY | OTHER | None | None |