Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616194
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
AN INTERVENTIONAL EFFICACY AND SAFETY PHASE 3 RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks
Rimegepant is a tablet that dissolves when you put it on or under your tongue
The study will enroll participants who have headache for 15 days or more every month of which 8 days or more of migraine every month and each untreated attack lasts for an average of 4-72 hours
In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day and approximately half of the participants will receive an inactive oral tablet that looks the same as the rimegepant tablet every other day
Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet This will help to determine if the study medicine is safe and effective The 1st phase of the study will last 3 months
In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day This 2nd phase of the study will last 1 year This will help determine if the study medicine is safe when taken for a long period
Those who will participate in both phases will have up to 19 visits at the study clinic about one every 4 weeks this may vary from 2 to 8 weeks interval during the study Home health visits may occur as well A health check and blood sample will be conducted at all visits Participants will have to complete a daily diary to record the migraine attacks
Rimegepant is a tablet that dissolves when you put it on or under your tongue
The study will enroll participants who have headache for 15 days or more every month of which 8 days or more of migraine every month and each untreated attack lasts for an average of 4-72 hours
In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day and approximately half of the participants will receive an inactive oral tablet that looks the same as the rimegepant tablet every other day
Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet This will help to determine if the study medicine is safe and effective The 1st phase of the study will last 3 months
In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day This 2nd phase of the study will last 1 year This will help determine if the study medicine is safe when taken for a long period
Those who will participate in both phases will have up to 19 visits at the study clinic about one every 4 weeks this may vary from 2 to 8 weeks interval during the study Home health visits may occur as well A health check and blood sample will be conducted at all visits Participants will have to complete a daily diary to record the migraine attacks
Detailed Description:
None
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