Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of … (NCT05518123) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications
United States, Australia, Austria962 participantsStarted 2022-11-07
Plain-language summary
This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
. Migraine attacks, on average, lasting about 4 - 72 hours, if untreated.
. 4 to 14 migraine days per month, on average, across the 3 months prior to the Screening Visit (month is defined as 28-days for the purpose of this protocol).
. Less than15 headache days (migraine or non-migraine) per month in each of the 3-months prior to the Screening Visit and throughout the Screening Phase.
. Subjects must be able to distinguish migraine attacks from tension/cluster headaches. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication).
Exclusion criteria
. History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
. Current medication overuse headaches.
. 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the first 28- days of the Observation Phase.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Timeframe: Observation phase (28 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12])
. Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across \> 4 categories of recognized, orally administered, migraine-preventive medications.
. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \[CRPS\]).
. Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy.