A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults (NCT05989048) | Clinical Trial Compass
CompletedPhase 3
A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults
China, South Korea, Taiwan1,414 participantsStarted 2023-11-29
Plain-language summary
The purpose of this study is to learn how safe and effective zavegepant is compared to placebo in the acute treatment of migraine in Asian adults. Migraine is a very painful headache with other associated symptoms such as nausea, photophobia and phonophobia. A placebo is a harmless treatment that has no medical effect.
This study is seeking for participants who:
* have at least 1 year of migraine history before entering the study.
* have 2 to 8 migraine headache attacks of moderate or severe intensity in each of the 3 months before entering the study.
* have less than 15 days with headaches in each of the 3 months before entering the study. The headaches could be either due to migraine or not.
The participants in this study will receive zavegepant or placebo through intranasal route. Intranasal means medicine which is given through nose. Zavegepant or placebo will be taken if the participants have a migraine headache of moderate or severe intensity.
The study will compare the experiences of people receiving zavegepant to those of the people receiving placebo. This will help see if zavegepant is safe and effective in Asian adults.
Participants will be in this study for up to about 16 weeks. Participants will have 3 study visits at the study clinic and 1 through telephone contact.
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.
. Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months.
. Participants must be able to distinguish migraine attacks from tension/cluster headaches.
. At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
. Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
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
Percentage of Participants With Pain Freedom at 2 Hours Post-dose
Timeframe: At 2 hours post-dose
2
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
. Participants on prophylactic migraine medication are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to Screening Visit, and if the dose is not expected to change through the End of Treatment Visit.
. Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.