Open Label Safety Study in Acute Treatment of Migraine (NCT03266588) | Clinical Trial Compass
CompletedPhase 2/3
Open Label Safety Study in Acute Treatment of Migraine
United States3,019 participantsStarted 2017-08-30
Plain-language summary
The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).
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.
Key Inclusion Criteria:
* Subjects with 2-8 moderate to severe migraines/month
* Age of onset of migraines prior to 50 years of age
* Migraine attacks, on average, lasting 4-72 hours if untreated
* Ability to distinguish migraine attacks from tension/cluster headaches
* Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria
Key Exclusion Criteria:
* History of basilar migraine or hemiplegic migraine
* History of HIV disease
* History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia.
* Uncontrolled hypertension or uncontrolled diabetes (however, patients can be included who have stable hypertension and /or diabetes for 3 months prior to screening
* History of gastric or small intestinal surgery or has a disease that causes malabsorption
* BMI ≥ 30
* HbA1c ≥ 6.5%
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
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
Timeframe: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
2
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Timeframe: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks