A Double Blind Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Frov… (NCT00821483) | Clinical Trial Compass
CompletedPhase 3
A Double Blind Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Frovatriptan in the Acute Treatment of Migraine
298 participantsStarted 2006-11
Plain-language summary
The purpose of this study is:
1. To compare the efficacy of a single dose of Frovatriptan 2.5 mg with that of placebo in acute treatment of up to one migraine attract
2. To assess recurrence rate between two group
3. To assess the safety and tolerability
Who can participate
Age range
18 Years – 65 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
. Adults aged 18 to 65 years
. The patients must have a history of migraine according to the criteria of the Headache Classification Committee of the International Headache Society(IHS), over the previous 1 year. The patient must have experienced one to eight moderate or severe migraine attacks(with or without aura) each month over at least the previous two months
. Onset of migraine disease must have occurred before the patients was 50 years of age
. Able and willing to sign informed consent, and able and willing to comply with study procedures, including the completion of diary cards.
Exclusion criteria
. Pregnant or lactating females, or women intend to become pregnant or breast feed during the study period, or women of childbearing potential not using adequate contraception. Females of reproductive potential must have a negative pregnancy test at screening
. Clinically significant renal dysfunction(creatinine≥2.0mg/dl) or hepatic dysfunction(ALT,AST≥2 ULN)
. Patients with clinically significant abnormal ECGs or with resting diastolic blood pressure above 95mmHg
. Patients with clinically significant cardiovascular or cerebrovascular disease
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
A comparison between Frovatriptan and placebo for the proportion of patients who have complete(grade 0) or almost complete(grade 1) relief of headache at 2 hours after taking Frovatriptan