TerminatedNot Applicable

Frovatriptan and Menstrual Migraine

Stopped: A sister study using Frova at a 10 mg dose had adverse effects.

United States24 participantsStarted 2010-04

Plain-language summary

We are looking for women who suffer from menstrual migraine to participate in a 2-visit migraine brain imaging research study. Our goal is to see how the menstrual migraine brain's pain pathways function when the migraineur has been taking Frovatriptan. During the screening visit (Visit 1) participants will sign the informed consent form, complete questionnaires, meet with the study physician, and have QST (quantitative sensory testing: to determine your pain thresholds for a heat stimulus) performed. For Visit 2's MRI scan, subjects will be asked to lie very still while the scan is occurring. In some parts, they will not have to do anything, while in others they will be asked to rate pain and unpleasantness for brush and thermal stimuli. Participants are compensated for both visits.

Who can participate

Age range

18 Years

Sex

FEMALE

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: * Female * Regular Menstrual Phase * Menstrual Migraine * No significant medical history (Significant medical history of such as seizure disorder, diabetes, alcoholism, cardiac disease including coronary artery disease, psychiatric problems; drug addiction, respiratory problems, liver disease, etc.) * No significant medication history, except for migraine * All patients will be currently taking or have previously taken triptan medications for migraine * Weight, \<285 pounds * Not claustrophobic * No contraindication to taking triptans Exclusion Criteria: * Age \<18 * Significant medical problems (aside from pain before, during and after migraine episodes) * Positive drug of abuse screen (excluding medications currently prescribed for their clinical condition, e.g. opioids, benzodiazepines, etc.) * Positive alcohol screen * Women taking oral contraceptives * Claustrophobia * History of dermatological hypersensitivity in the facial area * Positive history of cardiac problems/ abnormalities seen in EKG at initial screening visit * Pregnancy * Sensory loss detected on Quantitative Sensory Testing at screening * Significant alcohol history (ingestion of 5 or more glasses (\> 40 oz) of alcohol per week) * Metal implants of any type (including dental bridges, crowns, retainers, orthodontic devices e.g. braces, etc.) * Tattoos containing metallic ink on the neck, shoulders, upper arm and head (which could become heated up in the scanner, and potentially cause b…

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.

Trial details

NCT IDNCT01114711

SponsorMclean Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-05

View on ClinicalTrials.gov More Frovatriptan trials