Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT00440232
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects between the ages of 18 and 65, inclusive
* Subjects diagnosed with episodic migraine, with or without aura according to IHS criteria for at least one-year prior to screening
* Subjects who experience between 1 and 6 migraine attacks per month inclusive (during the previous 6 months) with no more than 15 days of headache per month.
* Subject reports hunger or fasting as a known trigger for migraine
* Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
* Subjects who are able to understand and comply with all study procedures.
* Subject is willing to complete one 20-hour fast, starting between 5:00 and 8:00 P.M., with no food or drink (except water needed to take routine medication)
* Subject provides written informed consent prior to any screening procedures being conducted
* If subject is taking a preventive migraine medication for migraine or any other reason, that medication must have been a stable dose for at least 4 weeks prior to screening, and must remain stable throughout the duration of the study.
EXCLUSION CRITERIA
* Pregnant and/or lactating women
* Subjects who have a history of clinically relevant allergy to frovatriptan or like compounds
* Subjects who, in the investigators opinion, have a history or have evidence of any other medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
* Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
* Subjects who currently have or have a history of significant cerebrovascular disease including basilar or hemiplegic migraine
* Subjects who have a history of non-response to triptans, as determined by investigator
* Subjects with uncontrolled hypertension
* Subjects with diabetes mellitus who require insulin or oral anti-hyperglycemic agents will be excluded. (Subjects with Type II diabetes who are well controlled with diet and exercise alone may be included.)
* Subjects who currently have or who have a history of ischemia and/or vasospastic coronary artery disease
* Subjects who, in the investigators opinion, have significant risk factors of coronary artery disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00440232
Study Brief:
Protocol Section:
NCT00440232