A Research Study To Evaluate If Frovatriptan Is Safe And Effective In Preventing Migraine Headache After Fasting

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