This research study is evaluating an oral study drug for menstrual migraine in adults. You may be able to take part in this study if you:
The study will involve 13 study visits over the course of up to 84 weeks. There is a screening period (up to 16 weeks) to determine if you qualify to enroll in the study. Once enrolled in the initial study treatment period (up to 16 weeks), participants will be randomly assigned to 1 of 2 groups and will receive either the active study drug or a placebo (a substance that looks like the active study drug but contains no active ingredients), both taken orally (by mouth) for 7 consecutive days in each menstrual cycle.
Those who complete the initial study treatment period may then be able to enroll in a study extension period, which will last for 1 year. All participants will receive the active study drug during this period.
The study drug is an oral tablet that has been FDA approved for the acute treatment of migraine in adults, and in this study, it is being evaluated for the prevention of menstrual migraine (a use that has not been approved).
Do not discontinue any drugs unless you are advised to do so by the study clinic staff or your primary care provider.
There is no cost to you for participating in the study.
Clinical research studies are designed in specific ways, and one or more of the answers that you provided were outside of the guidelines for this study. This does not mean you will not qualify for different research studies.
This research study is evaluating an oral study drug for menstrual migraine in adults. You may be able to take part in this study if you:
The study will involve 13 study visits over the course of up to 84 weeks. There is a screening period (up to 16 weeks) to determine if you qualify to enroll in the study. Once enrolled in the initial study treatment period (up to 16 weeks), participants will be randomly assigned to 1 of 2 groups and will receive either the active study drug or a placebo (a substance that looks like the active study drug but contains no active ingredients), both taken orally (by mouth) for 7 consecutive days in each menstrual cycle.
Those who complete the initial study treatment period may then be able to enroll in a study extension period, which will last for 1 year. All participants will receive the active study drug during this period.
The study drug is an oral tablet that has been FDA approved for the acute treatment of migraine in adults, and in this study, it is being evaluated for the prevention of menstrual migraine (a use that has not been approved).
Do not discontinue any drugs unless you are advised to do so by the study clinic staff or your primary care provider.
There is no cost to you for participating in the study.
Clinical research studies are designed in specific ways, and one or more of the answers that you provided were outside of the guidelines for this study. This does not mean you will not qualify for different research studies.
