Our research study is evaluating how well the investigational study drug, prevents menstrual migraines in adult women compared to placebo.
Those who qualify and choose to participate may be compensated for 13 visits over approximately 84 weeks.
This study is looking to see if the study drug, is safe, effective, and well tolerated for preventing menstrual migraines when taken for 7 days in row starting 3 days before the start of your period. The study drug is currently approved to treat other medical conditions and is now being studied for menstrual migraine.
If you qualify and choose to participate, there is a 50% chance you will receive the study drug and a 50% chance you will receive a placebo. A placebo is an inactive material that looks like study drug but does not contain any active ingredient.
You will be on this study for about 84 weeks which will include a screening period, a treatment period, and an open-label extension period. The study will require up to 13 in-clinic visits. If you qualify and choose to participate, you may be compensated for your study-related time and travel. Your participation is entirely voluntary, and you can leave the study at any time.
Those who qualify and choose to participate could receive:
Access to the study drug or placebo, at no cost
Access to our top-tier team of board-certified physicians for study related care at no cost
A research study or clinical trial is the process a potential new drug, device, procedure, or process goes through to prove that it is safe, tolerable and effective for the condition it is being studied for. Research studies are the only way to advance medicine for future generations.
Each study has its own set of inclusion and exclusion criteria that a participant must meet before they are allowed to participate in a study. Patients from all backgrounds and walks of life are encouraged to participate.
Every participant in every research study must go through the informed consent process. During this, the trial doctor and research team go over what will happen in the study, what treatments you might get, how long the trial is expected to last, what happens during visits, the potential risks and benefits, and many other important facts about the study. Participants may withdraw their consent and discontinue the study at any time for any reason.
A placebo looks like a treatment but does not have any active medicine in it. Researchers use placebos to help make sure any changes in the participants’ health are actually caused by the study treatment. You do not get to choose if you get the study treatment or the placebo, and you may not know if you get the placebo until after the study. Not all research studies use a placebo.
If studies do not include diverse participants, we cannot know if treatments work for everyone who needs them. Studies only tell researchers how something works for the participants of that study, and they may not work the same in people of different races, ethnicities, ages, or sexes.
All research studies must follow federal laws and ethical guidelines, including HIPAA. Studies must also be approved by an expert group called an institutional review board (IRB) that helps make sure the trial is fair and as safe as possible, and that any risks to the participants are worth the potential benefits.