If you qualify and choose to participate you will receive all study-related care at no cost and will also be compensated for your time and travel to attend required study visits.
What is the purpose of a clinical study?
Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical trials.
Has the investigational drug been used before?
The active ingredient in TNX-1900 has been used in previous clinical studies for chronic migraine and is currently used in other non-migraine medications that have been approved by the FDA.
How many people will participate in the study?
The study will enroll up to 300 participants who suffer from Chronic Migraine at approximately 25 study centers throughout the U.S.
Will I have to pay for anything if I choose to join the study?
No, participants in the PREVENTION Study will receive all study-related care and study drug at no cost. Health insurance is not required to participate.
Does everyone in the study receive the investigational drug?
No, as part of the study, participants will be randomly assigned (like flipping a coin) to take either two doses of the investigational drug a day (33% chance), one dose of the investigational drug and one dose of placebo drug a day (33% chance), or two doses of a placebo drug a day (33% chance). The placebo drug looks just like the investigational drug but has no active ingredient. Neither you nor your doctor will know which drug you receive. This is a common technique in clinical studies, as it helps doctors and researchers understand the effects of the investigational drug without bias.
How long does the study last?
The study lasts about 5 months. During this time, you will visit your study doctor’s office up to 6 times (approximately once a month). These visits are an important part of the study, as they allow your study doctor to closely monitor your health and symptoms, as well as discuss your overall experience.
What happens during the visits?
Before you decide to participate, your study team will provide you with a detailed summary of what will happen at each visit so that you can make an informed decision about joining the study.
At your first visit (the Screening Visit), your study doctor and staff will review your medical history and migraine symptoms to confirm if you are eligible to join the study. You will also receive a routine physical exam, electrocardiogram (ECG), and will have blood and urine samples collected to assess your general health. The doctor will discuss any medication restrictions with you and may discuss the need for a medication wash-out.
If you are eligible and decide to move forward, the study staff will assist in setting up the eDiary application at Visit 1, which marks the start of the eDiary “run-in” phase. If you remain eligible after the eDiary run-in phase, you will return to the clinic for a Baseline Visit (Visit 2) where you will be provided with study drug and instructions to follow during the treatment period. You will return to your study doctor’s office 4 more times over the next 3 months to evaluate your progress and monitor your health. During the treatment period (Visit 2 through Visit 5), you will continue to complete eDiary questions on a daily basis until study participation is complete. After you complete the treatment period, you will have 1 additional follow-up visit.
What if I join the study and decide I do not want to participate anymore?
As with all clinical studies, your participation is completely voluntary. You may leave the study at any time without any effect on your future medical care.