Before a new treatment for migraine, cluster, or other headache diseases can reach patients, it must be approved by the Food and Drug Administration (FDA). The FDA evaluates results from clinical trials to determine whether a potential treatment is both safe and effective. Clinical trials cannot move forward without patients enrolled.
We answered some common questions about participating in headache disease research below. If you’re interested in finding a clinical trial, answer a few questions to get started using our Antidote trial matching tool.
How do I find headache disease clinical trials near me?
All clinical trials are listed on ClinicalTrials.gov, but because the website was designed for researchers rather than for patients, the listings can be difficult to understand for those without a medical background. If your doctor isn’t aware of any trials that may be right for you, you can also use trial search tools to find potential matches. Antidote created a tool specifically for patients: simply answer a few questions about your headache disease and receive a list of trials you may qualify for in your area. Then, you can reach out to the people running the trial for more information.
I experience migraine or cluster attacks many times a month. Are there clinical trials for me?
Every clinical trial has different inclusion and exclusion criteria to determine who qualifies. Clinical trials for migraine, cluster and other headache diseases may require patients to experience a certain number of attacks over a period of time. Trials may also require you to have taken, or not taken, certain medications. Those requirements vary from trial to trial, so if you don’t meet the requirements for one trial, there may be another option that’s right for you.
My child has a headache disease. Are there clinical trials available for children?
Some clinical trials do look for pediatric patients to take part. Of course, in order for a child under 18 to take part in a trial, a parent or guardian must give consent as well. Studies that involve children also have additional protections from the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). Research suggests that children’s brains respond differently to medication than adult brains do, which is one reason clinical trials specifically for children are important.
What are the benefits and risks of joining clinical trials for headache diseases?
The benefits of joining a clinical trial include the opportunity to access a potential new treatment, receive care from headache disease experts, and help move research forward. The risk in any clinical trial is that the treatment won’t work for you, you’ll receive a placebo, or you’ll experience unwanted side effects from the treatment. When you’re considering taking part in a trial, talk with your doctor to help decide if it’s the right option for you.
How do researchers decide who gets a placebo in clinical trials?
The FDA considers double-blind, randomized clinical trials to be the most reliable methods of determining whether or not a treatment is safe and effective. In these trials, neither the patients nor the researchers involved in a study know which patients are receiving the investigational treatment, and which are in the control arm of the study. A computer assigns patients to an arm of the study at random.
Not all clinical trials, however, use a placebo. Some trials measure the effectiveness of a potential new treatment against the existing standard of care. A trial may also be structured so that all patients receive the active treatment at some point during the study. If you’re interested in a clinical trial, the study team can explain the structure of how the trial will work.
What if the treatment has bad side effects?
Before joining a clinical trial, the study team will tell you about any side effects of the potential new treatment that have been experienced. Side effects are always a risk, but know that clinical trial participants are always free to leave a trial at any time, for any reason.
It’s also important to note that not all headache research investigates potential new medications. Some studies research the impact of diet on migraine disease, for example, or behavioral cognitive therapies for cluster headaches. Non-medication treatments can still have side effects, however, so it’s always important to ask any questions you have about the treatment before joining a trial.