Migraines are a common condition. It’s estimated that more than 38 million Americans and 1 billion people around the world get migraines. A migraine is no ordinary headache. It brings intense, throbbing pain, along with other symptoms like nausea and sensitivity to light and sound. These symptoms can be severe enough to interfere with your life.
If you’ve tried just about every migraine medicine and still haven’t found relief, you may have another option. Hundreds of clinical trials going on right now around the country are testing new migraine therapies. One or more of these treatments could revolutionize the way doctors care for migraines. By participating in a clinical trial, you could get access to a breakthrough migraine treatment months or years before it becomes available to the public.
Clinical trials and migraines
Migraines can be disruptive and life altering. According to the Migraine Research Foundation, they’re the sixth most disabling condition in the world. Migraines are considered chronic if you have more than 15 migraine days out of each month. More than 4 million people get chronic migraines. For many of these people, the pain and other symptoms are so severe that they have to lie down in a dark, quiet room whenever a migraine strikes.
A few different migraine medicines are available, but no current treatment can cure these headaches. The medications focus on treating migraine symptoms or preventing the migraine from beginning. Some people have tried drug after drug without finding any relief.
If you’re one of these people, you do have another option—a clinical trial. Researchers use these studies to test out new, more targeted migraine treatments. By enrolling in a trial, you can get access to a potentially more effective migraine therapy.
How to join a clinical trial
Many clinical trials across the country and around the world are studying new migraine treatments. These studies are being conducted at university medical centers, government agencies, and drug companies.
To find a study, you have a few options:
- Ask the doctor who treats your headaches if they know of any open migraine studies in your area.
- Call university hospitals near you and see if they’re taking part in any migraine trials.
- Search online.
There are a few helpful websites for finding a study:
- ClinicalTrials.gov is a database of studies run by the U.S. National Institutes of Health. To find the right study, search by the condition and your location. For example, you could type in “Migraines” and “Chicago.”
- CenterWatch lets you search clinical trials and sign up to get email notifications when a migraine trial opens up.
- Researchmatch.org matches you with open studies.
To participate in a clinical trial, you’ll need to meet the study qualifications. The researchers usually have criteria for participants, which can include:
- your age
- your gender
- your weight
- the number of headaches you get each month
- the medicines you take or medications you’ve tried for your migraines in the past
- any other health conditions you have
You’ll need to meet all of the qualifications to enroll in the study. Meeting these criteria ensures the most accurate results.
Even if you’re accepted into the study, you don’t have to participate. Make sure you understand the treatment and how it might help or hurt you before you sign on.
What to expect during a clinical trial
Before you start the study, you’ll have to sign an informed consent form. By signing this form, you’ll show that you understand the purpose of the study, along with its benefits and risks.
To be sure you know what to expect during the clinical trial, it’s a good idea to ask the researchers these questions:
- What is the purpose of the study?
- What treatments will be used in the study?
- What are the possible benefits of these treatments?
- What are the risks?
- Will I be paid for my time?
- Will I have to pay for my care? If so, will my insurance cover the cost?
- Will I have to stay in the hospital, or can I just come in for the treatment?
- For how long will the study last?
- What can I do if I have side effects from the treatment?
One of the doctors will give you an exam and review your medical history before you start. If you’re accepted into the trial, then you’ll be assigned to a study group.
If you’re in the treatment group, you’ll get the migraine drug that’s being studied. If you’re in the control group, you’ll get an older medicine, or an inactive pill called a placebo.
If the study is blinded, you won’t know which group you’re in. The medical team also might not know which treatment you’re getting.
Migraine studies are conducted in three phases:
- Phase I studies are small. They usually have fewer than 100 volunteers. At this stage, researchers want to learn how much of the treatment to give participants, and whether it’s safe.
- Phase II studies are done when the drug’s safety has been confirmed. They’re usually larger, with 100 to 300 volunteers. At this stage, researchers want to learn more about the treatment’s safety and the correct dosage.
- Phase III studies are even bigger. They compare the new treatment to an existing treatment to see if it’s more effective.
- Phase IV studies are done after the drug is approved to learn more about it.
Studies can be inpatient or outpatient. During inpatient studies, you’ll stay overnight in the hospital for part or all of the treatment period. During outpatient studies, you’ll only go to the hospital to receive the treatment. You may have to go in for check-ups with the study doctors to see how you’re responding to the treatment and whether you’re having any side effects.
Often you’ll get paid for the treatment and care you get as part of the trial. You might also be compensated for your time and travel costs.
What are the benefits of clinical trials?
When you take part in a clinical trial, you’ll get access to a new migraine treatment before it’s available to the public. This new treatment may be better than anything that’s currently available.
Here are some other benefits to participating:
- You’ll be under the care of a highly trained team of medical professionals who are experts in migraine treatment.
- You may get your treatment for free. You might also get paid for your time and travel.
- What the researchers learn from your involvement could benefit many other people around the world.
What are the risks associated with clinical trials?
Medical studies do have some risks and downsides, for example:
- The new treatment might not work any better than existing treatments or it might not work for you.
- The treatment could cause side effects the researchers didn’t expect. Some side effects can be serious or life-threatening.
- You might get a placebo instead of the active treatment.
- You’ll have to invest time to go to doctor’s appointments and get treatments.
- The study might not cover all of your medical costs. If you have to pay for some of your treatment, your insurance company might not cover that cost.
If your current migraine treatment isn’t working, a clinical trial can be a way for you to try a new and possibly more effective therapy. Though a study can have risks, you always have the right to leave if you aren’t happy with the results, or if the treatment causes side effects.
Migraines vs. headaches
Approximately half of all people with migraines are never diagnosed. A migraine is no ordinary headache, so headache treatments usually won’t work for migraines. This is why it’s important to see your doctor if you think you may have migraines. Once you’ve been diagnosed, you can work with your doctor to find a treatment plan or a clinical trial.