After decades of neglect, scientific researchers and pharmaceutical companies are finally giving migraine the attention it deserves. In just the past few years, several new migraine treatments have hit the market (think: anti-CGRP treatments, Nerivio™, Reyvow™, Nurtec™, and other recent innovations), ending the long lull in new discoveries after triptans were developed in the 1980s.
If you’re keeping up with the news, you’ve probably noticed that every new treatment announcement mentions a study proving that the drug works. But how can you know which studies are legit? And if none of the migraine treatments that are currently available work for you, how can you get involved in one of these studies to see if the drug works for you?
To help answer these questions, we spoke to Dr. Detlef Albrecht, MD, Chief Medical Officer at Satsuma Pharmaceuticals, a biopharmaceutical company currently developing a new acute migraine treatment.
What is a medical study?
Let’s start with the basics: What do we actually mean when we say “study”? Put broadly, a medical study uses human volunteers with a specific condition or disease to perform research and to add to medical knowledge. There are two main types of medical studies: clinical trials and observational studies.
Clinical trials
In a clinical trial, the aim of the study is to determine the effectiveness and safety of a particular treatment (that doesn’t just mean medication—studies can also look into lifestyle interventions, such as diet changes, or medical devices). This might involve comparing two existing treatments, or comparing one treatment to a placebo or no treatment at all. Researchers usually do this by randomly sorting participants into groups, giving each group a particular treatment, and then tracking the results.
Observational studies
Observational studies, as the name suggests, are a lot less hands-on. In an observational study, the researchers don’t give specific treatments to the participants. Instead, they just track the results of whatever treatments the participants are already using. Observational studies are especially useful for discovering how different lifestyles impact people’s health in the long term.
If you’re hoping to try out a treatment that hasn’t hit the market yet, then you’d want to be on the lookout for clinical trials rather than observational studies.
How do I know if a study is legitimate?
Let’s say you find a clinical trial that sounds interesting. How do you know if it’s safe to participate in?
The first place you should go is ClinicalTrials.gov, a database of clinical studies maintained by the government. Any U.S.-based study focused on migraine sufferers is required to be registered on that site, so check it out before pursuing any study opportunities you come across.
Once you find a study you’re interested in, you should reach out to one of sites where it’s being conducted (they should be listed on ClinicalTrials.gov) or one of the people administering it. As part of what’s known as the Informed Consent procedure, they’ll tell you how the study works, including how many times you’ll have to visit the site and what tests they’ll need to perform. They’ll also explain the potential benefits and side effects of the treatment they’re researching.
If you still have concerns after that, you can try to get in touch with their Institutional Review Board (IRB), an administrative body that protects the rights of research participants. Each study site has its own IRB, so you’ll need to ask someone at the site for the correct contact information.
How do people get chosen to be in a study?
You might think you already know the answer to this one if you’ve ever spotted an ad seeking participants for a study online or on TV. Surprisingly, “a lot of studies are done without any advertisement,” Dr. Albrecht says.
Why? Often it’s because the researchers don’t need ads to find people with the condition they’re studying. For example, if you’re working at a cancer center, you don’t need to look far to find participants for a cancer treatment study. And if what you’re researching is very specific, widespread advertising might not make pay off.
On the other hand, Dr. Albrecht says, “Conditions that allow self-identification, such as migraine headaches, are good targets for advertisement campaigns.”
Am I eligible for a study about migraine?
As you might guess, that depends on the study. Every clinical study has a set of standards that you have to meet in order to participate, called “eligibility criteria.” These can include suffering from a particular condition (or being healthy), being a certain age or gender, or having a specific treatment history.
If you’re a migraine sufferer looking to participate in a migraine study, you already meet at least one of the criteria. According to Dr. Albrecht, another common requirement is having a particular number of attacks of a certain severity each month. Depending on how many headaches you get, you could be eligible for an acute treatment study or a chronic prevention study.
Every study determines its own eligibility criteria, so the only way to find out if you’re eligible for a particular study is to apply and see what happens.
What are the downsides to being in a study?
This will also vary from one study to the next, but the most obvious downside is the potential side effects of the treatment being studied. Researchers are required to inform you of any known side effects before you join the study. That said, these are experimental treatments, so the researchers might not be aware of all the adverse effects.
Signing up to try a treatment that hasn’t been thoroughly tested is a risk you shouldn’t take lightly. If you have any concerns, it’s always a good idea to have a talk with your doctor.
What have been some successful recent studies?
“Amazingly, we have seen three new drugs approved for the acute treatment of migraine over the past few months,” Dr. Albrecht says, “Reyvow (lasmiditan), Ubrelvy (ubrogepant), and Nurtec (rimegepant).”
The FDA won’t give their approval to a medication that hasn’t been thoroughly studied, so each of these new drugs was supported by successful studies. If you’re interested, you can take a look at the clinical data behind Reyvow, Ubrelvy, and Nurtec.
What are the current studies happening for new migraine treatments?
Now that scientists are finally giving migraine the attention it deserves, there are too many exciting studies going on to list. For the most up-to-date information about clinical studies happening near you, just search ClinicalTrials.gov.
Here are a few studies happening right now:
Prevention treatment and productivity
This study will find out if sufferers of episodic migraine perform better at work while using a new preventive anti-CGRP treatment, Aimovig® (branded erenumab).
IV treatment for acute migraine attacks
This study tests another anti-CGRP treatment, Vyepti™ (branded eptinezumab). Vyepti™ is an acute treatment delivered intravenously.
New type of acute treatment
This study is investigating an acute treatment that’s the first of its kind: lasmiditan, a.k.a. Reyvow™. The study’s happening in 12 states and several countries outside the U.S.
Non-invasive preventive
These researchers are seeking migraine sufferers to help test out a non-invasive electrical device called GammaCore that stimulates the vagus nerve.
Neurostimulation
This study is evaluating the effectiveness of another type of electrical stimulation. Transcranial direct current stimulation (tDCS) provides targeted stimulation to the brain to change the behavior of neurons.
Heart rate app
This study isn’t testing a new drug or device. Instead, it focuses on a smartphone app that teaches users how to lower their heart rate through breathing exercises. The researchers are hoping to determine if regular use of the app improves the participants’ quality of life.
Volunteering to help test out an experimental treatment is a decision that shouldn’t be taken lightly. But every migraine sufferer benefits when a new treatment option hits the market, and those breakthroughs wouldn’t be possible without study participants. And for sufferers who’ve tried everything without success, the risk could be well worth the chance to find relief.
Looking to try out a new treatment without having to participate in a study? Cove offers over 20 different clinically-proven migraine treatments. A Cove doctor can help you figure out what’s best for you.
The information provided in this article is not a substitute for professional medical advice, diagnosis, or treatment. You should not rely upon the content provided in this article for specific medical advice. If you have any questions or concerns, please talk to your doctor.
Nerivio should not be used by people with congestive heart failure, severe cardiac or cerebrovascular disease, or uncontrolled epilepsy. Nerivio should not be used by anyone with active implantable medical devices (e.g. pacemaker, hearing aid implant). It should only be applied on the upper arm over dry, healthy skin with normal physical sensation. Nerivio should not be used directly over or in close proximity to any metallic implants or cancerous lesions. Nerivio has not been evaluated in pregnancy or those under the age of 18. For full use instructions and safety information, please see the Nerivio User Manual. Click here for the QuickStart guide.
Nurtec ODT (rimegepant) orally disintegrating tablets is a prescription medicine for the acute treatment of migraine attacks with or without aura in adults. Nurtec ODT is not used as a preventive treatment of migraine. It is not known if Nurtec ODT is safe and effective in children. Do not take Nurtec ODT if you are allergic to Nurtec ODT (rimegepant) or any of its ingredients. Before you take Nurtec ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you: are pregnant or plan to become pregnant; breastfeeding or plan to breastfeed. Tell your HCP about all the medicines you take. Nurtec ODT may cause serious side effects including allergic reactions, including trouble breathing and rash. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing.Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088 or report side effects to Biohaven at 1‑833‑4Nurtec. Please click here for full Prescribing Information and Patient Information.
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