Migraines—a neurological disorder that cause intense headaches lasting for hours or days—is an extremely common condition. Because migraines are so debilitating, causing many days of disability throughout the lifetime of individuals who are affected by them, research continues to identify ever more effective treatments.
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What Are the Current Treatments for Migraines?
Migraine treatments are generally divided into two categories, preventative and acute.2-4 Acute treatments are intended to reduce the intensity and duration of a current headache. Preventative treatments are taken regularly and help reduce the frequency of migraines and the intensity of headaches before they occur.
Current Migraine Research
For decades, migraine therapies have largely been adopted from existing medications. These existing medications had migraine added as an indication after clinical trials confirmed their safety and effectiveness in treating migraines. Of the current treatments for migraine, only triptans and one ergot drug were purpose-built for migraine care.5
This state of affairs, however, is set to change with new drugs on the horizon. Clinical researchers are taking several approaches to developing new migraine treatments:
- Some target mechanisms are already exploited by existing drugs, but they are trying to improve these by maximizing efficacy while minimizing side effects.
- Other approaches use the therapeutic activities of biomolecules like antibodies to provide lasting relief with low dosage.
- Technological advances are accelerating the development of new non-pharmaceutical neurostimulation techniques and applying existing technologies to new audiences.
- Researchers are developing techniques to help patients manage their symptoms through mindfulness techniques and alternative therapies, potentially bringing new, affordable therapies to patients.
Current Clinical Trials for Migraines
A small protein called calcitonin gene-related peptide (CGRP) plays an important role in blood vessel changes that are associated with migraines.5 To act, it must bind with a protein called the CGRP receptor. By blocking the CGRP receptor, a drug could stop its functioning and potentially prevent migraines or reduce their severity when delivered during an active episode.
Gepants are a class of drugs that target the CGRP receptor in the trigeminal nerves, which are activated during migraine headaches.5 By blocking the receptor, gepants reduce the nerve’s activation and prevent or reduce headache pain.
There are currently three gepants approved for use in the U.S.: ubrogepant, rimegepant, and atogepant. However, due to their newness, clinical trials are ongoing to solidify their safety and efficacy and expand their use to broader populations. For example, one current trial is investigating the long-term safety of atogepant in both chronic and episodic migraines.6 Two clinical trials in Japan are studying the efficacy of rimegepant as a preventative treatment while another in China is examining the drug’s long-term safety.7-9
Expanding the indications of existing drugs is critical to broadening access to all patients. Two trials are studying the effects of ubrogepant on children ages 6 to 17, bringing the drug to patients at the age when migraines typically first emerge.10-11
Finally, the drug zavegepant is approved by the U.S. Food and Drug Administration (FDA) as a nasal spray for acute migraine relief. An oral version of zavegepant is currently being studied as a preventative therapy.12
Antibody-Based Therapies for Migraines
In addition to gepants, antibody-based therapies are used to target CGRP activity, both in the clinic and in research. The majority are monoclonal antibodies, which latch onto one specific part of their target molecule. For example, erenumab, approved by the FDA in 2018, is undergoing further investigation for high-frequency migraines.13 To supplement its approval and support the drug’s cost-effectiveness, another study is investigating patient satisfaction with the drug.14
Also approved in 2018, fremanezumab is currently only indicated for adults. At least two clinical trials to expand the indication to children ages 6 to 17 are ongoing and still recruiting participants.15-16
Other Pharmaceuticals for Migraines
The seizure drug lacosamide is currently being studied for its ability to reduce migraine frequency by acting on CGRP.17 Another trial is seeking to expand the indication of extended release form of topiramate (Qudexy® XR), another anti-seizure drug, to children ages 6 to 11 years.18
Botulinum toxin type A, commonly known as Botox, has a potent ability to block nerve activity and is being investigated for drug-resistant migraine treatment.19
Finally, one novel clinical trial is applying probiotics, a form of gastrointestinal bacterial supplements, in combination with other treatments.20
Neurostimulation for Migraines
Neurostimulation techniques provide a non-pharmaceutical pathway toward migraine relief. Multiple ongoing clinical trials are investigating novel neurostimulation protocols and applying existing ones to new demographics.
For example, one actively recruiting study is testing a novel neuromodulation device for children experiencing acute migraine episodes.21 Another trial is combining ultrasound-guided nerve blocks with pulsed radiofrequencies applied once weekly.22 Finally, the use of transcranial direct current stimulation (tDCS) is under investigation for use in combination with physical therapy.23
Mindfulness and Psychological Interventions for Migraines
There are also several ongoing trials examining psychological interventions for migraines. Acceptance and commitment therapy (ACT) is being tested as an intervention to help migraine patients better cope with their symptoms.24
The psychological effects of migraines and the personality traits that affect them are currently poorly understood. To this aim, a study is investigating the psychological impact of severe, difficult-to-treat migraines.25 Similarly, another actively recruiting trial is examining the impact of pain resilience on the psychological well-being of people with migraines.26
Enrolling in Clinical Trials for Migraine
Find Clinical Trials Near Me
Interested in clinical trials? Simply search by postal code and type of condition to see what’s going on in your area.
By participating in clinical trials, you can help advance migraine care and perhaps find a solution to help you manage your migraines more effectively.
Each clinical trial will typically have inclusion and exclusion criteria for its participants. Inclusion criteria are the characteristics you must have to join the trial. These could be features about you like your age, whether you have migraines, or what kind of migraines you have. Exclusion criteria are features that prevent you from joining a particular trial. If you have any of the specified traits in the exclusion criteria, you cannot participate. These criteria are important for researchers to yield usable data to answer their research questions and to help safeguard participant health and safety.
Before deciding whether to participate in a clinical trial, take time to weigh the benefits and risks. Talk with your close family members, friends, and your doctor to decide if a clinical trial is right for you. The decision should be made with your health and best interests in mind.