Migraine Clinical Trials

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.

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.

Last updated: 01/09/2024Last medically reviewed: 07/05/2023

Medical Disclaimer: The information provided in this article is not a substitute for the advice of qualified healthcare professionals. While we strive to publish accurate information, it is not possible to cover all potential scenarios, including drug or treatment effects, interactions, or usage. You should not rely solely on this article to determine whether a particular treatment, drug, or clinical trial is suitable for you or any other individual. Always consult a healthcare professional before starting or changing any treatments.


  1. Pescador Ruschel MA, De Jesus O. Migraine Headache. 2023, Treasure Island (FL):       StatPearls Publishing: StatPearls [Internet].
  2. Shankar Kikkeri N, Nagalli S. Migraine with Aura. 2023, Treasure Island (FL): StatPearls Publishing: StatPearls [Internet].
  3. Lew C and Punnapuzha S. Migraine Medications, in StatPearls. 2023: Treasure Island (FL).
  4. Ong JJY and De Felice M. Migraine Treatment: Current Acute Medications and Their Potential Mechanisms of Action. Neurotherapeutics, 2018. 15(2): p. 274-290.
  5. Johnson B and Freitag FG. New Approaches to Shifting the Migraine Treatment Paradigm. Front Pain Res (Lausanne), 2022. 3: p. 873179.
  6. ClinicalTrials.gov. A Phase 3, Multicenter, Open-Label 156-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for The Prevention of Migraine in Participants with Chronic or Episodic Migraine. March 23, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT04686136
  7. ClinicalTrials.gov. Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects. April 10, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05399459
  8. ClinicalTrials.gov. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Japanese Subjects. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05399485
  9. ClinicalTrials.gov. BHV3000-318: A Multicenter, Open Label, Long-Term Safety Study of BHV3000 for the Acute Treatment of Migraine in Chinese Subjects. March 2, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05371652
  10. ClinicalTrials.gov. A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine with or Without Aura in Children and Adolescents (Ages 6-17). January 19, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05127954
  11. ClinicalTrials.gov. A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine with or Without Aura in Children and Adolescents (Ages 6-17). April 21, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05125302
  12. ClinicalTrials.gov. A Phase 2/3 Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention. March 29th, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT04804033
  13. ClinicalTrials.gov. Comprehensive Assessment of Erenumab Efficacy in Subjects with High Frequency Episodic Migraine with at Least 1 Previously Failed Preventive Treatment: a Global, Double-blind, Placebo-controlled Phase 4 Study. March 17th, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT04252742
  14. ClinicalTrials.gov. Phase 4, Open-label Study to Evaluate Treatment Satisfaction with Erenumab in Patients with Migraine. March 2, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT04825678
  15. ClinicalTrials.gov. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age. March 28, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT04458857
  16. ClinicalTrials.gov. A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age. March 28, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT04530110
  17. ClinicalTrials.gov. A Randomized Pilot Study of Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients. April 18, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05632133
  18. ClinicalTrials.gov. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 4 Study to Evaluate the Efficacy and Safety of Qudexy(R) XR in the Prevention of Migraine in Children 6 to 11 Years of Age. December 22, 2022. Accessed from: https://clinicaltrials.gov/ct2/show/NCT04748601
  19. ClinicalTrials.gov. Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine. December 6, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT04069897 .
  20. ClinicalTrials.gov. The Effectiveness and Tolerability of Multi-Strain Probiotics as Adjunctive Preventive Treatment of Episodic Migraine: A Single Centre, Randomised, Double-Blind, Sham-Controlled Phase 2 Trial (PROBIOTICS -EM). November 3, 2022. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05042037
  21. ClinicalTrials.gov. A Pilot Clinical Trial of a New Neuromodulation Device for Acute Attacks of Migraine in Children and Adolescents Visiting the Emergency Department. March 16, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05102591
  22. ClinicalTrials.gov. Comparison of Transcutaneous Pulsed Radiofrequency Therapy and Greater Occipital Nerve Block Efficiency in Migraine Headache.February 3, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05499689
  23. ClinicalTrials.gov. Effects of tDCS and Physical Therapy on Pain in Women with Chronic Migraine: A Factorial Clinical Trial Randomized, Blinded. January 31, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05706077
  24. ClinicalTrials.gov. Acceptance and Commitment Therapy for High Frequency Episodic Migraine. July 22, 2022. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05003362
  25. ClinicalTrials.gov. Migraine Difficult to Treat: The Importance of Psychological Care in the Chronic Patient. December 22, 2022. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05658185
  26. ClinicalTrials.gov. How Pain Resilience Determines the Efficacy of Holistic Health Care of Patients with Migraine. August 9, 2022. Accessed from: https://clinicaltrials.gov/ct2/show/NCT04743492