Migraine is a chronic medical condition affecting an estimated 38 million people in the United States. Throbbing, often one-sided moderate-to-severe head pain, accompanied by light and sound sensitivity and nausea/vomiting are the most common symptoms. Some migraine sufferers experience dizziness, visual symptoms, numbness or weakness on one side of the body, slowed thinking or trouble speaking.
Migraine predominantly effects young and middle-aged woman (that is, during their prime work and child-rearing years), though it can strike men and children as well. When untreated, the World Health Organization lists migraine as among the top ten most disabling medical conditions.
Our migraine research program aims to find better acute and preventive treatments for adults and children who suffer from migraine. Our current and upcoming studies include:
BHV311 + 312
This study is designed for the acute treatment of migraines in adolescents aged 12-17 years old (ages 6-11 coming soon!) who experience around 1-8 migraine days a month. The medication used in this study, Rimegepant, is an orally disintegrating tablet made by Pfizer and approved by the FDA for the treatment of migraines in adults. The aim of this study is for it to become FDA approved for our pediatric migraine-sufferers as well. In this study, participants will treat up to 2 migraine attacks with the study drug and will either receive placebo or the active study medication. The initial study can last approximately 19 weeks. If eligible, participants will be able to take part in the open-label extension study where they will be able to treat their migraines with guaranteed Rimegepant for up to a year.
Learn more (initial study): https://www.clinicaltrials.gov/study/NCT04649242
Learn more (extension study): https://clinicaltrials.gov/study/NCT04743141
AXS-07-304
This is a short study for individuals who experience between 2-8 migraines per month and who haven’t gotten relief from a class of medication called oral CGRP inhibitors, which are drugs like Nurtec and Ubrelvy. The medication used in this study is called AXS-07, which is a combination pill of meloxicam and rizatriptan made by Axsome. There is no placebo during this study; you will be treated with the study medication for acute migraines over the course of 8 weeks or treatment for 4 migraine attacks, whichever comes first.
Learn more: https://classic.clinicaltrials.gov/ct2/show/NCT05550207
BHV406
This study is designed for the acute treatment of migraines in individuals who experience 4-14 migraine days a month who haven’t had success with a class of medications called triptans. Examples of triptan medications are Axert, Relpax, Frova, Amerge, Maxalt, Imitrex, Zomig, etc. The medication used in this study, Rimegepant, is made by Pfizer and is already FDA approved for the treatment of migraines in adults. In this study, participants will treat one migraine attack with the study drug, which will either be placebo or the active medication. If eligible, participants will be able to treat their migraines with open-label medication for the rest of the study (about 12 weeks).
Learn more: https://classic.clinicaltrials.gov/ct2/show/NCT05509400
BHV407
This study is designed for the prevention of migraines in individuals who experience 4-14 migraine days a month who haven’t had success with oral migraine preventive medications. This includes medications like topiramate, amitriptyline, gabapentin, propranolol, and more. The medication used in this study, Rimegepant, is made by Pfizer and is already FDA approved for the prevention of migraines in adults. If eligible, participants will take one dose of study drug every other calendar day for migraine prevention. The first 12 weeks of the study may be placebo or active medication, while the second 12 weeks of the study will be guaranteed active medication.
Learn more: https://clinicaltrials.gov/study/NCT05518123
C-BEOND & E-BEOND
This study is designed for the prevention of migraines in individuals who experience episodic migraine (less than 15 headache days a month with 6 or more of those days being a migraine) or chronic migraine (15 or more headache days a month with 8 or more of those days being a migraine). The study medication, called Dysport, is made by the company Ipsen and is administered as injections to different muscles of the head and neck where migraines manifest once every 3 months. Dysport is a type of medication that works by stopping the release of pain chemicals associated with migraines to reduce the amount of headache days experienced each month. The study lasts about 48 weeks, and the first two treatments may be placebo or active medication, while the second two treatments will be guaranteed active medication.
Learn more (chronic): https://classic.clinicaltrials.gov/ct2/show/NCT06047444
Learn more (episodic): https://classic.clinicaltrials.gov/ct2/show/NCT06047457
All studies at NEICR are available at no cost to you, and there may be compensation for time and travel. Participation is completely voluntary, and you may withdraw at any time. To find out more about any of our studies, give us a call at 203-914-1903 or fill out the form below.