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:
AbbVie M23-714 Menstrual migraine
This study’s primary objective is to evaluate the preventative treatment for people with Menstrual Migraines. The medication in this study is Ubrogepant, an orally disintegrating tablet developed by AbbVie Pharmaceutical company. Ubrogepant has been approved by regulatory authorities to treat specific medical conditions but is currently not approved for the treatment of Menstrual Migraines. The approved medication is named Ubrelvy and is approved to treat acute migraines with or without aura in adults. In this study the primary aim is to evaluate the effectiveness of the study medication in reducing the number of migraine days experienced. The study includes up to 13 visits over 84 weeks. With three phases of the trial including a 16 week screening phase, a 16 week treatment period where you have a 50% chance of receiving the study medication, and a 52 week open label extension period where the medication is guaranteed.
Lundbeck PROCEED LU20297A
In this study, the primary goal is to determine what doses of medication are recommended to help prevent migraines. The study medication in this trial is Lu AG09222, a subcutaneously injected monoclonal antibody that is currently not approved by the FDA. The study will take place over the course of 24 weeks and subjects will have a 67% chance of receiving the study drug. The study includes three phases including a screening period, treatment period, and follow up period.
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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
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.