Study Evaluates Treatment For Migraines

Armen Hareyan's picture

Approximately 28 million Americans suffer from chronic migraines. These very severe, throbbing headaches can prohibit someone from enjoying a trip to the park on a sunny day and sentence them to a dark room for comfort.

In an effort to set them free, neurologists at The Ohio State University Medical Center are participating in a multi-center clinical trial, evaluating the safety and effectiveness of an experimental drug used for the treatment of recurrent migraine headaches in adults.

This migraine therapy was developed essentially to help patients cope with these powerful, chronic headaches. People suffering from these migraines often describe "seeing" showers of shooting stars, zigzagging lines and flashing lights, and experiencing loss of vision, weakness, tingling or confusion. What follows these initial symptoms is seemingly infinite throbbing head pain, nausea and vomiting.

"Approximately 17 percent of migraine sufferers are treating their headaches with medications which have sedative effects," says Dr. Yousef Mohammad, a neurologist at the Ohio State's Medical Center.


The randomized outpatient clinical trial will evaluate the safety and effectiveness of an investigational drug in comparison to commonly prescribed barbiturates for the treatment of acute migraines in adults. As a crossover study, all participants enrolled in the study will receive the experimental medication at some point.

The investigational drug is a combination therapy, in tablet form, that combines sumatriptan and a nonsteroidal anti-inflammatory drug pain reliever for the treatment of migraine symptoms. Over the course of 19 weeks, study participants will be asked to treat three of their migraine attacks with either the experimental therapy, medications containing butalbital, which are similar to what they were previously taking, or a placebo. Participants are not told whether the tablet is medication or the placebo.

"There has been no clinical research to show that potentially addictive treatments are effective in treating migraines," says Mohammad, who is also principal investigator of the study at Ohio State.

Almost all migraine drugs have some side effects, including nausea, chest discomfort, dizziness, flushing, sleepiness and other gastric symptoms. Moreover, patients are prone to addiction from narcotics, or developing analgesic rebound headaches from frequent use of over- the-counter analgesics.

According to Mohammad, some research even states that commonly prescribed barbiturates may increase the frequency of migraine headaches if used too often.

"It is for this reason that we, as medical researchers, are working to develop new medications that are both safe and effective for migraine sufferers," Mohammad said.