A University of Cincinnati (UC) clinician-researcher is the lead investigator of a phase-3 global clinical program that will evaluate an investigational medication for the treatment of pain associated with fibromyalgia.
Lesley Arnold, MD, a professor in the Department of Psychiatry and Behavioral Neuroscience, UC Health psychiatrist and director of the Women’s Health Research Program, is leading the ALDAY program, a large randomized, double-blind, placebo- and active-controlled study of mirogabalin (DS-5565). The drug is manufactured by Daiichi Sankyo Company, Limited, a global pharmaceutical company.
In addition to fibromyalgia, mirogabalin is currently being studied for the treatment of diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN). It is preferentially selective in how it binds to a protein that may help to regulate how the brain processes pain signals.
"Pain associated with the neurologic conditions of diabetic peripheral neuropathic pain, postherpetic neuralgia and fibromyalgia can be debilitating,” Arnold says. "New treatment options are needed to help people living with these neurologic conditions relieve and manage their chronic pain and hopefully improve their function and quality of life.”
In addition to pain, fibromyalgia is characterized by other symptoms including fatigue, sleep disturbance and cognitive symptoms such as forgetfulness or decreased concentration. It has a prevalence of about 2 to 3 percent of the U.S. population, with a higher prevalence in women than in men.
According to the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMSD), the causes of fibromyalgia are unknown, but there are probably a number of factors involved including a physically or emotionally stressful or traumatic event, repetitive injuries, illness or spontaneous occurrence. Many researchers are examining other causes, the NIAMSD says, including problems with how the central nervous system processes pain.
Phase-3 clinical trials are designed to test the safety and efficacy of a drug or device for possible approval by the Food and Drug Administration. The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow it to be used safely.
The ALDAY trial includes three randomized, double-blind, placebo- and active-controlled studies and an open label study that will be carried out over the next three years.
Approximately 4,000 patients with pain associated with fibromyalgia will be enrolled at approximately 800 clinical centers—including UC—at more than 40 countries.
For information about research studies of fibromyalgia at UC, call 513-558-6612.