(RxWiki News) Discomfort, difficulty sleeping and the urge to move are all symptoms of restless legs syndrome that interfere with normal life when they become severe. A new study looked at a drug that might relieve those symptoms.
Researchers tested a drug currently used for Parkinson's disease on people who suffered from severe restless legs syndrome (RLS). During the first phase of the trial, they compared a treatment group to fake medicine. During the longer second phase, they gave the drug to each of the participants.
They found that the drug did relieve symptoms of RLS, particularly during the longer phase of the trial. Additionally, participants' sleep habits and quality of life improved over the course of the trial.
The researchers suggested that the drug could work because it promotes the production of dopamine in the brain.
"Talk to your doctor about treatment options for RLS."
Luisi Giorgi, MD, of Eisai, Inc, an independent pharmaceutical research company led the study in order to see if a certain drug improved symptoms of restless legs syndrome.
Restless legs syndrome is a neurological condition in which the patient feels the urge to move their legs in response to uncomfortable sensations. People with RLS sometimes experience only minor symptoms, but for others, the disorder can cause major disruptions to sleep and quality of life.
Many patients with restless legs syndrome can be treated without prescription drugs. Moving the affected limbs, dietary changes and certain supplements can be used to relieve symptoms for people with mild to moderate restless legs syndrome.
Drugs that enhance the brain's dopamine production have been used to treat severe restless legs syndrome.
This study tested ropinirole, a drug typically prescribed to treat Parkinson's disease, in 404 patients who experienced severe symptoms of RLS. Ropinirole is a dopamine-receptor agonist which means that it acts on the same receptors in your brain as a chemical called dopamine. In effect, it acts like a substitute for dopamine and this helps to ease symptoms of Parkinson's. The most common side effects for ropinirole are nausea, vomiting and drowsiness.
To determine the participants' baseline severity of symptoms, as well as their symptoms throughout the trial, the researchers used the International Restless Legs Scale, or IRLS. The scale has patients rate their discomfort, need to move, relief after movement, sleep disturbance, mood disturbance and other symptoms on a scale of 0-40. The highest score indicates the most discomfort. All patients in this study had scores greater than 24 at the start of the study.
People with severe restless legs syndrome would experience extreme discomfort in their legs frequently, and the disease would significantly affect their sleep and daily life. Additionally, they would experience symptoms for several hours a day almost every day.
The trial involved a 26-week phase in which participants received either ropinirole or a placebo. Clinicians would follow up with participants every four weeks.
After 12 weeks, the researchers would measure the severity of the participants' symptoms. They also took note of any adverse events or side effects.
After the 26 week phase was over, all of the participants received ropinirole for 40 weeks. Clinicians followed up with participants periodically throughout this phase.
During the first phase, the participants in the treatment group received a daily dose of ropinirole for a median duration of 175 days.
Before the participants began taking the medication, the average IRLS score was similar between those in the treatment group and those in the placebo group.
After 12 weeks of treatment, those in the treatment group reported an average of 2.1 point reduction of their IRLS score, which indicates an improvement in symptoms. By the last week of treatment, the participants receiving ropinirole reported a 2.5 point decrease in the IRLS score.
During the first phase, 60 percent of participants in the placebo group reported an adverse event compared with 74 percent in the treatment group. The most common adverse events were nausea, vomiting and diarrhea.
The researchers concluded that patients with severe restless legs syndrome who took ropinirole experienced significant benefits in terms of their RLS severity, general well-being, sleep habits and quality of life when compared to the patients who took a placebo.
The article was published in Clinical Therapeutics in September.
The research was funded by GlaxoSmithKline. All of the employees were employed by the company at the time the manuscript was submitted.