GlaxoSmithKline study shows Requip improves symptoms on Restless Legs Syndrome

By E. Janene Geiss

Philadelphia, Jan. 3 - GlaxoSmithKline said Tuesday that results from clinical trials show Requip (ropinirole Hcl) tablets significantly improve symptoms of Restless Legs Syndrome.

Results of the study, the largest in the United States for Restless Legs Syndrome treatments, support previous studies with Requip, the first and only FDA-approved treatment for moderate-to-severe primary Restless Legs Syndrome, according to a company news release.

The syndrome is a chronic and disruptive neurological condition that encompasses a range of severity that includes mild, moderate and severe symptoms. It affects about one in 10 adults in the United States, officials said.

"The consistency of positive data across several key clinical trials, including these latest results from the largest study of the treatment of [Restless Legs Syndrome], further supports Requip as an effective treatment for relieving the uncomfortable symptoms of [Restless Legs Syndrome]," Richard K. Bogan, assistant clinical professor of medicine, USC School of Medicine in Columbia, S.C., and lead author of the study, said in the release.

The 12-week study included 47 centers across the United States and was a double-blind, randomized, placebo-controlled study of 380 adult patients (ages 18-79) with primary Restless Legs Syndrome symptoms 15 or more times in the last month, officials said.

In the study, researchers observed statistically significant improvements in symptoms in favor of Requip versus placebo according to two validated, subjective questionnaires called the International Restless Legs Syndrome Rating Scale and the Clinical Global Impression - Improvement (CGI-I) Scale.

The study met the primary endpoint, showing that Requip decreased symptom severity according to the IRLS total score when measured at week 12 compared to placebo.

Using the same scale, patients taking Requip reported significant improvement in symptoms after two nights of treatment versus placebo, officials said.

The study met secondary endpoints, with researchers observing similar improvements in symptoms after two nights and at weeks one and 12 using the CGI-I scale.

The data was published in the January issue of the Mayo Clinic Proceedings, officials said.

GlaxoSmithKline is a Research Triangle Park, N.C., pharmaceutical and health care company.

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