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Title: Age Does Not Interfere With Ropinirole's Effectiveness in Restless Legs Syndrome: Presented at AAN

"Age Does Not Interfere With Ropinirole's Effectiveness in Restless Legs Syndrome: Presented at AAN"

By Jill Stein MIAMI, FL -- April 12, 2005 -- Although 2 different phenotypes are involved with restless legs syndrome (RLS) based on age-at-onset, they both have similar clinical responses to the dopamine agonist ropinirole. Richard Allen, PhD, research associate in neurology, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States, presented pooled data from 3 12-week efficacy trials here on April 12[^th at the American Academy of Neurology 57^th Annual Meeting.

Dr. Allen and colleagues conducted their analysis to compare responses to dopaminergic treatment for the 2 different RLS phenotypes -- early- and late-onset. The early-onset phenotype starts before the age of 45 years, is often slowly progressive, has a familial component, and may have a strong genetic component. Late-onset RLS usually shows rapid progression of symptoms, is not familial in nature, and may be influenced by environmental factors.

"Early- and late-onset RLS phenotypes may involve differing biological processes with a common final symptom expression that is equally responsive in this patient population to the dopamine agonist ropinirole," Dr. Allen noted. "This suggests a common final dopamine pathology despite differing etiologies."

The 3 trials enrolled patients who were from 18 to 80 years of age, had a primary diagnosis of RLS based on the International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria, a minimum of 15 nights of RLS symptoms during the prior month, and a total score of 15 on the International Restless Legs Scale (IRLS).

Patients were randomised to ropinirole or placebo once daily 1 to 3 hours before bedtime at an initial dose of 0.25 mg/day. The dose was titrated over 7 weeks until the optimal effect was reached (to a maximum of 4.0 mg/day).

Age-at-onset was similarly distributed in both treatment groups (a mean of 36.5 years in both).

Results show no evidence of an interaction between age-at-onset and response to treatment based on IRLS score (P =.9627) or Clinical Global Impression-Improvement (P =.3986).

After ropinirole treatment, the adjusted mean change from baseline in IRLS score at week 12 last observation carried forward (LOCF) was -11.4 for the 196 early-onset patients and -10.6 for the 107 late-onset patients.

There were also no significant differences in the final treatment dose of ropinirole between the 2 treatment groups.

The changes in the IRLS were similar for both phenotypes in the 299 placebo-treated patients.

Further analysis of the effects of ropinirole treatment in relation to age at onset of RLS is ongoing and results are expected shortly, Dr. Allen said.

The study was sponsored by GlaxoSmithKline Research and Development.

[Presentation title: Clinical Efficacy of Ropinirole for RLS Is Unaffected by Age-at-Onset Phenotype: Pooled Analysis of Three Clinical Trials. Abstract P01.045]

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