XenoPort And GlaxoSmithKline Report Positive Top-line Results Of Final Pivotal Trial Of XP13512/GSK1838262 For Restless Legs Syndrome
"We have now demonstrated in three Phase 3 trials that XP13512 treatment leads to a clear improvement in RLS symptoms. Based on data from the RLS clinical program, we believe that XP13512 could offer compelling benefits to patients with primary RLS," said Ronald W. Barrett, Ph.D., chief executive officer of XenoPort.
"This novel compound is the first non-dopaminergic agent to demonstrate efficacy in controlled clinical trials for the treatment of primary RLS and may offer patients a new treatment option," said Atul Pande, M.D., senior vice president, GlaxoSmithKline Neurosciences Medicines Development Center. "With the completion of this third Phase 3 clinical trial, we look forward to filing the NDA for primary RLS in the third quarter of 2008."
This clinical trial (XP053) was a 12-week, double-blind, placebo-controlled Phase 3 clinical trial that enrolled 325 patients who were diagnosed with moderate-to-severe primary RLS. Patients were treated with 1200 mg or 600 mg of XP13512 or placebo, given once per day. The pre-specified primary efficacy analysis of the study was the comparison of the 1200 mg XP13512 and placebo treatment groups. The co-primary endpoints for the clinical trial were the change from baseline for the International Restless Legs Syndrome (IRLS) rating scale score at end of treatment and the percentage of patients showing significant improvement on the Investigator Clinical Global Impression of Improvement (CGI-I) scale at end of treatment.
Results from the pre-specified analysis indicate that treatment with 1200 mg of XP13512 was associated with statistically significant improvements in the co-primary endpoints compared to placebo. Improvements in the IRLS scale score were significantly greater for 1200 mg XP13512 than for placebo (unadjusted mean values: -13.0 for 1200 mg XP13512; -9.8 for placebo; p=0.0015). At the end of treatment, significantly more patients treated with 1200 mg of XP13512 were reported as "much improved" or "very much improved" on the CGI-I scale compared to those treated with placebo (78% for 1200 mg XP13512; 45% for placebo; p< 0.0001).
Treatment with 600 mg of XP13512 was also associated with statistically significant improvements in the IRLS and CGI-I endpoints compared to placebo. The unadjusted mean reduction in the IRLS scale score was -13.8 for 600 mg XP13512 patients (p
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