XenoPort releases positive data from XP13512 'restless leg' trial

By Elaine Rigoli

Tampa, Fla., March 29 - XenoPort, Inc. released data from the company's phase 2b clinical trial of XP13512 for the treatment of Restless Legs Syndrome (RLS) showing significant benefits to patients with RLS when dosed at 1,200 mg once per day for 14 days.

The trial was a multi-center, randomized, double-blind, placebo-controlled trial that enrolled 95 RLS patients, according to a news release.

Patients were randomized to one of three treatment groups: a placebo, 600 mg of XP13512 or 1,200 mg of XP13512, all dosed once per day at 5 p.m. with food. The primary endpoint of the clinical trial was improvement in the International Restless Legs Syndrome (IRLS) scale score.

Treatment with 1,200 mg of XP13512 was associated with a highly statistically significant improvement in the IRLS scale score compared with a placebo at the end of 14 days of treatment.

A statistically significant reduction in the IRLS scale score was also observed after one week of treatment, the release said.

Additional secondary endpoints of the clinical trial were the improvement in both Patient and Investigator Clinical Global Impression of Change (CGI) scales.

Treatment with 1,200 mg of XP13512 was associated with statistically significant improvements in both CGI scales compared to a placebo. Treatment with 1,200 mg of XP13512 was also associated with improvements compared with a placebo in a number of subjective measures of sleep, including overall quality of sleep, the number of awakenings per night due to RLS symptoms and the number of hours awake per night due to RLS symptoms.

Finally, treatment with 1,200 mg of XP13512, compared to a placebo, was associated with a statistically significant reduction in the severity of RLS symptoms in the evening (8 p.m. to midnight) as measured using a 24-hour RLS symptom diary on the final day of treatment.

Clinical effects measured by the above endpoints in patients treated with 600 mg of XP13512 were not statistically different from patients treated with a placebo, the release said.

XenoPort is a Santa Clara, Calif.-based biopharmaceutical company developing product candidates that use the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs.

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