A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Inclusion Criteria

• •Subject has Restless Legs Syndrome (RLS), based on the International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic Criteria.
• •Subject has reported history of RLS symptoms for at least 15 days in the month prior to the first dosing; if on treatment, this frequency of symptoms was started before treatment.
• •Subject with International Restless Legs Syndrome Rating Scale (IRLS) score ≥ 15.
• •Subject has discontinued dopamine agonists, and/or gabapentin at least 1 week prior to the first dosing.
• •Subject has discontinued other treatments for RLS at least 2 weeks prior to the first dosing.
• •Female subject must either:
• •Be of non-childbearing potential:
• •Post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
• •documented surgically sterile
• •Or, if of childbearing potential:
• •Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
• •And have a negative urine pregnancy test at Screening
• •And, if heterosexually active, agree to consistently use two forms of highly effective birth control starting at Screening and throughout the study period and for 28 days after the final study drug administration.
• •* Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
• •* Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
• •* Subject agrees not to participate in another interventional study while on treatment.
• •* Subject with a Body Mass Index of ≥ 18.5 and \< 30.
• •* Subject with estimated creatinine clearance of ≥ 60 mL/min.