Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Long-term Study - Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.

Inclusion Criteria:

• Patients who diagnosed with RLS according to the diagnostic criteria established by the International RLS Study Group
• International Restless Legs Syndrome Scale (IRLS) score ≥15 presence of RLS symptoms on ≥15 days per month and ≥4 days per week preceding inclusion in this study

Exclusion Criteria:

• Patients using dopamine agonists or gabapentin within 1 week before or any anti-RLS treatment within 2 weeks before the start of the pretreatment observation period
• Patients with an estimated creatinine clearance <60 mL/min determined using the Cockcroft-Gault formula
• Pregnant or lactating women
• Individuals with serum ferritin <20 ng/mL were also excluded from the trial
• Individuals with movement disorders and/or abnormal neurological findings