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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

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