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

Astellas

Status and phase: Completed; Phase 3

Conditions: Restless Legs Syndrome

Treatments: Drug: ASP8825

Study type: Interventional

Funder types: Industry

Identifiers

NCT02658188

8825-CL-0005

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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182 participants in 1 patient group

ASP8825 group

Experimental group

Treatment:

Drug: ASP8825