NCT01981941

Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment

Post-marketing Clinical Study of Gabapentin Enacarbil -Non-blinded Study in Restless Legs Syndrome (RLS) Patients With Moderate Renal Impairment-

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to severe primary RLS patients with moderate renal impairment and to confirm dosage and administration in such population.

Detailed description

This study is a multicenter, non-blinded, non-comparative study. Patients who meet the eligible criteria will undergo one week observation period followed by four week treatment period. In treatment period, patients will receive gabapentin enacarbil orally one daily after dinner. After the four-week treatment period with gabapentin enacarbil, a one-week post-observation period will be undertaken.

Conditions

• Restless Legs Syndrome (RLS)

Interventions

Type	Name	Description
DRUG	Gabapentin enacarbil	Oral

Timeline

• Start date: 2013-11-05
• Primary completion: 2015-05-13
• Completion: 2015-05-13
• First posted: 2013-11-13
• Last updated: 2024-11-08

Locations

5 sites across 1 country: Japan