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

Restless Legs Syndrome (RLS) Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01981941
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 4
Start date November 5, 2013
Completion date May 13, 2015
View Details
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