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

NCT01981941 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-11-08

No results posted yet for this study

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.

Conditions

  • Restless Legs Syndrome (RLS)

Interventions

DRUG

Gabapentin enacarbil

Oral

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-05
Primary Completion
2015-05-13
Completion
2015-05-13

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01981941 on ClinicalTrials.gov