drugset / Trial / NCT02633657

A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS

NCT02633657

Phase 1 Withdrawn XenoPort, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe Primary Restless Legs Syndrome (RLS).

Timeline

Start
2016-01
Primary completion
2017-07-19
Completion
2017-07-19

Drugs

EvaluationDrugModalityDoseRoute
Subject gabapentin enacarbil Small molecule 300 mg Oral