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Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects

NCT01411124 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-07-16

No results posted yet for this study

Summary

This is a double-blind, placebo-and active-controlled 3-period crossover study designed to assess the effect of GEn 600 mg on simulated driving performance in healthy volunteers.

Conditions

  • Restless Legs Syndrome (RLS)

Interventions

DRUG

gabapentin enacarbil

600 mg investigational compound

DRUG

diphenhydramine

50 mg active comparator

DRUG

placebo

placebo

Sponsors & Collaborators

  • XenoPort, Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01411124 on ClinicalTrials.gov