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

This study has been completed.

First Received on July 28, 2011.  
Last Updated on November 3, 2011  
History of Changes
This Clinical Trial Sponsored By: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01411124
 

Purpose for Clinical Trial

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.

Condition Study Intervention Clinical Trial Phase
Restless Legs Syndrome
Restless Legs Syndrome (RLS)
Drug: gabapentin enacarbill
Drug: diphenhydramine
Drug: placebo
Phase 1

Study Type: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Study Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Active- and Placebo-Controlled, Crossover Study Assessing the Effect of 600 mg Gabapentin Enacarbil on Simulated Driving in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics:
Restless Legs
Drug Information available for:
Promethazine hydrochloride
Diphenhydramine
Promethazine
Diphenhydramine hydrochloride
Gabapentin
Diphenhydramine citrate
Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures For Clinical Trial:

  • Lane performance Variability [ Time Frame: From Day-1 baseline to end of treatment. Participants will be followed for the duration of the clinic visit an average of 3 weeks. ] [ Designated as safety issue: No ]
    change from baseline in lane posistion variability

Secondary Outcome Measures For Clinical Trial:

  • Change in Speed Variability [ Time Frame: from baseline to end of treatment Participants will be followed for the duration of the clinic visit an average of 3 weeks ] [ Designated as safety issue: No ]
    Change from baseline in speed variability

  • number of simulated crashes [ Time Frame: on Days 5 and 6. The subjects will be followed for the duration of the clinic visit an average of 3 week ] [ Designated as safety issue: No ]
    number of simulated crashes

  • Visual Analog Scale [ Time Frame: Baseline to end of treatment. The subjects will be followed for the duration of the clinic visit an average of 3 weeks ] [ Designated as safety issue: No ]
    Pre driving alterness measured by the Visual analog scale

  • Visual analog scale on post driving alertness [ Time Frame: baseline to days 5 and 6. The subjects will be followed for the duration of the clinic visit an average of 3 weeks ] [ Designated as safety issue: No ]
    Post driving alterness measured by visual alterness scale

  • Visual Analog scale of the difference between pre and post driving alertness [ Time Frame: baseline to days 5 and 6. The subjects will be followed for the duration of the clinic visit an average of 3 weeks ] [ Designated as safety issue: No ]
    difference between pre and post driving alertness

  • Incidents of Adverse events [ Time Frame: baseline to end of study. The subjects will be followed for the duration of the clinic visit an average of 3 weeks ] [ Designated as safety issue: Yes ]
    safety and tolerability from baseline to end of study

  • Plasma concentrations of gabapentin [ Time Frame: Day 5. The subjects will be followed for the duration of the clinic visit an average of 3 weeks ] [ Designated as safety issue: No ]
    Plasma concentration of gabapentin on completion of driving test

Enrollment: 36
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Gabapentin Enacarbil

600 mg of Gabapentin Enacarbil
Drug: gabapentin enacarbill

600 mg investigational compound

Drug: placebo

placebo
Active Comparator: diphenhydramine

50 mg
Drug: diphenhydramine

50 mg active comparator

Drug: placebo

placebo
Placebo Comparator: placebo

placebo to match
Drug: placebo

placebo

Detailed Description:

proportional systemic gabapentin exposure over a wide dose range. 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. Subjects will receive each of 3 treatments in a randomized order: GEn 600 mg, placebo and placebo/diphenhydramine 50 mg. Each treatment period will consist of 6 days, with subjects being dosed at approximately 5 pm on each dosing day. The placebo /diphenhydramine treatment will consist of placebo on Days 1-4 and 6 and 50 mg diphenhydramine on Day 5. Placebo will be administered on Day 6 in all treatment periods to ensure washout of drug prior to the start of the next treatment period. Simulated driving performance will be assessed at baseline (prior to randomization) and on Day 5 in the evening (7-9 pm) and on Day 6 between7-9 am and between 11am-1pm for each treatment period.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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