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Phenytoin and Driving Safety: A Randomized, Controlled Cross-Over Study

NCT00581893 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-07-01

Study results available
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Summary

Automobile driving is a crucial aspect of everyday life, yet vehicular crashes represent a serious public health problem. Patients with epilepsy are at elevated risk for automobile crashes, causing great personal suffering and financial costs to society. Most collisions involving epileptic drivers are not seizure related but may instead result from cognitive effects upon driving performance of epilepsy and antiepileptic drugs (AEDs). Several million American drivers take AEDs for treatment of medical conditions besides epilepsy and may also be at risk for cognitive impairments that can reduce driving performance. Empirical evidence of the effects of AEDs on driving performance would enable development of driving guidelines that could lower the risk of injurious motor vehicle collisions; however, this evidence is currently lacking. The broad goal of our project is to determine the specific effects of the most commonly utilized AED, phenytoin, by assessing driving performance and cognitive abilities in neurologically normal volunteers taking phenytoin in a randomized, double-blind, placebo-controlled, crossover study. Our proposed experiments will assess: (1) cognitive functions using standardized neuropsychological tests (of attention, perception, memory, and executive functions), (2) driving performance during phenytoin and placebo administration, and (3) the effects of phenytoin-related cognitive performance upon driving performance. To measure driving performance, we will use a state-of-the-art fixed-base interactive driving simulator that allows us to observe driver errors in an environment that is challenging yet safe for the driver and tester, under conditions of optimal stimulus and response control. The results of this study of 30 drivers treated with phenytoin and placebo will increase the understanding of the role of AED-related cognitive impairment on driving safety errors. A better understanding of the impact of AEDs upon driving performance is necessary to rationally develop interventions that could help prevent crashes by drivers treated with AEDs.

Conditions

  • Cognitive Measures
  • Driving Simulator Performance

Interventions

DRUG

Phenytoin

Phenytoin will be dosed to a target dose of 5 mg/kg qhs for one month

DRUG

Placebo oral capsule

Placebo

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Erik K St. Louis, M.D. · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

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 NCT00581893 on ClinicalTrials.gov