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NCT00581893 · ClinicalTrials.gov registry record · Phase 4
Phenytoin and Driving Safety: A Randomized, Controlled Cross-Over Study
A Phase 4 study of Cognitive Measures and Driving Simulator Performance, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00581893 is a Phase 4 study of Cognitive Measures and Driving Simulator Performance that has completed, run by University of Iowa. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00581893, a Phase 4 study of Cognitive Measures and Driving Simulator Performance, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- DRUG Placebo oral capsule
- DRUG Phenytoin
Study Locations (1)
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00581893
The ClinicalTrials.gov registry entry for NCT00581893 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cognitive Measures appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT00581893 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT00581893 about?
NCT00581893 is a clinical study titled "Phenytoin and Driving Safety: A Randomized, Controlled Cross-Over Study". 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 a...
What is the current status of trial NCT00581893?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2005-08. Estimated completion is 2008-12.
What conditions does trial NCT00581893 study?
This clinical trial studies the following conditions: Cognitive Measures, Driving Simulator Performance.
What interventions are being tested in trial NCT00581893?
The interventions under investigation include: Placebo oral capsule (DRUG), Phenytoin (DRUG).
Who is sponsoring clinical trial NCT00581893?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00581893 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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