Effects of Gabapentin in the Treatment of Neuropathic Pain on Driving Performance and Cognition

September 12, 2005 updated by: UMC Utrecht

Effects of Pain and the Treatment of Pain With Gabapentin (900-3600 Mg) on Driving Ability, Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients

The aim of this study was to explore the effects of pain on the one hand and the effects of treatment of pain with gabapentin (900, 1200, 1800 or 2400 mg) on the other hand on actual driving performance and several laboratory tests in patients with neuropathic pain. It was hypothesized that gabapentin might influence performance after acute but not after subchronic administration.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Numerous studies demonstrate neuropsychological impairment in patients with chronic pain, particularely on measures assessing attentional capacity, processing speed and psychomotor speed. About 50% of the patients suffering from neuropathic pain are treated with anticonvulsants, as a treatment against serious pain complaints, and experience good pain relief. Gabapentin is one of the most prescribed anticonvulsants for the treatment of neuropathic pain. An important disadvantage of treatment with gabapentin could be the occurrence of side effects, such as somnolence and fatigue. These side effects can constitute a crucial problem for patients treated with gabapentin who must operate a motor vehicle or other dangerous machinery. However, pain affects cognition negatively, and possibly also driving. Therefore, another possibility is that treatment with gabapentin for these pain complaints can improve driving because the pain has less influence. Since driving is an activity of daily living that is important in maintaining independency in the community, such as access to employment and social activities, it is important to establish the effects of using gabapentin on these abilities. No studies have been conducted so far to investigate driving abilities of patients with neuropathic pain, treated with gabapentin.The aim of this study was to explore the effects of pain on the one hand and the effects of acute (Day 1) and subchronic (Day 15) treatment of pain with gabapentin (900, 1200, 1800 or 2400 mg) on the other hand on actual driving performance and several laboratory tests in patients with neuropathic pain. It was hypothesized that gabapentin might influence performance after acute but not after subchronic administration. This study is a two-period double-blind, placebo-controlled, cross-over randomised study.

Study Type

Interventional

Enrollment

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508 TB
        • University of Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age, responder to gabapentin,succesfully treated with gabapentin at least 4 weeks before start of study, minimal VAS pain intensity scores of 4 cm on a 10 cm scale, driving licence, driving experience, fluently speaking Dutch, normal vision, right-handed

Exclusion Criteria:

  • alcohol- or drug dependence, use of other psychotropic medication, use of illicit drugs, psychological or physical disorder other than pain or pain-related, excessive smoking and drinking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
driving test parameters

Secondary Outcome Measures

Outcome Measure
laboratory test parameters
Event Related Potentials

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

Utrecht University

Investigators

  • Principal Investigator: Edmund Volkerts, PhD, Utrecht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 16, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/327

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Neuropathic Pain

Clinical Trials on gabapentin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe