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

Primary Purpose

Chronic Neuropathic Pain

Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
gabapentin
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neuropathic Pain focused on measuring gabapentin, neuropathic pain, driving, attention

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Utrecht

Outcomes

Primary Outcome Measures

driving test parameters

Secondary Outcome Measures

laboratory test parameters
Event Related Potentials

Full Information

First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
UMC Utrecht
Collaborators
Utrecht University
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1. Study Identification

Unique Protocol Identification Number
NCT00189072
Brief Title
Effects of Gabapentin in the Treatment of Neuropathic Pain on Driving Performance and Cognition
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Terminated
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
UMC Utrecht
Collaborators
Utrecht University

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neuropathic Pain
Keywords
gabapentin, neuropathic pain, driving, attention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gabapentin
Primary Outcome Measure Information:
Title
driving test parameters
Secondary Outcome Measure Information:
Title
laboratory test parameters
Title
Event Related Potentials

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmund Volkerts, PhD
Organizational Affiliation
Utrecht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utrecht
City
Utrecht
ZIP/Postal Code
3508 TB
Country
Netherlands

12. IPD Sharing Statement

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

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