A double blind, randomized, placebo-controlled, cross-over study to evaluate the effects of Levetiracetam on membrane excitability properties of afferent myelinated and unmyelinated fibers and change in neuropathic pain in patients with painful traumatic nerve injury.

• Conditions: europathic pain due to a traumatic nerve lesion

• Registration Number: EUCTR2004-002114-11-ES
• Lead Sponsor: Infociencia Clinical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients, male or female, aged between 18 and 70 years.
Patients with presence of neuropathic pain due to a traumatic nerve lesion.
Patients must have an electrophysiological evaluation confirming the diagnosis of traumatic in-continuity nerve lesion and discarding other possible diagnosis.
Patients with minimum score of 4 on the average daily pain score in Daily Record Cards during one week.
Patients must give their written informed consent to participate in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with a history, clinically significant laboratory abnormality, or other evidence of severe medical or neurological disease or malignancy which may impair their reliable participation in the study, or confound the interpretation of the data, or necessitate the use of medication not allowed by this protocol.
Patients with clinically significant psychiatric illnesses that would impair their reliable participation in this trial.
Patients who have other pain that may confound the assessment of the neuropathic pain.
Patients with skin lesions in the area affected by the neuropathy that could alter sensation (signs of neurogenic inflammation will not be exclusion criteria).
Patients with clinically significant EKG abnormalities.
Patients with a history of renal insufficiency documented (creatinine clearance < 30 mL/min).
Patients who have a history of alcohol and/or drug abuse.
Patients known to be hypersensitive to levetiracetam or their metabolites.
Patients who have received an experimental treatment within the past month.
Potentially fertile females who do not use hormonal contraception, or do not follow any other acceptable medical way of contraception, or pregnant or breast-feeding women.
Patients who are suspected to have poor compliance with the study.
Patients taking other antiepileptic drugs. Other medication for neuropathic pain (e.g., tricyclic antidepressants) will be permitted during the study if the dose remains stable.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effects of Levetiracetam on neuropathic pain level in patients with traumatic nerve injury;Secondary Objective: To assess the effects of Levetiracetam on membrane excitability properties of human A-beta and C fibers in patients with painful traumatic nerve injury<br><br>To assess safety and tolerability of Levetiracetam in the study group;Primary end point(s): Change from baseline in average daily pain score.