Levetiracetam for Painful Polyneuropathy

December 17, 2009 updated by: Odense University Hospital

Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy

Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy

Study Overview

Status

Completed

Conditions

Painful Polyneuropathy

Intervention / Treatment

Drug: levetiracetam

Study Type

Interventional

Enrollment (Anticipated)

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

Denmark
- - Odense C, Denmark, DK-5000
    - Department of Neurology, Odense University Hospital

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

age 20 to 0 years
painful symptoms of polyneuropathy for at least 6 months
confirmed diagnosis of polyneuropathy
baseline pain score of 4 or more (0 to 10 point scale)
pain at least 4 days a week
adequate anticonceptive treatment for women with childbearing potential
informed consent

Exclusion Criteria:

other cause of pain
previous allergic reactions towards levetiracetam
known adverse drug reactions on levetiracetam
pregnancy
severe disease
inability to follow study protocol
treatment with antidepressants, other anticonvulsants or opioids

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: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period) Time Frame: Daily	Daily

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain related sleep disturbance Time Frame: Daily	Daily
Use of escape medication Time Frame: Daily	Daily
Pain rated on 0 to 10 point numeric rating scales Time Frame: Daily	Daily
Pain subtypes rated on 0 to 10 point numeric rating scales Time Frame: Daily	Daily
Bruch-evoked pain Time Frame: Baseline and end of each treament period	Baseline and end of each treament period
Pin-prick evoked pain Time Frame: Baseline and end of each treatment period	Baseline and end of each treatment period
Cold evoked pain Time Frame: Baseline and end of each treatment period	Baseline and end of each treatment period
Health related quality of life(SF-36) Time Frame: Baseline and end of each treatment period	Baseline and end of each treatment period

Collaborators and Investigators

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

Sponsor

Odense University Hospital

Investigators

Study Chair: Søren H Sindrup, Professor, Department of Neurology, Odense Unviersity Hospital

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

January 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

February 1, 2006

First Submitted That Met QC Criteria