Levetiracetam in Central Pain in Multiple Sclerosis(MS)

December 17, 2009 updated by: Odense University Hospital

Double-blind, Randomised,Placebo-controlled Trial of Levetiracetam in Central Pain in Multiple Sclerosis

Multiple sclerosis is often associated with pain. There is no standard treatment of this type of pain. Levetiracetam is a new anticonvulsant and it is the hypothesis that it could relieve central pain in multiple sclerosis. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3000 mg daily on pain in multiple sclerosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ms diagnosis verified
  • age > 18 years
  • central pain symptoms for more than 3 months
  • central pain diagnosis confirmed by neurological examination
  • adequate anticonceptive treatment for women with child bearing potential
  • informed consent
  • baseline pain of more than 4 on numeric rating scale

Exclusion Criteria:

  • other cause of pain
  • previous allergic reaction towards levetiracetam
  • known adverse drug reaction 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 of each period)
Time Frame: Weekly
Weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain rated on a 0 to 10 point numeric rating scale
Time Frame: Daily
Daily
Pain subtypes rated on the same scale.
Time Frame: Daily
Daily
Brush-evoked pain
Time Frame: Baseline and end of each treatment period
Baseline and end of each treatment period
Pin-prick-evoked pain
Time Frame: Daily
Daily
Cold-evoked pain
Time Frame: Daily
Daily
Health related quality of life (SF36)
Time Frame: Baseline and end of each treatment period
Baseline and end of each treatment period
Pain related sleep disturbance
Time Frame: Daily
Daily
Use of escape medication
Time Frame: Daily
Daily
Muscle spasms as measured on 2 different scales
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

  • Principal Investigator: Søren H Sindrup, MD, 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, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

January 16, 2007

First Submitted That Met QC Criteria

January 16, 2007

First Posted (Estimate)

January 18, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2009

Last Update Submitted That Met QC Criteria

December 17, 2009

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • keppra3

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 Multiple Sclerosis

Clinical Trials on levetiracetam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe