Levetiracetam in Central Pain in Multiple Sclerosis(MS)

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: Multiple Sclerosis
• Intervention / Treatment: Drug: levetiracetam

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

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

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)	Weekly

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Søren H Sindrup, MD, Department of Neurology, Odense Unviersity Hospital

Study record dates

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: multiple sclerosis; levetiracetam; central pain
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: keppra3