Levetiracetam in Central Pain in Multiple Sclerosis(MS)

Phase 4

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT00423527
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-01
• Study Start: 2007-01
• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-16
• Study First Posted: 2007-01-18
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2009-12-17
• Last Update Posted: 2009-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Department of Neurology, Odense University Hospital; 🇩🇰 Odense C, Denmark