Levetiracetam in Central Pain in Multiple Sclerosis(MS)

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00423527
• Other study ID #: keppra3
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2007
• Last updated: December 17, 2009
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: January 2007
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• levetiracetam
Levetiracetam tablets 500 mg, total daily dose 3000 mg

Locations

Country	Name	City	State
Denmark	Department of Neurology, Odense University Hospital	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week of each period)		Weekly	No
Secondary	Pain rated on a 0 to 10 point numeric rating scale		Daily	No
Secondary	Pain subtypes rated on the same scale.		Daily	No
Secondary	Brush-evoked pain		Baseline and end of each treatment period	No
Secondary	Pin-prick-evoked pain		Daily	No
Secondary	Cold-evoked pain		Daily	No
Secondary	Health related quality of life (SF36)		Baseline and end of each treatment period	No
Secondary	Pain related sleep disturbance		Daily	No
Secondary	Use of escape medication		Daily	No
Secondary	Muscle spasms as measured on 2 different scales		Baseline and end of each treatment period	No