Levetiracetam in Central Pain in MS
Information source: Odense University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Central Pain in Multiple Sclerosis
Intervention: levetiracetam (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Odense University Hospital Official(s) and/or principal investigator(s):
Søren H Sindrup, MD, Principal Investigator, Affiliation: Department of Neurology, Odense Unviersity Hospital
Overall contact:
Søren H Sindrup, MD, Phone: +45 65412471, Email: soeren.sindrup@ouh.fyns-amt.dk
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.
Clinical Details
Official title: Double-Blind, Randomised,Placebo-Controlled Trial of Levetiracetam in Central Pain in Multiple Sclerosis
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week of each period)
Secondary outcome: Pain rated on a 0 to 10 point numeric rating scalePain subtypes rated on the same scale. Brush-evoked pain Pin-prick-evoked pain Cold-evoked pain Health related quality of life (SF36) Pain related sleep disturbance Use of escape medication Muscle spasms as measured on 2 different scales
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Søren H Sindrup, MD, Phone: +45 65412471, Email: soeren.sindrup@ouh.fyns-amt.dk
Department of Neurology, Odense University Hospital, Odense C DK-5000, Denmark
Additional Information
Starting date: January 2007
Ending date: January 2009
Last updated: January 16, 2007
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