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Levetiracetam in Central Pain in Multiple Sclerosis(MS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
levetiracetam
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, central pain, levetiracetam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, Odense University Hospital

Outcomes

Primary Outcome Measures

Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week of each period)

Secondary Outcome Measures

Pain rated on a 0 to 10 point numeric rating scale
Pain 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

Full Information

First Posted
January 16, 2007
Last Updated
December 17, 2009
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00423527
Brief Title
Levetiracetam in Central Pain in Multiple Sclerosis(MS)
Official Title
Double-blind, Randomised,Placebo-controlled Trial of Levetiracetam in Central Pain in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Odense University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, central pain, levetiracetam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
levetiracetam
Intervention Description
Levetiracetam tablets 500 mg, total daily dose 3000 mg
Primary Outcome Measure Information:
Title
Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week of each period)
Time Frame
Weekly
Secondary Outcome Measure Information:
Title
Pain rated on a 0 to 10 point numeric rating scale
Time Frame
Daily
Title
Pain subtypes rated on the same scale.
Time Frame
Daily
Title
Brush-evoked pain
Time Frame
Baseline and end of each treatment period
Title
Pin-prick-evoked pain
Time Frame
Daily
Title
Cold-evoked pain
Time Frame
Daily
Title
Health related quality of life (SF36)
Time Frame
Baseline and end of each treatment period
Title
Pain related sleep disturbance
Time Frame
Daily
Title
Use of escape medication
Time Frame
Daily
Title
Muscle spasms as measured on 2 different scales
Time Frame
Baseline and end of each treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren H Sindrup, MD
Organizational Affiliation
Department of Neurology, Odense Unviersity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Odense University Hospital
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark

12. IPD Sharing Statement

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Levetiracetam in Central Pain in Multiple Sclerosis(MS)

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