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Levetiracetam in Central Pain in Multiple Sclerosis(MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00423527
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : December 18, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: levetiracetam Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomised,Placebo-controlled Trial of Levetiracetam in Central Pain in Multiple Sclerosis
Study Start Date : January 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 Measures :
  1. Pain rated on a 0 to 10 point numeric rating scale [ Time Frame: Daily ]
  2. Pain subtypes rated on the same scale. [ Time Frame: Daily ]
  3. Brush-evoked pain [ Time Frame: Baseline and end of each treatment period ]
  4. Pin-prick-evoked pain [ Time Frame: Daily ]
  5. Cold-evoked pain [ Time Frame: Daily ]
  6. Health related quality of life (SF36) [ Time Frame: Baseline and end of each treatment period ]
  7. Pain related sleep disturbance [ Time Frame: Daily ]
  8. Use of escape medication [ Time Frame: Daily ]
  9. Muscle spasms as measured on 2 different scales [ Time Frame: Baseline and end of each treatment period ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00423527

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Department of Neurology, Odense University Hospital
Odense C, Denmark, DK-5000
Sponsors and Collaborators
Odense University Hospital
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Principal Investigator: Søren H Sindrup, MD Department of Neurology, Odense Unviersity Hospital

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Responsible Party: Professor Søren H. Sindrup, Odense University Hospital Identifier: NCT00423527    
Other Study ID Numbers: keppra3
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: December 18, 2009
Last Verified: January 2007
Keywords provided by Odense University Hospital:
multiple sclerosis
central pain
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Nootropic Agents