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Levetiracetam in Central Pain in Multiple Sclerosis(MS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00423527
First Posted: January 18, 2007
Last Update Posted: December 18, 2009
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.
Information provided by:
Odense University Hospital
  Purpose
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 Intervention Phase
Multiple Sclerosis Drug: levetiracetam Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

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

Estimated Enrollment: 30
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: levetiracetam
    Levetiracetam tablets 500 mg, total daily dose 3000 mg
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00423527


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

Responsible Party: Professor Søren H. Sindrup, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00423527     History of Changes
Other Study ID Numbers: keppra3
First Submitted: January 16, 2007
First Posted: January 18, 2007
Last Update Posted: December 18, 2009
Last Verified: January 2007

Keywords provided by Odense University Hospital:
multiple sclerosis
central pain
levetiracetam

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs


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