Levetiracetam in Central Pain in Multiple Sclerosis(MS)

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00423527
First received: January 16, 2007
Last updated: December 17, 2009
Last verified: January 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain rated on a 0 to 10 point numeric rating scale [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Pain subtypes rated on the same scale. [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Brush-evoked pain [ Time Frame: Baseline and end of each treatment period ] [ Designated as safety issue: No ]
  • Pin-prick-evoked pain [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Cold-evoked pain [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Health related quality of life (SF36) [ Time Frame: Baseline and end of each treatment period ] [ Designated as safety issue: No ]
  • Pain related sleep disturbance [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Use of escape medication [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Muscle spasms as measured on 2 different scales [ Time Frame: Baseline and end of each treatment period ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Professor Søren H. Sindrup, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00423527     History of Changes
Other Study ID Numbers: keppra3
Study First Received: January 16, 2007
Last Updated: December 17, 2009
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on October 20, 2014