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Levetiracetam for Painful Polyneuropathy

This study has been completed.
Information provided by:
Odense University Hospital Identifier:
First received: February 1, 2006
Last updated: December 17, 2009
Last verified: January 2006
Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy

Condition Intervention Phase
Painful Polyneuropathy 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 the Effect of Levetiracetam on Painful Polyneuropathy

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 in each period) [ Time Frame: Daily ]

Secondary Outcome Measures:
  • Pain rated on 0 to 10 point numeric rating scales [ Time Frame: Daily ]
  • Pain subtypes rated on 0 to 10 point numeric rating scales [ Time Frame: Daily ]
  • Bruch-evoked pain [ Time Frame: Baseline and end of each treament period ]
  • Pin-prick evoked pain [ Time Frame: Baseline and end of each treatment period ]
  • Cold evoked pain [ Time Frame: Baseline and end of each treatment period ]
  • Health related quality of life(SF-36) [ Time Frame: Baseline and end of each treatment period ]
  • Pain related sleep disturbance [ Time Frame: Daily ]
  • Use of escape medication [ Time Frame: Daily ]

Estimated Enrollment: 40
Study Start Date: January 2006
Study Completion Date: October 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: levetiracetam
    Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 20 to 0 years
  • painful symptoms of polyneuropathy for at least 6 months
  • confirmed diagnosis of polyneuropathy
  • baseline pain score of 4 or more (0 to 10 point scale)
  • pain at least 4 days a week
  • adequate anticonceptive treatment for women with childbearing potential
  • informed consent

Exclusion Criteria:

  • other cause of pain
  • previous allergic reactions towards levetiracetam
  • known adverse drug reactions 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 identifier: NCT00286260

Department of Neurology, Odense University Hospital
Odense C, Denmark, DK-5000
Sponsors and Collaborators
Odense University Hospital
Study Chair: Søren H Sindrup, Professor Department of Neurology, Odense Unviersity Hospital
  More Information

Responsible Party: Professor Søren H. Sindrup, Odense University Hospital Identifier: NCT00286260     History of Changes
Other Study ID Numbers: keppra2
Study First Received: February 1, 2006
Last Updated: December 17, 2009

Keywords provided by Odense University Hospital:
neuropathic pain

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on August 22, 2017