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Levetiracetam for Painful Polyneuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00286260
First Posted: February 3, 2006
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
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
  Eligibility

Information from the National Library of Medicine

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

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
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): NCT00286260


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

Responsible Party: Professor Søren H. Sindrup, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00286260     History of Changes
Other Study ID Numbers: keppra2
First Submitted: February 1, 2006
First Posted: February 3, 2006
Last Update Posted: December 18, 2009
Last Verified: January 2006

Keywords provided by Odense University Hospital:
polyneuropathy
neuropathic pain
levetiracetam

Additional relevant MeSH terms:
Pain
Polyneuropathies
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs