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Levetiracetam for Painful Polyneuropathy

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00286260
First received: February 1, 2006
Last updated: December 17, 2009
Last verified: January 2006
History of Changes
  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
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 the Effect of Levetiracetam on Painful Polyneuropathy

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain rated on 0 to 10 point numeric rating scales [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Pain subtypes rated on 0 to 10 point numeric rating scales [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Bruch-evoked pain [ Time Frame: Baseline and end of each treament period ] [ Designated as safety issue: No ]
  • Pin-prick evoked pain [ Time Frame: Baseline and end of each treatment period ] [ Designated as safety issue: No ]
  • Cold evoked pain [ Time Frame: Baseline and end of each treatment period ] [ Designated as safety issue: No ]
  • Health related quality of life(SF-36) [ 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 ]

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013