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Completed

NCT Number: NCT00286260

Levetiracetam for Painful Polyneuropathy

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

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Key information

Conditions

Painful Polyneuropathy Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Neurology, Odense University Hospital

Odense C, DK-5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks

Primary outcomes

  1. 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 outcomes

  1. Pain rated on 0 to 10 point numeric rating scales

    Time frame: Daily

  2. Pain subtypes rated on 0 to 10 point numeric rating scales

    Time frame: Daily

  3. Bruch-evoked pain

    Time frame: Baseline and end of each treament period

  4. Pin-prick evoked pain

    Time frame: Baseline and end of each treatment period

  5. Cold evoked pain

    Time frame: Baseline and end of each treatment period

  6. Health related quality of life(SF-36)

    Time frame: Baseline and end of each treatment period

  7. Pain related sleep disturbance

    Time frame: Daily

  8. Use of escape medication

    Time frame: Daily

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 3, 2006
Registry last updated
Dec 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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