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Completed

NCT Number: NCT00262262

The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

The aim of this study is determine whether or not the antiepileptic drug Levetiracetam is an effective treatment of the postmastectomy pain syndrome.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of neurology, Odense Universityhospital

Odense, Fyn, 5000, Denmark

About this study

This study is a randomised, placebocontrolled, doubleblind study on the effect of the antiepileptic drug, levetiracetam, in patients suffering from PMPS. The treatment periods are 1 month each and the periods are separated by a 1-week washout period. The daily dose of levetiracetam is increased over a 2-week period to 3.000 mg/day. The primary effect variable is pain relief by the use of numeric rating scale. Secondary parameters are daily registration of pain performed by the patients during the treatment periods and the amount of escape medicine used (paracetamol and tramadol). Sensory testing is performed at baseline and after each treatment period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptoms characteristic for postmastectomy pain syndrome with a duration of more than 3 months and at least 6 months after the operation.
  • Neuropathic pain diagnose confirmed by abnormities in the neurological investigation and/or psychophysical sensory testing
  • Average (1 week) pain score minimum 4 on a 11 points numerical rating scale for total pain.
  • Pain present minimum 4 out of 7 days.
  • Fertile women must use anticonception.

Exclusion criteria

  • Verified og suspected other reason than mastectomy/lumpectomy for the pain.
  • Known allergic effects to levetiracetam.
  • Known sideeffects to treatment with levetiracetam.
  • Pregnancy or breast-feeding.
  • Severe disease (terminal cancer, heart failure, kidney insufficiency, severe respiratory problems)
  • Compliance problems

Treatment and study plan

Levetiracetam (drug)

Drug

The starting dose of levetiracetam was 500 mg/day and the dose was increased with 500 mg every other day to 6 tablets of 500 mg (Keppra, UCB, Belgium), divided into two doses daily corresponding to 3000 mg/day. The dose was kept at this level throughout the remaining treatment period - 4 weeks total. Six placebo tablets with identical appearance were dosed similarly to levetiracetam in the placebo phase.

Other names: Keppra, Levetiracetam

Primary outcomes

  1. Pain relief

    Time frame: After 1 month treatment

Secondary outcomes

  1. Pain intensity measured daily on numeric rating scales

    Time frame: During treatment periods

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Dec 6, 2005
Registry last updated
Nov 26, 2007

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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