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The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

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. Identifier: NCT00262262
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : November 26, 2007
Information provided by:
Odense University Hospital

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Levetiracetam (drug) Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Levetiracetam on the Postmastectomy Pain Syndrome
Study Start Date : March 2004
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Levetiracetam (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 Name: Keppra, Levetiracetam

Primary Outcome Measures :
  1. Pain relief [ Time Frame: After 1 month treatment ]

Secondary Outcome Measures :
  1. Pain intensity measured daily on numeric rating scales [ Time Frame: During treatment periods ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00262262

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Department of neurology, Odense Universityhospital
Odense, Fyn, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
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Study Director: Ole J Vilholm, MD Department of Neurology, Odense University Hospital, Denmark
Principal Investigator: Søren H Sindrup, Professor MD Department of Neurology, Odense University Hospital, Denmark
Study Chair: Søren Cold, MD Department of oncology, Odense University Hospital, Denmark
Study Chair: Lars Rasmussen, MD Department of surgery, Odense University Hospital, Denmark

Layout table for additonal information Identifier: NCT00262262     History of Changes
Other Study ID Numbers: KIIS
PubliRC CNS 085 TA 1007 LEV
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: November 26, 2007
Last Verified: November 2007
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Nootropic Agents