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The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00262262
First received: December 5, 2005
Last updated: November 21, 2007
Last verified: November 2007
History of Changes

December 5, 2005
November 21, 2007
March 2004
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Pain relief [ Time Frame: After 1 month treatment ]
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Complete list of historical versions of study NCT00262262 on ClinicalTrials.gov Archive Site
Pain intensity measured daily on numeric rating scales [ Time Frame: During treatment periods ]
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The Effect of Levetiracetam on the Postmastectomy Pain Syndrome
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2006
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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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00262262
KIIS, PubliRC CNS 085 TA 1007 LEV
No
Not Provided
Odense University Hospital
Not Provided
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
Odense University Hospital
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP