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The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00262262
First Posted: December 6, 2005
Last Update Posted: November 26, 2007
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.
Information provided by:
Odense University Hospital
December 5, 2005
December 6, 2005
November 26, 2007
March 2004
Not Provided
Pain relief [ Time Frame: After 1 month treatment ]
Not Provided
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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Not Provided
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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
Not Provided

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00262262
KIIS
PubliRC CNS 085 TA 1007 LEV
No
Not Provided
Not Provided
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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