Status:
COMPLETED
The Effect of Levetiracetam on the Postmastectomy Pain Syndrome
Lead Sponsor:
Odense University Hospital
Conditions:
Postoperative Pain
Eligibility:
FEMALE
18+ years
Phase:
NA
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00262262
Start Date
March 1 2004
End Date
September 1 2006
Last Update
November 26 2007
Active Locations (1)
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1
Department of neurology, Odense Universityhospital
Odense, Fyn, Denmark, 5000