Back to resultsThe Effect of Levetiracetam on the Postmastectomy Pain Syndrome
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Levetiracetam (drug)
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Department of neurology, Odense Universityhospital
Outcomes
Primary Outcome Measures
Pain relief
Secondary Outcome Measures
Pain intensity measured daily on numeric rating scales
Full Information
NCT ID
NCT00262262
First Posted
December 5, 2005
Last Updated
November 21, 2007
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00262262
Brief Title
The Effect of Levetiracetam on the Postmastectomy Pain Syndrome
Official Title
The Effect of Levetiracetam on the Postmastectomy Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levetiracetam (drug)
Other Intervention Name(s)
Keppra, Levetiracetam
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain relief
Time Frame
After 1 month treatment
Secondary Outcome Measure Information:
Title
Pain intensity measured daily on numeric rating scales
Time Frame
During treatment periods
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole J Vilholm, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Søren H Sindrup, Professor MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Søren Cold, MD
Organizational Affiliation
Department of oncology, Odense University Hospital, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lars Rasmussen, MD
Organizational Affiliation
Department of surgery, Odense University Hospital, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Department of neurology, Odense Universityhospital
City
Odense
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Effect of Levetiracetam on the Postmastectomy Pain Syndrome
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