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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Levetiracetam (drug)

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Fyn
    • Odense, Fyn, Denmark, 5000
      • Department of neurology, Odense Universityhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain relief	After 1 month treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain intensity measured daily on numeric rating scales	During treatment periods

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Study Director: Ole J Vilholm, MD, Odense University Hospital; Principal Investigator: Søren H Sindrup, Professor MD, Odense University Hospital; Study Chair: Søren Cold, MD, Department of Oncology, Odense University Hospital, Denmark; Study Chair: Lars Rasmussen, MD, Department of surgery, Odense University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: December 5, 2005
• First Submitted That Met QC Criteria: December 5, 2005
• First Posted (Estimate): December 6, 2005

Study Record Updates

• Last Update Posted (Estimate): November 26, 2007
• Last Update Submitted That Met QC Criteria: November 21, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: KIIS; PubliRC CNS 085 TA 1007 LEV