The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

NCT ID: NCT00262262

Last Updated: 2007-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2006-09-30

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Keppra, Levetiracetam

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Ole J Vilholm, MD

Role: STUDY_DIRECTOR

Odense University Hospital

Søren H Sindrup, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Søren Cold, MD

Role: STUDY_CHAIR

Department of oncology, Odense University Hospital, Denmark

Lars Rasmussen, MD

Role: STUDY_CHAIR

Department of surgery, Odense University Hospital, Denmark

Locations

Department of neurology, Odense Universityhospital

Odense, Fyn, Denmark

Countries

Denmark

Other Identifiers

PubliRC CNS 085 TA 1007 LEV

Identifier Type: -

Identifier Source: secondary_id

KIIS

Identifier Type: -

Identifier Source: org_study_id