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The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

NCT00262262 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2007-11-26

No results posted yet for this study

Summary

The aim of this study is determine whether or not the antiepileptic drug Levetiracetam is an effective treatment of the postmastectomy pain syndrome.

Conditions

  • Postoperative Pain

Interventions

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.

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Ole J Vilholm, MD · Odense University Hospital

  • Søren H Sindrup, Professor MD · Odense University Hospital

  • Søren Cold, MD · Department of oncology, Odense University Hospital, Denmark

  • Lars Rasmussen, MD · Department of surgery, Odense University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Completion
2006-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00262262 on ClinicalTrials.gov