The Effect of Levetiracetam on the Postmastectomy Pain Syndrome - Full Text View

Sponsored by:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00262262

Purpose

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

Condition	Intervention
Postoperative Pain	Drug: Levetiracetam (drug)

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

Pain relief [ Time Frame: After 1 month treatment ]

Secondary Outcome Measures:

Pain intensity measured daily on numeric rating scales [ Time Frame: During treatment periods ]

Enrollment:	25
Study Start Date:	March 2004
Study Completion Date:	September 2006

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262262

Locations

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

Sponsors and Collaborators

Odense University Hospital

Investigators

Study Director:	Ole J Vilholm, MD	Department of neurology, Odense University Hospital, Denmark
Principal Investigator:	Søren H Sindrup, Professor MD	Department of neurology, Odense University Hospital, Denmark
Study Chair:	Søren Cold, MD	Department of oncology, Odense University Hospital, Denmark
Study Chair:	Lars Rasmussen, MD	Department of surgery, Odense University Hospital, Denmark

More Information

Study ID Numbers:	KIIS, PubliRC CNS 085 TA 1007 LEV
Study First Received:	December 5, 2005
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00262262
Health Authority:	Denmark: Ethics Committee

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Piracetam

Etiracetam
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Nootropic Agents
Pathologic Processes
Therapeutic Uses
Physiological Effects of Drugs
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009