The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00262262

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Levetiracetam (drug)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

Study Start Date :

Mar 1, 2004

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Pain relief [After 1 month treatment]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of neurology, Odense Universityhospital	Odense	Fyn	Denmark	5000

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00262262

Other Study ID Numbers:

KIIS
PubliRC CNS 085 TA 1007 LEV

First Posted:

Dec 6, 2005

Last Update Posted:

Nov 26, 2007

Last Verified:

Nov 1, 2007

Additional relevant MeSH terms:

Pain, Postoperative

Levetiracetam

Study Results

No Results Posted as of Nov 26, 2007