The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

NCT00262262 | Completed

• 2 other identifiers: KIISPubliRC CNS 085 TA 1007 LEV
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain relief

  After 1 month treatment

Secondary Outcomes (1)

• Pain intensity measured daily on numeric rating scales

  During treatment periods

Interventions

Levetiracetam (drug) 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.

Also known as: Keppra, Levetiracetam

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of neurology, Odense Universityhospital

Odense, Fyn, 5000, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Levetiracetam; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ole J Vilholm, MD

  Odense University Hospital

  STUDY DIRECTOR

• Søren H Sindrup, Professor MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Søren Cold, MD

  Department of oncology, Odense University Hospital, Denmark

  STUDY CHAIR

• Lars Rasmussen, MD

  Department of surgery, Odense University Hospital, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2005
• First Posted: December 6, 2005
• Study Start: March 1, 2004
• Study Completion: September 1, 2006
• Last Updated: November 26, 2007

Record last verified: 2007-11

Locations

DK (1)