Lamictal in the Treatment of Post-Herpetic Neuralgia

March 11, 2013 updated by: George Washington University

Lamictal in the Treatment of Post-Herpetic Neuralgia-A Safety, Efficacy,Randomized, Double Blind, Placebo Controlled, Cross-Over Study

To assess the efficacy of Lamictal for the treatment of pain and reduction of allodynia in patients with post herpetic neuralgia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington DC, District of Columbia, United States, 20037
        • Medical Faculty Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients will be over the age of 18,
  • Need to have a diagnosis of Post-Herpetic Neuralgia,
  • Minimum of 4 on the Likert Pain Scale,
  • If currently taking TCA and/or Gabapentin, need to have been on stable dose for minimum of 4 weeks

Exclusion Criteria:

  • Currently on any antiepileptic drugs (AED), except for Gabapentin.
  • Currently taking opioid or unwilling to washout prior to the study,
  • Pregnant and lactating,
  • Have active severe systemic disease,
  • History of Stevens-Johnson syndrome or TEN,
  • Clinically significant abnormal lab values,
  • Known drug allergy to Lamictal,
  • Patients on Fibrates (Tricor and Lopid),
  • History of major psychiatric disturbance and substance abuse.
  • Valproate due to increase chances of severe rash,
  • Lidocaine Patch,
  • Use of hormonal contraceptives (birth control pills, patch, ring, injection)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Perry K. Richardson, M.D., The George Washington University Medical Faculty Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

February 22, 2006

First Submitted That Met QC Criteria

February 22, 2006

First Posted (ESTIMATE)

February 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 13, 2013

Last Update Submitted That Met QC Criteria

March 11, 2013

Last Verified

February 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lamictal PHN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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