Lamictal in the Treatment of Post-Herpetic Neuralgia - Tabular View

Tracking Information

First Received Date ^ICMJE

February 22, 2006

Last Updated Date

February 22, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Lamictal in the Treatment of Post-Herpetic Neuralgia

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Placebo Control, Crossover Assignment

Condition ^ICMJE

Neuralgia, Postherpetic

Intervention ^ICMJE

Drug: Lamictal in the treatment of Post-Herpetic Neuralgia

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Elizabeth Kingery, RN

202-741-2729

ekingery@mfa.gwu.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00295776

Responsible Party

Study ID Numbers ^ICMJE

Lamictal PHN

Study Sponsor ^ICMJE

George Washington University

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Perry K. Richardson, M.D.

The George Washington University Medical Faculty Associates

Information Provided By

George Washington University

Verification Date

February 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP