Lamictal in the Treatment of Post-Herpetic Neuralgia

This study has been terminated.

(enrollment difficult due to inclusion/exclusion criteria/protocol requirements)

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

George Washington University

ClinicalTrials.gov Identifier:

NCT00295776

First received: February 22, 2006

Last updated: March 11, 2013

Last verified: February 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

February 22, 2006

Last Updated Date

March 11, 2013

Start Date ^ICMJE

February 2005

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00295776 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind

Condition ^ICMJE

Neuralgia, Postherpetic

Intervention ^ICMJE

Drug: Lamictal in the treatment of Post-Herpetic Neuralgia

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

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

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00295776

Other Study ID Numbers ^ICMJE

Lamictal PHN

Has Data Monitoring Committee

Not Provided

Responsible Party

George Washington University

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

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