Lamictal in the Treatment of Post-Herpetic Neuralgia

This study is currently recruiting participants.

Verified by George Washington University, February 2005

First Received: February 22, 2006 No Changes Posted

Sponsor:	George Washington University
Collaborator:	GlaxoSmithKline
Information provided by:	George Washington University
ClinicalTrials.gov Identifier:	NCT00295776

Purpose

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

Condition	Intervention	Phase
Neuralgia, Postherpetic	Drug: Lamictal in the treatment of Post-Herpetic Neuralgia	Phase II Phase III

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	Lamictal in the Treatment of Post-Herpetic Neuralgia-A Safety, Efficacy,Randomized, Double Blind, Placebo Controlled, Cross-Over Study

Resource links provided by NLM:

MedlinePlus related topics: Shingles

Drug Information available for: Lamotrigine

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295776

Contacts

Contact: Elizabeth Kingery, RN

202-741-2729

ekingery@mfa.gwu.edu

Locations

United States, District of Columbia
Medical Faculty Associates	Recruiting
Washington, DC, District of Columbia, United States, 20037
Contact: Elizabeth Kingery, RN 202-741-2729 ekingery@mfa.gwu.edu

Sponsors and Collaborators

George Washington University

GlaxoSmithKline

Investigators

Principal Investigator:

Perry K. Richardson, M.D.

The George Washington University Medical Faculty Associates

More Information

No publications provided

Study ID Numbers:	Lamictal PHN
Study First Received:	February 22, 2006
Last Updated:	February 22, 2006
ClinicalTrials.gov Identifier:	NCT00295776 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by George Washington University:

Inclusion Criteria: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 antiepilepic 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,

Additional relevant MeSH terms:

Neuralgia, Postherpetic
Neuralgia
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Calcium Channel Blockers
Pain
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators

Signs and Symptoms
Neuromuscular Diseases
Therapeutic Uses
Peripheral Nervous System Diseases
Lamotrigine
Neurologic Manifestations
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010