Lamictal in the Treatment of Post-Herpetic Neuralgia

This study has been terminated.

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

First Received on February 22, 2006. Last Updated on June 21, 2011 History of Changes

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

Further study details as provided by George Washington University:

Study Start Date:

February 2005

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

Locations

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

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

ClinicalTrials.gov Identifier:	NCT00295776 History of Changes
Other Study ID Numbers:	Lamictal PHN
Study First Received:	February 22, 2006
Last Updated:	June 21, 2011
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
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lamotrigine

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012