Lamictal in the Treatment of Post-Herpetic Neuralgia

NCT ID: NCT00295776

Last Updated: 2013-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Brief Summary

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

Detailed Description

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Conditions

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Neuralgia, Postherpetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Interventions

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Lamictal in the treatment of Post-Herpetic Neuralgia

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Perry K. Richardson, M.D.

Role: PRINCIPAL_INVESTIGATOR

The George Washington University Medical Faculty Associates

Locations

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Medical Faculty Associates

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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Lamictal PHN

Identifier Type: -

Identifier Source: org_study_id

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