Lamictal in the Treatment of Post-Herpetic Neuralgia

NCT00295776 | Terminated Phase 2

• 1 other identifier: Lamictal PHN
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuralgia, Postherpetic

Keywords

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,

Interventions

Lamictal in the treatment of Post-Herpetic Neuralgia DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• George Washington University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Stevens-Johnson Syndrome

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Perry K. Richardson, M.D.

  The George Washington University Medical Faculty Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2006
• First Posted: February 24, 2006
• Study Start: February 1, 2005
• Primary Completion: December 1, 2007
• Last Updated: March 13, 2013

Record last verified: 2005-02

Locations

US (1)