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Lamictal in the Treatment of Post-Herpetic Neuralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00295776
Recruitment Status : Terminated (enrollment difficult due to inclusion/exclusion criteria/protocol requirements)
First Posted : February 24, 2006
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
George Washington University

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

Condition or disease Intervention/treatment Phase
Neuralgia, Postherpetic Drug: Lamictal in the treatment of Post-Herpetic Neuralgia Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: Lamictal in the Treatment of Post-Herpetic Neuralgia-A Safety, Efficacy,Randomized, Double Blind, Placebo Controlled, Cross-Over Study
Study Start Date : February 2005
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
Drug Information available for: Lamotrigine





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295776


Locations
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United States, District of Columbia
Medical Faculty Associates
Washington DC, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
GlaxoSmithKline
Investigators
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Principal Investigator: Perry K. Richardson, M.D. The George Washington University Medical Faculty Associates

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Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT00295776    
Other Study ID Numbers: Lamictal PHN
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: February 2005
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:
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Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Lamotrigine
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Antipsychotic Agents
Sodium Channel Blockers