Reduction of Postherpetic Neuralgia in Herpes Zoster

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. Identifier: NCT01250561
Recruitment Status : Completed
First Posted : December 1, 2010
Last Update Posted : December 1, 2010
Information provided by:
Center for Clinical Studies, Texas

Brief Summary:
The addition of gabapentin therapy to standard antiviral treatment with valacyclovir in acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.

Condition or disease Intervention/treatment Phase
Herpes Zoster Post-herpetic Neuralgia Drug: Gabapentin Drug: Valacyclovir Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2002
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

Intervention Details:
    Drug: Gabapentin
    gabapentin 300mg/day, titrated up weekly to max tolerated dose or 3600mg/day (whichever is lower), for 4-9 weeks
    Drug: Valacyclovir
    valacyclovir 1000mg three-times daily x 7 days

Primary Outcome Measures :
  1. Proportion of patients with zoster pain at 6 months

Secondary Outcome Measures :
  1. Proportion of patients with zoster pain at 4 months

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients of 50 years of age and older.
  • Patients with a clinical diagnosis of uncomplicated herpes zoster presenting within the first 72 hours of vesicles.
  • Patients who are willing and able to comply with the requirements of the study.
  • Patients who are willing and able to give written informed consent.
  • Average pain score pre-therapy greater or equal than 4 on 10-point Likert scale.

Exclusion Criteria:

  • Sexually-active women of childbearing potential, including postmenopausal women less than 1 year since last menses, not employing adequate contraception (approved oral contraceptive, intrauterine device, barrier methods or total abstinence).
  • Pregnant females and nursing mothers.
  • Patients with immune dysfunction including congenital immune deficiency, active malignancy of any type, collagen vascular diseases, organ or bone marrow transplantations, known infection with HIV or severe atopic dermatitis.
  • Patients who have received cytotoxic drugs or immunosuppressive therapy (e.g., chronic systemic corticosteroids) within the previous 3 months.
  • Patients with evidence of cutaneous or visceral dissemination of herpes zoster infection (cutaneous dissemination is defined as > 20 discrete lesions outside adjacent dermatomes).
  • Patients who have received systemic anti-VZV medications or immunomodulatory medications (including interferon) within the previous 4 weeks.
  • Patients currently receiving probenecid.
  • Patients with impaired renal function: calculated creatinine clearance of <30 mL/min using Cockcroft and Gault formula.
  • Patients with abnormal liver function (alanine transaminase (ALT) or aspartate;transaminase (AST) levels greater than five times the upper limit of the normal range).
  • Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, famciclovir or gabapentin.
  • Patients currently receiving therapy with gabapentin or tricyclic antidepressants.
  • Patients with clinical evidence of ocular involvement of herpes zoster. Patients with herpes zoster of the ophthalmic branch of the trigeminal nerve without evidence of ocular involvement will be included.

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 identifier (NCT number): NCT01250561

United States, Texas
Center for Clinical Studies
Houston, Texas, United States, 77030
Sponsors and Collaborators
Center for Clinical Studies, Texas
Principal Investigator: Stephen Tyring, MD, PhD Center for Clinical Studies

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stephen Tyring, Center for Clinical Studies Identifier: NCT01250561     History of Changes
Other Study ID Numbers: CCS-06-001
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010

Keywords provided by Center for Clinical Studies, Texas:

Additional relevant MeSH terms:
Herpes Zoster
Neuralgia, Postherpetic
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists