Reduction of Postherpetic Neuralgia in Herpes Zoster

NCT01250561 | Completed DMC

• 1 other identifier: CCS-06-001
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster; Post-herpetic Neuralgia

Keywords

gabapentin; valacyclovir; phn; shingles

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with zoster pain at 6 months

Secondary Outcomes (1)

• Proportion of patients with zoster pain at 4 months

Interventions

Gabapentin DRUG

gabapentin 300mg/day, titrated up weekly to max tolerated dose or 3600mg/day (whichever is lower), for 4-9 weeks

Valacyclovir DRUG

valacyclovir 1000mg three-times daily x 7 days

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Clinical Studies, Texas: lead

Study Sites (1)

Center for Clinical Studies

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Lapolla W, Digiorgio C, Haitz K, Magel G, Mendoza N, Grady J, Lu W, Tyring S. Incidence of postherpetic neuralgia after combination treatment with gabapentin and valacyclovir in patients with acute herpes zoster: open-label study. Arch Dermatol. 2011 Aug;147(8):901-7. doi: 10.1001/archdermatol.2011.81. Epub 2011 Apr 11.

  PMID: 21482862 DERIVED

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic

Interventions

Gabapentin; Valacyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stephen Tyring, MD, PhD

  Center for Clinical Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 1, 2010
• Study Start: February 1, 2002
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: December 1, 2010

Record last verified: 2010-11

Locations

US (1)