NCT00031486

A Phase III Double-Blind, Placebo-Controlled Trial of Long Term Therapy of Herpes Simplex Encephalitis (HSE): An Evaluation of Valacyclovir (CASG-204)

Completed Phase 3 Results posted Last updated 10 May 2012

What this trial tests

Phase 3 trial testing Valacyclovir in Encephalitis in 91 participants. Completed in 1 February 2011.

Timeline

1 September 2000

Primary endpoint
1 June 2010

1 February 2011

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	91
Start date	1 September 2000
Primary completion	1 June 2010
Estimated completion	1 February 2011
Sites	21 locations across United States, Canada, Sweden, United Kingdom

Drugs / interventions tested

• Valacyclovir — full drug profile →
• Placebo

Conditions studied

• Encephalitis — all drugs for Encephalitis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

12 and older, any sex, with Encephalitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Survival With no or Mild Neuropsychological Impairment at 12 Months After Initiation of Study Medication as Measured by the Mattis Dementia Rating Scale (MDRS)
  Time frame: One year post therapy.
  Number of subjects who were assessed to have no or mild neuropsychological impairment at 12 months using the Mattis Dementia Rating Scale. (A score of 121 or higher refects no or mild neuropsychological impairment.) Scale is: 139-144 normal; 121-139 mild; 114-120 moderate; 87-113 severe; and \<=86 very severe.

Sponsor's own description

This study involves patients 12 years and older who have been diagnosed with herpes simplex encephalitis (HSE) by a specific laboratory test and have completed treatment or are being treated with intravenous (given through a needle inserted into a vein) acyclovir. The purpose of the study is to determine if treatment with 4 tablets, 500 milligrams each, of valacyclovir given 3 times daily by mouth for 90 days is both effective and safe after completing intravenous acyclovir treatment and if it can increase survival with or without mild impairment of the brain and mental functions. Participants will be assigned to either drug or placebo (inactive substance) randomly (by chance). Study procedures will include blood samples and lumbar punctures (procedure in which a needle is inserted into the lower back to collect cerebral spinal fluid). Subjects will participate for up to 24 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Herpes Simplex Encephalitis: Lack of Clinical Benefit of Long-term Valacyclovir Therapy.
   Gnann JW, Sköldenberg B, Hart J, Aurelius E, et al · · 2015 · cited 59× · PMID 25956891 · DOI 10.1093/cid/civ369