OBJECTIVE: To evaluate the effect of treatment with the antiherpes drug @entity6933 on MRI-evident lesions in @entity1 with relapsing-remitting @entity15 in a phase 2, randomized, double-blind, placebo-controlled study. BACKGROUND: It has been postulated from virologic studies that herpesvirus infection could play a role in the progression of @entity15 . METHODS: @entity1 were eligible for the study if they had had two or more @entity15 relapses in the 2-year period before enrollment. Seventy @entity1 with Expanded Disability Status Scale scores of 0 to 5.5 were randomly assigned to receive 1 gram of @entity6933 (n = 36) or placebo (n = 34) three times daily for 24 weeks. @entity1 underwent MRI every fourth week for 32 weeks: twice during pretreatment, six times during treatment, and once after treatment. Scoring of @entity16 was performed at the start and end of the treatment period. The primary endpoint was the number of new active MRI-evident lesions over 24 weeks of treatment. Secondary endpoints included other MRI measures and clinical endpoints. RESULTS: The mean number of new active lesions +/- SD per @entity1 during 24 weeks of treatment with @entity6933 was 11.9 +/- 17.6 and that during placebo treatment was 14.5 +/- 21.4. A protocol-planned exploratory analysis stratified @entity1 according to baseline activity; this analysis showed that @entity1 with high levels of disease activity in the @entity6933 treatment group (n = 17) developed fewer new active lesions per scan than did those in the placebo treatment group (n = 11). The median number (Q(1), Q(3) range) of active lesions was 2.0 (1.38, 3.96) in the @entity6933 treatment group and 6.5 (2.63, 9.0) in the placebo treatment group. CONCLUSIONS: @entity6933 treatment did not reduce the formation of active lesions in @entity1 with relapsing-remitting @entity15 who had two or more relapses during the previous 2-year period. In a subgroup of @entity1 with high levels of disease activity who had more than one active MRI-evident lesion during 4 weeks, @entity6933 treatment was associated with a reduced number of new active MRI-evident lesions and with an increase in the number of scans free of new active lesions. The results of the exploratory subgroup analysis provide support for further studies of antiherpes therapy for @entity1 with @entity15 and high levels of MRI-evident disease activity.

A randomized, double-blind, placebo-controlled MRI study of anti-herpes virus therapy in XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity16 :: ('MESH:D009422', 'Disease') :: ['neurologic disability'] @entity15 :: ('MESH:D009103', 'Disease') :: ['MS'] @entity6933 :: ('MESH:C084555', 'Chemical') :: ['Valacyclovir', 'valacyclovir']
@entity15 :: (MESH:D009103,Disease) :: ['MS']
