A randomized clinical trial of valacyclovir in multiple sclerosis
| Autor: | J E Whitman, Otto Rapalino, M Shieh, J B Zabriskie, Dharam V. Ablashi, Randall C. Edgell, C. Plank, B Shahan, J E Friedman, Robert D. Zimmerman, D Sheng |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Herpesvirus 6 Human Acyclovir Roseolovirus Infections Pilot Projects Placebo Antiviral Agents law.invention Disability Evaluation 03 medical and health sciences Multiple Sclerosis Relapsing-Remitting 0302 clinical medicine Randomized controlled trial law Internal medicine medicine Humans 030212 general & internal medicine Aciclovir Gait Aged Expanded Disability Status Scale medicine.diagnostic_test business.industry Multiple sclerosis virus diseases Valine Magnetic resonance imaging Middle Aged Multiple Sclerosis Chronic Progressive medicine.disease Magnetic Resonance Imaging Surgery Valaciclovir Clinical trial Immunoglobulin M Neurology Valacyclovir Female Neurology (clinical) business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Multiple Sclerosis Journal. 11:286-295 |
| ISSN: | 1477-0970 1352-4585 |
| DOI: | 10.1191/1352458505ms1185oa |
| Popis: | Objective: The human Herpesvirus type-6 (HHV-6) has been implicated in multiple sclerosis (MS). Valacyclovir is an antiviral agent with an excellent safety profile. A two-year, placebo-controlled, double-blind study was conducted to (1) ascertain if high-dose, prolonged treatment with valacyclovir would be safe and (2) observe if valacyclovir would delay the progression of MS clinically or by magnetic resonance imaging (MRI). Design/methods: Fifty-eight patients were stratified as to severity and randomly assigned to receive valacyclovir (3000 mg/day) or placebo for a period of two years. Patients were followed clinically over the two-year period by means of the Expanded Disability Status Scale (EDSS), the Ambulation Index (AI) and brain MRI scans. Patients underwent routine lab studies every three months. Patients continued on the medication for two years unless they had a sustained progression or repeated exacerbations. Results: No patient discontinued the study due to side effects or toxicity. In Relative Ranking of Progression, time to first attack, attack rate, and time to withdrawal there were trends (but not statistically significant) toward drug effect over placebo in the Severe clinical category. MRI evaluation showed no significant drug effect. Conclusions: Although not statistically significant, positive trends were detected for acyclovir by clinical measures, but not by MRI. |
| Databáze: | OpenAIRE |
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