Abstract
The natural course of multiple sclerosis is characterized by a high variability of pattern, relapse rate and different progression indices. They also present a dramatic impact on the interpretation of treatment trials. Reports, based on uncontrolled observations are therefore of little value. Currently it is generally accepted that a proper treatment trial should be double blinded and, although probably controversial, that it should be compared with a group of MS patients treated with placebo. Currently MS is considered as a generalized degenerative disease. The lesions are persistent, which is the reason why immunomodulatory treatment has to be started as early as possible. An alternative approach, somewhat suggestive for the use of placebo trials, seems to be a comparison of proposed new drug therapy group with a group of patients treated with a generally accepted reference drug.
Keywords: Multiple sclerosis, clinical trial, placebo, pathophysiology, reference drug, degenerative disease, T cell-mediated autoimmune, T2-weighted scans, T1-weighted, gadolinium enhanced, EDSS scale
Reviews on Recent Clinical Trials
Title: Clinical Trials in Relapsing-Remitting Multiple Sclerosis /A New Proposal for Dealing with Basic Problems and Restrictions/
Volume: 6 Issue: 3
Author(s): Mieczyslaw Wender and Grazyna Michalowska-Wender
Affiliation:
Keywords: Multiple sclerosis, clinical trial, placebo, pathophysiology, reference drug, degenerative disease, T cell-mediated autoimmune, T2-weighted scans, T1-weighted, gadolinium enhanced, EDSS scale
Abstract: The natural course of multiple sclerosis is characterized by a high variability of pattern, relapse rate and different progression indices. They also present a dramatic impact on the interpretation of treatment trials. Reports, based on uncontrolled observations are therefore of little value. Currently it is generally accepted that a proper treatment trial should be double blinded and, although probably controversial, that it should be compared with a group of MS patients treated with placebo. Currently MS is considered as a generalized degenerative disease. The lesions are persistent, which is the reason why immunomodulatory treatment has to be started as early as possible. An alternative approach, somewhat suggestive for the use of placebo trials, seems to be a comparison of proposed new drug therapy group with a group of patients treated with a generally accepted reference drug.
Export Options
About this article
Cite this article as:
Wender Mieczyslaw and Michalowska-Wender Grazyna, Clinical Trials in Relapsing-Remitting Multiple Sclerosis /A New Proposal for Dealing with Basic Problems and Restrictions/, Reviews on Recent Clinical Trials 2011; 6 (3) . https://dx.doi.org/10.2174/157488711796575586
DOI https://dx.doi.org/10.2174/157488711796575586 |
Print ISSN 1574-8871 |
Publisher Name Bentham Science Publisher |
Online ISSN 1876-1038 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
Novel Targets for Drugs in Schizophrenia
CNS & Neurological Disorders - Drug Targets TRP Channel Gating Physiology
Current Topics in Medicinal Chemistry Omega-3 Fatty Acids: Role in the Prevention and Treatment of Psychiatric Disorders
Current Psychiatry Reviews Effects of an Acute Treatment with L-Thyroxine on Memory, Habituation, Danger Avoidance, and on Na+, K+-ATPase activity in Rat Brain
Current Neurovascular Research Abnormal Functional and Structural Asymmetry as Biomarker for Schizophrenia
Current Topics in Medicinal Chemistry Bedside Balance Testing in Elderly People
Current Aging Science Microglia-Neuron Interaction in Inflammatory and Degenerative Diseases: Role of Cholinergic and Noradrenergic Systems
CNS & Neurological Disorders - Drug Targets Metabolic Syndrome, Mild Cognitive Impairment and Dementia
Current Alzheimer Research Activity-Dependent Neurorehabilitation Beyond Physical Trainings: “Mental Exercise” Through Mirror Neuron Activation
CNS & Neurological Disorders - Drug Targets TLR3 and TLR4 But not TLR2 are Involved in Vogt-Koyanagi- Harada Disease by Triggering Proinflammatory Cytokines Production Through Promoting the Production of Mitochondrial Reactive Oxygen Species
Current Molecular Medicine Neurodevelopmental Animal Models of Schizophrenia: Effects on Prepulse Inhibition
Current Molecular Medicine Cholinesterase Inhibitors Slow Decline in Executive Functions, Rather than Memory, in Alzheimers Disease: A 1-Year Observational Study in the Sunnybrook Dementia Cohort
Current Alzheimer Research Mesenchymal Stem Cells as a Source of Dopaminergic Neurons: A Potential Cell Based Therapy for Parkinson's Disease
Current Stem Cell Research & Therapy Mechanistic Approach to Understanding Psychosis Risk in Velocardiofacial Syndrome
Current Pediatric Reviews Implications for CNS Repair of Redox Modulation of Cell Survival, Division and Differentiation
Current Alzheimer Research A Survey on the Applications of Implantable Micropump Systems in Drug Delivery
Current Drug Delivery AMPA Receptor Antagonists: Potential Therapeutic Applications
Recent Patents on CNS Drug Discovery (Discontinued) Catechol-O-Methyl Transferase as a Drug Target for Schizophrenia
CNS & Neurological Disorders - Drug Targets Chemistry and Effects of Brainstem Acting Drugs
Central Nervous System Agents in Medicinal Chemistry Ophthalmological and Otological Manifestations in the Antiphospholipid Syndrome
Current Rheumatology Reviews