This textbook examines the most important aspects of multiple sclerosis that impact on clinical trial design, on the development of new disease therapies and on patient care. The international team of contributors discuss the clinical course of multiple sclerosis, its clinical heterogeneity, the presence of subclinical disease activity which occurs during the early stages of the disease. Multiple sclerosis presents clinical challenges: from unexpected and irregular relapses to profressive deterioration.
1. Aspects Of Multiple Sclerosis that Relate to Clinical Trial Design and Treatment 2. Clinical Trial Methodology 3. Measures of Impairment and Disability 4. Measures of Neuropsychological Function 5. Measures of Quality of Life 6. Measures of Gadolinium Enhancement 7. Measures of Magnetization Transfer 8. Measures of T1 and T2 Relaxation 9. Measures of Brain and Spinal Cord Atrophy 10. Measures for Quantification of Axonal Damage in vivo Based on MRS Imaging 11. Body Fluid Markers for Disease Course and Activity 12. The Use of Cost Analyses to Improve Our Understanding of the Therapeutic Trade-offs for Multiple Sclerosis 13. The Application of Ethical Principles to Clinical Trials 14. The Process of Drug Approval and Labeling in the USA 15. The Process of Drug Approval and Labeling in Canada 16. The Process of Drug Approval in the European Union 17. Sponsors, Monitoring Committees, The Investigator's Perspective 18. Standardized Reporting of Randomized Controlled Multiple Sclerosis Clinical Trials 19. The Negative Clinical Trial: Failure or Opportunity 20. Emerging Concepts of Pathogenesis: Relationship to Multiple Sclerosis Therapies 21. Interferons 22. Glatiramer Acetate 23. Cladribine 24. Intravenous Immunoglobulin 25. Therapeutic Plasma Exchange 26. Mitoxantrone 27. Methylprednisolone 28. Hematopoietic Stem Cell Transplantation 29. Emerging Disease-modifying Therapies 30. Combination Therapies 31. To Treat or Not to Treat 32. Treatment for Patients with Relapsing-remitting Multiple Sclerosis 33. Treatment for Patients With Secondary Progressive Multiple Sclerosis 34. Treatment for Patients With Primary Progressive and Progressive-relapsing Multiple Sclerosis 35. Treatment of Fatigue in Multiple Sclerosis 36. Treatment of Spasticity 37. Treatment of Bladder and Sexual Dysfunction 38. Treatment of Mood and Affective Disorders 39. Treatment of Chronic Pain 40. Treatment of Paroxysmal Symptoms 41. Treatment of Tremor