Table of contents:
Preface
Part I: Introduction 1. Aspects of Multiple Sclerosis that Relate to Clinical Trial Design and Treatment
Part II: Clinical Trial Methodology 2. Measures of Impairment and Disability 3. Assessment of Neuropsychological Function 4. Health-related Quality of Life Assessment in Multiple Sclerosis 5. Magnetic Resonance Imaging in Multiple Sclerosis: an Overview 6. Measures of Gadolinium Enhancement 7. Measures of Magnetization Transfer 8. Measures of T1 and T2 Relaxation 9. Measurement of CNS Atrophy 10. Measures to Quantify Axonal Damage In Vivo Based on Magnetic Resonance Spectroscopy 11. Functional Imaging in Multiple Sclerosis 12. The Use of Cost Analyses to Improve our Understanding of Therapeutic Trade-offs for Multiple Sclerosis 13. Ethical Considerations in Multiple Sclerosis Clinical Trials 14. The Process of Drug Development and Approval in the United States, European Union, and Canada 15. Sponsors, Monitoring Committees, and Investigators: the Investigator's Perspective 16. Guidelines for Clinical Trials of New Therapeutic Agents in Multiple Sclerosis: Reporting Extended Results from Phase III Clinical Trials 17. The Failed Clinical Trial 18. The Challenge of Long-term Studies in MS: Use of Pooled Data, Historical Controls, and Observational Studies to determine efficacy
Part III: Clinical Trials of Disease Modifying Therapy 19. Emerging Concepts of Pathogenesis: Relationship to MS Therapies 20. Interferons in Relapsing Remitting MS 21. Interferons in Secondary Progressive MS 22. Biologic Mechanisms of Action of Interferons in MS 23. Glatiramer Acetate 24. Mitoxantrone 25. Intravenous Immunoglobin to Treat Multiple Sclerosis 26. Therapeutic Plasma Exchange for Multiple Sclerosis 27. Methylprednisolone 28. Cyclophosphamide Treatment of Multiple Sclerosis 29. Treatment of Multiple Sclerosis by Hematopoietic Stem Cell Transplantation 30. Emerging Disease-modifying Therapies 31. Combination Therapies in Multiple Sclerosis 32. Sex Hormones and Other Pregnancy Related Factors with Therapeutic Potential in Multiple Sclerosis 33. Complementary and Alternative Treatments in Multiple Sclerosis
Part IV: Therapy in Clinical Practice 34. Use of Disease-modifying Drug Therapy for Relapsing Forms of MS in Clinical Practice 35. Primary Progressive MS 36. Fatigue 37. Management of Spasticity in Multiple Sclerosis 38. Bladder and Sexual Dysfunction 39. Treatment of Disorders of Mood and Affect 40. Pain and Paroxysmal Disorders 41. Tremor 42. Management of Cognitive Impairment in MS 43. Rehabilitation in Multiple Sclerosis Patients
This revised textbook examines the most important aspects of multiple sclerosis that impact on clinical trial design, on the development of new disease therapies, and, very importantly, on patient care. The international team of contributors discusses the clinical course of multiple sclerosis, its clinical heterogeneity, and the presence of subclinical disease activity which occurs during the early stages of the disease. There have been substantial advances in the field since the 1st Edition was published in 1999.
There are new chapters on functional imaging, the issues involved in long-term follow-up studies, cyclophosphamide, sex hormones and pregnancy-related factors, complementary and alternative treatments, management of cognitive impairment, treatment of pain, and rehabilitative approaches. Chapters on MS pathogenesis, imaging, the interferons, glatiramer acetate, mitoxantrone, IVIg, plasma exchange, stem cell transplantation, combination therapies, and newly-emerging treatments have been updated.
New chapters in this revised text include: functional imaging, cyclophosphamide, sex hormones, pregnancy-related factors, complementary and alternative treatments, management of cognitive impairment, treatment of pain, and rehabilitative approaches
Preface
Part I: Introduction 1. Aspects of Multiple Sclerosis that Relate to Clinical Trial Design and Treatment
Part II: Clinical Trial Methodology 2. Measures of Impairment and Disability 3. Assessment of Neuropsychological Function 4. Health-related Quality of Life Assessment in Multiple Sclerosis 5. Magnetic Resonance Imaging in Multiple Sclerosis: an Overview 6. Measures of Gadolinium Enhancement 7. Measures of Magnetization Transfer 8. Measures of T1 and T2 Relaxation 9. Measurement of CNS Atrophy 10. Measures to Quantify Axonal Damage In Vivo Based on Magnetic Resonance Spectroscopy 11. Functional Imaging in Multiple Sclerosis 12. The Use of Cost Analyses to Improve our Understanding of Therapeutic Trade-offs for Multiple Sclerosis 13. Ethical Considerations in Multiple Sclerosis Clinical Trials 14. The Process of Drug Development and Approval in the United States, European Union, and Canada 15. Sponsors, Monitoring Committees, and Investigators: the Investigator's Perspective 16. Guidelines for Clinical Trials of New Therapeutic Agents in Multiple Sclerosis: Reporting Extended Results from Phase III Clinical Trials 17. The Failed Clinical Trial 18. The Challenge of Long-term Studies in MS: Use of Pooled Data, Historical Controls, and Observational Studies to determine efficacy
Part III: Clinical Trials of Disease Modifying Therapy 19. Emerging Concepts of Pathogenesis: Relationship to MS Therapies 20. Interferons in Relapsing Remitting MS 21. Interferons in Secondary Progressive MS 22. Biologic Mechanisms of Action of Interferons in MS 23. Glatiramer Acetate 24. Mitoxantrone 25. Intravenous Immunoglobin to Treat Multiple Sclerosis 26. Therapeutic Plasma Exchange for Multiple Sclerosis 27. Methylprednisolone 28. Cyclophosphamide Treatment of Multiple Sclerosis 29. Treatment of Multiple Sclerosis by Hematopoietic Stem Cell Transplantation 30. Emerging Disease-modifying Therapies 31. Combination Therapies in Multiple Sclerosis 32. Sex Hormones and Other Pregnancy Related Factors with Therapeutic Potential in Multiple Sclerosis 33. Complementary and Alternative Treatments in Multiple Sclerosis
Part IV: Therapy in Clinical Practice 34. Use of Disease-modifying Drug Therapy for Relapsing Forms of MS in Clinical Practice 35. Primary Progressive MS 36. Fatigue 37. Management of Spasticity in Multiple Sclerosis 38. Bladder and Sexual Dysfunction 39. Treatment of Disorders of Mood and Affect 40. Pain and Paroxysmal Disorders 41. Tremor 42. Management of Cognitive Impairment in MS 43. Rehabilitation in Multiple Sclerosis Patients
This revised textbook examines the most important aspects of multiple sclerosis that impact on clinical trial design, on the development of new disease therapies, and, very importantly, on patient care. The international team of contributors discusses the clinical course of multiple sclerosis, its clinical heterogeneity, and the presence of subclinical disease activity which occurs during the early stages of the disease. There have been substantial advances in the field since the 1st Edition was published in 1999.
There are new chapters on functional imaging, the issues involved in long-term follow-up studies, cyclophosphamide, sex hormones and pregnancy-related factors, complementary and alternative treatments, management of cognitive impairment, treatment of pain, and rehabilitative approaches. Chapters on MS pathogenesis, imaging, the interferons, glatiramer acetate, mitoxantrone, IVIg, plasma exchange, stem cell transplantation, combination therapies, and newly-emerging treatments have been updated.
New chapters in this revised text include: functional imaging, cyclophosphamide, sex hormones, pregnancy-related factors, complementary and alternative treatments, management of cognitive impairment, treatment of pain, and rehabilitative approaches