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Multiple Sclerosis Therapeutics, Second Edition PDF

867 Pages·2002·8.14 MB·English
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Multiple Sclerosis Therapeutics Second edition Multiple Sclerosis Therapeutics Second edition Edited by Jeffrey A Cohen MD Mellen Center for Multiple Sclerosis Treatment and Research The Cleveland Clinic Foundation Cleveland Ohio USARichard A Rudick MD Mellen Center for Multiple Sclerosis Treatment and Research The Cleveland Clinic Foundation Cleveland Ohio USA Prefaces written by Henry McFarland MD Chief, Immunology Branch National Institute of Neurological Disorders and Stroke National Institute of Health Bethesda MD USA LONDON AND NEW YORK © 1999, 2003, Martin Dunitz Ltd, a member of the Taylor & Francis Group First edition published in the United Kingdom in 1999 by Martin Dunitz Ltd, The Livery House, 7–9 Pratt Street, London NW1 0AE Tel: +44 (0) 20 74822202 Fax: +44 (0) 20 72670159 E-mail: Contents Contributors x Preface to first edition xxii Preface to second edition xxv Acknowledgements xxvii I Introduction 1 Aspects of multiple sclerosis that relate to clinical trial design and treatment 3 Jeffrey A Cohen and Richard A Rudick II Clinical trial methodology 2 Measures of neurologic impairment and disability in multiple sclerosis 23 Gary R Cutter 3 Assessment of neuropsychological function in multiple sclerosis 38 Jill S Fischer 4 Health-related quality of life assessment in multiple sclerosis 66 Deborah M Miller 5 Magnetic resonance imaging in multiple sclerosis: an overview 86 David H Miller 6 Measures of gadolinium enhancement in multiple sclerosis 103 Jack H Simon 7 Measures of magnetization transfer in multiple sclerosis 136 Massimo Filippi, Marco Rovaris, Joseph C McGowan and Carla Tortorella 8 Measures of T1 and T2 relaxation in multiple sclerosis 176 Marianne AA van Walderveen and Frederick Barkhof 9 Measurement of central nervous system atrophy in multiple sclerosis 197 Elizabeth Fisher and Richard A Rudick 10 Measures to quantify axonal damage in vivo based on magnetic resonance 220 spectroscopy in multiple sclerosis Douglas L Arnold and Paul M Matthews 11 Functional imaging in multiple sclerosis 235 Nancy L Sicotte 12 Use of cost analyses to improve our understanding of the therapeutic trade- 251 offs for multiple sclerosis Elizabeth D Kulas and Kathryn Whetten-Goldstein 13 Ethical considerations in multiple sclerosis clinical trials 261 William Pryse-Phillips 14 The process of drug development and approval in the USA, the European 272 Union and Canada Nadine Cohen, Ann Dodds-Frerichs, Tammy Phinney and John Watson 15 Sponsors, monitoring committees and investigators: the investigator’s 288 perspective Fred D Lublin and Stephen C Reingold 16 Guidelines for clinical trials of new therapeutic agents in multiple sclerosis: 292 reporting extended results from phase III clinical trials Donald E Goodkin, Stephen C Reingold, William A Sibley, Jerry S Wolinsky, Henry F McFarland, Diane L Cookfair and Fred D Lublin 17 The failed clinical trial in multiple sclerosis 297 Lael A Stone, Richard A Rudick and Nancy D Richert 18 The challenge of long-term studies in multiple sclerosis: use of pooled data, 308 historical controls, and observational studies to determine efficacy John H Noseworthy 19 Emerging concepts of pathogenesis: relationship to MS therapies 321 Jorge R Oksenberg, Sergio E Baranzini and Stephen L Hauser III Clinical trials of disease-modifying therapy 20 Interferons in relapsing-remitting multiple sclerosis 360 Ludwig Kappos 21 Interferons in secondary progressive multiple sclerosis 386 Ruth Ann Marrie and Jeffrey A Cohen 22 Biological responses to type I interferons: relationship to therapeutic effects 402 in multiple sclerosis Richard M Ransohoff 23 Glatiramer acetate as therapy for multiple sclerosis 418 Corey C Ford 24 Use of mitoxantrone to treat multiple sclerosis 450 Gilles Edan, Sean Patrick Morrissey and Hans-Peter Hartung 25 Intravenous immunoglobulin to treat multiple sclerosis 478 Franz Fazekas, Siegrid Strasser-Fuchs, Ralf Gold and Otto R Hommes 26 Therapeutic plasma exchange for multiple sclerosis 495 Brian G Weinshenker and Mark Keegan 27 Treatment of multiple sclerosis with methylprednisolone 512 Robert J Fox and R Philip Kinkel 28 Cyclophosphamide treatment of multiple sclerosis 536 Derek R Smith and Howard L Weiner 29 Treatment of multiple sclerosis by hematopoietic stem cell transplantation 558 Richard K Burt, Bruce Cohen, Lorri Lobeck, William H Burns and Christopher Bredeson 30 Emerging disease-modifying therapies for multiple sclerosis 572 Karim Makhlouf and Samia J Khoury 31 Combination therapies in multiple sclerosis 581 Christian Confavreux 32 Sex hormones and other pregnancy-related factors with therapeutic 593 potential in multiple sclerosis Rhonda R Voskuhl 33 Complementary and alternative treatments in multiple sclerosis 609 Vijayshree Yadav and Dennis N Bourdette IV Disease-modifying drug therapy in clinical practice 34 Disease-modifying drug therapy for multiple sclerosis in clinical practice 624 Lawrence M Samkoff and Andrew D Goodman 35 Treatment for patients with primary progressive multiple sclerosis 646 Siobhan M Leary and Alan J Thompson 36 Fatigue in multiple sclerosis 657 Lauren B Krupp 37 Management of spasticity in multiple sclerosis 669 François A Bethoux 38 Management of bladder and sexual dysfunction in multiple sclerosis 682 Scott E Litwiller 39 Treatment of disorders of mood and affect in multiple sclerosis 717 Sarah L Minden, Melissa Frumin and Jane L Erb 40 Treatment of pain, paresthesias, and paroxysmal disorders in multiple 757 sclerosis Marco A Rizzo 41 Treatment of tremor caused by multiple sclerosis 775 Anwar Ahmed, Jorge A Gonzalez-Martinez and Erwin B Montgomery 42 Management of cognitive impairment in multiple sclerosis 788 Steven R Schwid 43 Rehabilitation in multiple sclerosis patients 802 François A Bethoux

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