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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:
[email protected] Website: http://www.dunitz.co.uk/
This edition published in the Taylor & Francis e-Library, 2005.
“To purchase your own copy of this or any of Taylor & Francis or Routledge’s collection of
thousands of eBooks please go to http://www.ebookstore.tandf.co.uk/.”
Second edition 2003
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or
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copying issued by the Copyright Licensing Agency, 90 Tottenham Court Road, London W1P
0LP.
Although every effort has been made to ensure that drug doses and other information are presented
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Neither the publishers nor the authors can be held responsible for errors or for any consequences
arising from the use of information contained herein. For detailed prescribing information or
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information or instructional material issued by the manufacturer.
A CIP record for this book is available from the British Library.

ISBN 0-203-63911-1 Master e-book ISBN

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ISBN-1-84184-226-5 (Print Edition)
Distributed in the USA by Fulfilment Center Taylor & Francis 10650 Tobben Drive
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Composition by Wearset Ltd, Boldon, Tyne & Wear

 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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 Contributors
Anwar Ahmed MD
Movement Disorders Section
Department of Neurology
Cleveland Clinic Foundation
Cleveland OH
USA

Douglas L Arnold MD
MR Spectroscopy Unit
Montréal Neurological Institute and Hospital
Montréal PQ
Canada

Sergio E Baranzini PhD

Department of Neurology
University of California at San Francisco,
School of Medicine
San Francisco CA
USA

Frederick Barkhof MD
MR Center for MS Research
Vrije Universiteit Medical Center
Amsterdam
The Netherlands

François A Bethoux MD
Staff Physician
Mellen Center for Multiple Sclerosis Treatment and Research
Cleveland Clinic Foundation
Cleveland OH
USA

Dennis N Bourdette MD
Interim Chair and Roy & Eulalia Eulalia Swank Family
Research Professor
Department of Neurology
Oregon Health & Sciences University
Portland OR
USA
 Christopher Bredeson MD
Bone Marrow Transplant Program
Department of Medicine
Medical College of Wisconsin
Milwaukee WI
USA

William H Burns MD
Professor of Medicine and Microbiology
Director, Bone Marrow Transplant Program
Medical College of Wisconsin
Milwaukee WI
USA

Richard K Burt MD
Assistant Professor of Medicine
Division of Immune Therapy and Autoimmune Disease
Northwestern University Medical School
Chicago IL
USA

Bruce Cohen MD
Department of Neurology
Northwestern University Medical School
Chicago IL
USA

Nadine Cohen PhD

Senior Vice President, Regulatory Affairs
Biogen, Inc.
Cambridge MA
USA

Christian Confavreux MD
Professor of Neurology
Head of Department, INSERM U 433
Service de Neurologie and
EDMUS Co-ordinating Center
Hôpital Neurologique
Lyon
France

Diane L Cookfair PhD

Department of Neurology
University at Buffalo, SUNY
Buffalo NY
USA

Gary R Cutter PhD

Professor of Medicine
Director, Center for Research, Design & Statistical Methods
Department of Internal Medicine
UNR School of Medicine
University of Nevada
Reno NV
USA

Ann Dodds-Frerichs MBA

Director, Regulatory Affairs Biogen, Inc.
Cambridge MA
USA

Gilles Edan
Department of Neurology
CHU Pontchaillou
Rennes
France

Jane L Erb MD
Department of Psychiatry
Brigham and Women’s Hospital
Boston MA
USA

Franz Fazekas MD
Professor of Neurology
Department of Neurology and
MRI Centre
Karl-Franzens-Universität Graz
Graz
Austria

Massimo Filippi MD
Head, Neuroimaging Research Unit
Department of Neuroscience
San Raffaele Institute
Milan
Italy

Jill S Fischer PhD

Consultant, Neuropsychological &
Health Outcomes Research
Chicago IL
USA

Elizabeth Fisher PhD

Department of Biomedical Engineering
Whitaker Biomedical Imaging Laboratory
Lerner Research Institute
Cleveland Clinic Foundation
Cleveland OH
USA

Corey C Ford MD PhD

Medical Director
Clinical and MR Research Center and Multiple Sclerosis Specialty Clinic
Albuquerque NM
USA

Robert J Fox MD
Associate Staff
Mellen Center for Multiple Sclerosis Treatment and Research
Cleveland Clinic Foundation
Cleveland OH
USA

Melissa Frumin MD
Instructor in Psychiatry
Harvard Medical School and Neuropsychiatrist
Brigham Behavioral Neurology Group
Brigham and Women’s Hospital
Boston MA
USA

Ralf Gold MD
Department of Neurology
Julius-Maximilians-Universität
Würzburg
Germany

Jorge A Gonzalez-Martinez MD
Section of Stereotactic and Functional
Neurosurgery
Department of Neurosurgery
Cleveland Clinic Foundation
Cleveland OH
USA
 Donald E Goodkin MD
Director, Medical Affairs
Amgen Corporation
Seattle WA
USA

Andrew D Goodman MD
Department of Neurology
University of Rochester School of Medicine and Dentistry
Rochester NY
USA

Hans-Peter Hartung MD
Professor and Chairman
Department of Neurology
Karl-Franzens-Universität Graz
Graz
Austria

Stephen L Hauser MD
Professor and Chairman
Department of Neurology
University of California at San Francisco, School of Medicine
San Francisco
USA

Otto R Hommes MD
Chairman
European Charcot Foundation for MS Research
Nijmegen
The Netherlands

Ludwig Kappos
Outpatient Clinic Neurology-Neurosurgery
University Clinics/Kantonsspital
Basel
Switzerland

Mark Keegan MD FRCP(C)

Department of Neurology
Mayo Clinic and Foundation
Rochester MN
USA

Samia J Khoury MD
Associate Professor of Neurology
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