Innovative drug development for headache disorders PDF
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Innovative Drug Development for Headache Disorders Frontiers in Headache Research Volume 16 FRONTIERS IN HEADACHE RESEARCH SERIES Published by Lippincott-Raven Volume 1:Migraine and Other Headaches: The Vascular Mechanisms J.Olesen,editor;1991 Volume 2:5-Hydroxytryptamine Mechanisms in Primary Headaches J.Olesen and P.R.Saxena,editors;1992 Volume 3:Tension-Type headache: Classification,Mechanisms and Treatment J.Olesen and J.Schoenen,editors;1993 Volume 4:Headache Classification and Epidemiology J.Olesen,editor;1994 Volume 5:Experimental Headache Models J.Olesen and M.A.Moskowitz,editors;1995 Volume 6:Headache Treatment: Trial Methodology and New Drugs J.Olesen and P.Tfelt-Hansen,editors;1995 Volume 7:Headache Pathogenesis: Monoamines,Neuropeptides,Purines and Nitric Oxide J.Olesen and L.Edvinsson,editors;1997 Volume 8:Genetics ofHeadache Disorders J.Olesen,editors;1998 Published by Oxford University Press Volume 9:Cluster Headache and Related Conditions J.Olesen and P.Goadsby,editors;1999 Volume 10:The Triptans: Novel Drugs for Migraine P.Humphrey,M Ferrari,and J.Olesen,editors;2001 Volume 11:Reducing the Burden ofHeadache J.Olesen,T.J.Steiner,and R.Lipton,editors;2003 Volume 12:Preventive Pharmacotherapy ofHeadache Disorders J.Olesen,S.D.Silberstein,and P.Tfelt-Hansen,editors;2004 Volume 13:The Classification and Diagnosis ofHeadache Disorders J.Olesen,editor;2005 Volume 14:From Basic Pain Mechanisms to Headache J.Olesen and T.S.Jensen,editors;2006 Volume 15:Headache Clinics: Organization,Patients and Treatment R.Jensen,H-C.Diener,and J.Olesen,editors;2007 Volume 16:Innovative Drug Development for Headache Disorders J.Olesen and N.Ramadan,editors;2008 Innovative Drug Development for Headache Disorders Frontiers in Headache Research Volume 16 Edited by Jes Olesen Department of Neurology and Danish Headache Centre, Glostrup Hospital, University of Copenhagen, Denmark Nabih Ramadan Diamond Headache Clinic Chicago, Illinois, USA 1 1 Great Clarendon Street,Oxford OX2 6DP Oxford University Press is a department ofthe University ofOxford. It furthers the University’s objective ofexcellence in research,scholarship, and education by publishing worldwide in Oxford New York Auckland Cape Town Dar es Salaam Hong Kong Karachi Kuala Lumpur Madrid Melbourne Mexico City Nairobi New Delhi Shanghai Taipei Toronto With offices in Argentina Austria Brazil Chile Czech Republic France Greece Guatemala Hungary Italy Japan Poland Portugal Singapore South Korea Switzerland Thailand Turkey Ukraine Vietnam Oxford is a registered trade mark ofOxford University Press in the UK and in certain other countries Published in the United States by Oxford University Press Inc.,New York © Oxford University Press,2008 The moral rights ofthe authors have been asserted Database right Oxford University Press (maker) First published 2008 All rights reserved.No part ofthis publication may be reproduced, stored in a retrieval system,or transmitted,in any form or by any means, without the prior permission in writing ofOxford University Press, or as expressly permitted by law,or under terms agreed with the appropriate reprographics rights organization.Enquiries concerning reproduction outside the scope ofthe above should be sent to the Rights Department, Oxford University Press,at the address above You must not circulate this book in any other binding or cover and you must impose this same condition on any acquirer A catalog record for this title is available from the British Library Data available Library ofCongress Cataloging in Publication Data Data available Typeset by Cepha Imaging Private Ltd.,Bangalore,India Printed in Great Britain on acid-free paper by Biddles Ltd.,King’s Lynn,Norfolk ISBN 978–0–19–955276–4 10 9 8 7 6 5 4 3 2 1 While every effort has been made to ensure that the contents ofthis book are as complete,accurate and up-to-date as possible at the date ofwriting,Oxford University Press is not able to give any guarantee or assurance that such is the case. Readers are urged to take appropriately qualified medical advice in all cases.The information in this book is intended to be useful to the general reader,but should not be used as a means ofself-diagnosis or for the prescription ofmedication. Contents Preface viii Contributors ix Session I Screening models 1 The human γ-aminobutyric acid transporter GAT-2:from cloning to high throughput screening 3 Bolette Christiansen,Trine Kvist,Anders A.Jensen,and Hans Bräuner-Osborne 2 Low throughput preclinical models for headache 17 Peter J.Goadsby 3 Human models:screening models 25 Messoud Ashina Session II Trials methodology 4 Stricter success criteria,qualitative and quantitative end-points:acute versus prevention trials 31 Peer Tfelt-Hansen 5 Health-related quality oflife and similar end-points 43 Carl G.H.Dahlöf 6 Clinically relevant designs and outcome measures for acute migraine trials 57 Michel D.Ferrari and Hille Koppen 7 Effectiveness ofdifferent steroid dosage in Tolosa–Hunt syndrome with different phenotypes:some critical points about the new International Headache Society classification 59 E.Marchioni,S.Colnaghi,M.Versino,A.Pichiecchio, E.Tavazzi,and G.Nappi 8 Discussion summary:Trials methodology 63 Jes Olesen Session III Nitric oxide and spreading depression modulators 9 Inducible nitric oxide synthase and development ofnew migraine treatments 67 Boris A.Chizh vi CONTENTS 10 Mechanisms ofcortical spreading depression as targets for migraine therapy 73 Kevin C.Brennan and Andrew C.Charles 11 Tonabersat 85 Peter R.Blower and Paul C.Sharpe 12 Discussion summary:Nitric oxide and spreading depression modulators 95 Nabih Ramadan Session IV Calcitonin gene-related peptide and 5-hydroxytryptamine modulators 13 Calcitonin gene-related peptide:relevance for migraine 99 Jes Olesen and Inger Jansen-Olesen 14 New 5-hydroxytryptamine-related drug targets 109 Pramod R.Saxena 15 Effect oftwo novel calcitonin gene-related peptide-binding compounds in a closed cranial window rat model 115 Louise Juhl,Lars Edvinsson,Jes Olesen, and Inger Jansen-Olesen 16 Vasoactive intestinal polypeptide is unlikely to be a target for headache and migraine treatment 121 Jakob Møller Hansen,Alexandra Maria Rahmann, Jes Olesen,and Messoud Ashina 17 Discussion summary:Calcitonin gene-related peptide and 5-hydroxytryptamine modulators 129 Rigmor Jensen Session V Ion channel modulators and antiepileptics 18 Migraine:from genes to pathophysiology – transgenic mouse models ofmigraine 133 Arn M.J.M.van den Maagdenberg 19 K channels and migraine 143 ATP Inger Jansen-Olesen and Kenneth Beri Ploug 20 Antiepileptic drugs and migraine 153 Michael A.Rogawski CONTENTS vii 21 Discussion summary:Ion channel modulators and antiepileptics 179 Pramod R.Saxena Session VI Other future targets for headache therapy 22 Innovative drug development for headache disorders:glutamate 185 Kirk W.Johnson,Eric S.Nisenbaum,Michael P.Johnson, Donna K.Dieckman,Amy Clemens-Smith,Edward R.Siuda,Colin P.Dell, Veronique Dehlinger,Kevin J.Hudziak,Sandra A.Filla,Paul L.Ornstein, Nabih M.Ramadan,and David Bleakman 23 The modulation ofTRPV1 channels by cannabinoid 1 receptors 195 Beatriz Fioravanti and Todd W.Vanderah 24 Future targets for headache therapy:prostanoids 205 Christian Waeber 25 Role ofanandamide in the modulation of nitroglycerin-induced hyperalgesia: a study in the rat 219 Cristina Tassorelli,Rosaria Greco,Armando Perrotta, Simona Buscone,Giorgio Sandrini,and Giuseppe Nappi Index 223 Preface Migraine treatment was very much improved with the advent of the triptans in the 1990s.While previous drugs have had efficacy,compounds such as ergotamine,had bothersome side-effects and their overuse could lead to severe complications.The trip- tans were the first class ofdrugs with high receptor specificity and disease specificity.In the early days ofthe triptans,it was widely presumed that migraine was no longer a treat- ment problem.However,it has gradually been recognized that a significant proportion of patients are not responsive to triptans or do not tolerate them.Furthermore,the success criteria in the triptan trials were quite relaxed.With more strict success criteria,particu- larly the sustained pain-free response,one-third ofthe patients or lower respond.It is now clear that,even with effective attack treatment,patients with frequent attacks are not treated well exclusively with acute medications.This is partly because patients are still bothered by the attacks and partly because frequent intake of acute medication may result in medication overuse headache.These problems have led to a renewed interest in preventive migraine drugs.In relation to the other major primary headache disorder, chronic tension-type headache,there has not been much progress.Amitriptyline is still the mainstay oftreatment but recently mirtazapine has also proven to be ofvalue.There is a great need for preventive drugs for chronic tension-type headache. Recent European data have shown that research funding ofthe migraine in Europe is the lowest ofall of12 major brain disorders studied.Research support to other types of headache could not be identified at all.The combined headache field probably receives less than 10% ofthe funding ofepilepsy or movement disorders but costs society four times more.How can therapeutic progress then be expected? The happy message is that despite the gloomy figures on research support,there have been significant advances in migraine research over recent years.As demonstrated in this volume,there are several promising new avenues for the development of future drugs for migraine.The main principles with proof of concept,but not yet in full clinical development,are cortical spreading depression inhibition,nitric oxide synthase inhibition,and calcitonin gene- related peptide receptor antagonism.The present book presents frontline knowledge as far as it is available in the public domain.Hopefully,readers and their patients will find it exciting to learn about all the novel possibilities,and hopefully the impressive research advances in migraine will lead to increased funding,not only of migraine but also of other types ofheadache.Only then can we fully exploit all the academic advances for the benefit ofour patients. Contributors Ashina,Messoud Chizh,Boris A. Danish Headache Center and Department GlaxoSmithKline,Addenbrooke’s ofNeurology,Glostrup Hospital, Centre for Clinical Investigation, University ofCopenhagen, Addenbrooke’s Hospital, Glostrup,Denmark Cambridge,UK Bleakman,David Christiansen,Bolette Lilly Research Laboratories,Lilly Department ofMedical Chemistry, Corporate Center, Faculty ofPharmaceutical Sciences, Indianapolis,USA University ofCopenhagen, Copenhagen,Denmark Blower,Peter R. Minster Pharmaceuticals plc., Clemens-Smith,Amy Audley End Business Centre, Lilly Research Laboratories,Lilly The Old Forge,Saffron Walden, Corporate Center, Essex,UK Indianapolis,USA Bräuner-Osborne,Hans Colnaghi,S. Department ofMedical Chemistry, Laboratory ofOcular Movements, Faculty ofPharmaceutical Sciences, Foundation IRCCS ‘C.Mondino’, University ofCopenhagen, Pavia,Italy Copenhagen,Denmark Dahlöf,Carl G.H. Brennan,Kevin C. Institute ofNeuroscience and Physiology, Headache Research and Treatment Department ofClinical Neuroscience Program,Department ofNeurology, and Rehabilitation, David Geffen School ofMedicine at Sahlgrenska University Hospital, UCLA,Los Angeles,California,USA Göteborg,Sweden Buscone,Simona Dehlinger,Veronique University Centre for the Study of Eli Lilly and Co.Ltd.,Lilly Research Adaptive Disorder and Headache, Centre,Erl Wood Manor, University ofPavia,Italy Windlesham, Surrey,UK Charles,Andrew C. Headache Research and Treatment Dell,Colin P. Program,Department ofNeurology, Eli Lilly and Co.Ltd.,Lilly Research David Geffen School ofMedicine at Centre,Erl Wood Manor, UCLA,Los Angeles,USA Windlesham Surrey,UK
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