Cerebral Palsy Global Clinical Trials Review, H1, 2014 Reference Code: GDHC2156CTIDB Publication Date: MAY 2014 Page 1
Table of Contents Table of Contents... 2 List of Tables... 4 List of Figures... 5 Introduction... 6 Cerebral Palsy... 6 Report Guidance... 6 Clinical Trials by Region... 7 Clinical Trials and Average Enrollment by Country... 8 Top Five Countries Contributing to Clinical Trials in Asia-Pacific... 10 Top Five Countries Contributing to Clinical Trials in Europe... 11 Top Countries Contributing to Clinical Trials in North America... 12 Top Countries Contributing to Clinical Trials in Middle East and Africa... 13 Top Countries Contributing to Clinical Trials in Central and South America... 14 Clinical Trials by G7 Countries: Proportion of Cerebral Palsy to Central Nervous System Clinical Trials... 15 Clinical Trials by Phase in G7 Countries... 16 Clinical Trials in G7 Countries by Trial Status... 17 Clinical Trials by E7 Countries: Proportion of Cerebral Palsy to Central Nervous System Clinical Trials... 18 Clinical Trials by Phase in E7 Countries... 19 Clinical Trials in E7 Countries by Trial Status... 20 Clinical Trials by Phase... 21 In Progress Trials by Phase... 22 Clinical Trials by Trial Status... 23 Clinical Trials by End Point Status... 24 Unaccomplished Trials of Cerebral Palsy... 25 Subjects Recruited Over a Period of Time... 28 Clinical Trials by Sponsor Type... 29 Prominent Sponsors... 30 Top Companies Participating in Cerebral Palsy Therapeutics Clinical Trials... 31 Prominent Drugs... 32 Clinical Trial Profiles... 33 Clinical Trial Overview of Top Companies... 33 Allergan, Inc.... 33 Clinical Trial Overview of Allergan, Inc.... 33 Ipsen S.A.... 34 Clinical Trial Overview of Ipsen S.A.... 34 Merz Pharma GmbH & Co. KgaA... 35 Clinical Trial Overview of Merz Pharma GmbH & Co. KgaA... 35 Medtronic, Inc.... 36 Clinical Trial Overview of Medtronic, Inc.... 36 Acorda Therapeutics, Inc.... 37 Clinical Trial Overview of Acorda Therapeutics, Inc.... 37 GlaxoSmithKline plc... 38 Clinical Trial Overview of GlaxoSmithKline plc... 38 Daiichi Sankyo Company, Limited... 39 Clinical Trial Overview of Daiichi Sankyo Company, Limited... 39 Page 2
Clinical Trial Overview of Top Institutes / Government... 40 Eunice Kennedy Shriver National Institute of Child Health and Human Development... 40 Clinical Trial Overview of Eunice Kennedy Shriver National Institute of Child Health and Human Development... 40 The Sheba Medical Center... 41 Clinical Trial Overview of The Sheba Medical Center... 41 Shriners Hospitals for Children... 42 Clinical Trial Overview of Shriners Hospitals for Children... 42 VU University Medical Center... 43 Clinical Trial Overview of VU University Medical Center... 43 Bundang Cha Hospital... 44 Clinical Trial Overview of Bundang Cha Hospital... 44 National Institute of Neurological Disorders and Stroke... 45 Clinical Trial Overview of National Institute of Neurological Disorders and Stroke... 45 Chang Gung Memorial Foundation... 46 Clinical Trial Overview of Chang Gung Memorial Foundation... 46 Stanford University... 47 Clinical Trial Overview of Stanford University... 47 Hvidovre University Hospital... 48 Clinical Trial Overview of Hvidovre University Hospital... 48 Shaare Zedek Medical Center... 49 Clinical Trial Overview of Shaare Zedek Medical Center... 49 Five Key Clinical Profiles... 50 Appendix... 76 Abbreviations... 76 Definitions... 76 Research Methodology... 77 Secondary Research... 77 About GlobalData... 78 Disclaimer... 78 Source... 78 Page 3
List of Tables Cerebral Palsy Therapeutics, Global, Clinical Trials by Region, 2014*... 7 Cerebral Palsy Therapeutics, Global, Clinical Trials and Average Enrollment by Top Countries, 2014*... 8 Cerebral Palsy Therapeutics, Global, Clinical Trials In Progress by Top Countries, 2014*... 9 Cerebral Palsy Therapeutics Clinical Trials, Asia-Pacific, Top Five Countries, 2014*... 10 Cerebral Palsy Therapeutics Clinical Trials, Europe, Top Five Countries, 2014*... 11 Cerebral Palsy Therapeutics Clinical Trials, North America, Top Countries, 2014*... 12 Cerebral Palsy Therapeutics Clinical Trials, Middle East and Africa, Top Countries, 2014*... 13 Cerebral Palsy Therapeutics Clinical Trials, Central and South America, Top Countries, 2014*... 14 Proportion of Cerebral Palsy to Central Nervous System Clinical Trials, G7 Countries (%), 2014*... 15 Cerebral Palsy Therapeutics, G7 Countries, Clinical Trials by Phase, 2014*... 16 Cerebral Palsy Therapeutics, G7 Countries, Clinical Trials by Trial Status, 2014*... 17 Proportion of Cerebral Palsy to Central Nervous System Clinical Trials, E7 Countries (%), 2014*... 18 Cerebral Palsy Therapeutics, E7 Countries, Clinical Trials by Phase, 2014*... 19 Cerebral Palsy Therapeutics, E7 Countries, Clinical Trials by Trial Status, 2014*... 20 Cerebral Palsy Therapeutics, Global, Clinical Trials by Phase, 2014*... 21 Cerebral Palsy Therapeutics, Global, Clinical Trials In Progress by Phase 2014*... 22 Cerebral Palsy Therapeutics, Global, Clinical Trials by Trial Status, 2014*... 23 Cerebral Palsy Therapeutics Clinical Trials, Global, by End Point Status, 2014*... 24 Cerebral Palsy Therapeutics, Global, Suspended Clinical Trials, 2014*... 25 Cerebral Palsy Therapeutics, Global, Withdrawn Clinical Trials, 2014*... 26 Cerebral Palsy Therapeutics, Global, Terminated Clinical Trials, 2014*... 27 Cerebral Palsy Therapeutics Clinical Trials, Global, Average Enrollment Target Trends, 2009-2013... 28 Cerebral Palsy Therapeutics Market, Global, Clinical Trials by Sponsor Type, 2014*... 29 Cerebral Palsy Therapeutics Clinical Trials, Global, Key Sponsors, 2014*... 30 Cerebral Palsy Therapeutics Clinical Trials, Global, Top Companies by Phase, 2014*... 31 Cerebral Palsy Therapeutics Clinical Trials, Global, Ongoing Clinical Trials by Prominent Drugs, 2014*... 32 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Allergan, Inc., 2014*... 33 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Ipsen S.A., 2014*... 34 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Merz Pharma GmbH & Co. KgaA, 2014*... 35 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Medtronic, Inc., 2014*... 36 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Acorda Therapeutics, Inc., 2014*... 37 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by GlaxoSmithKline plc, 2014*... 38 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Daiichi Sankyo Company, Limited, 2014*... 39 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Eunice Kennedy Shriver National Institute of Child Health and Human Development, 2014*... 40 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by The Sheba Medical Center, 2014*... 41 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Shriners Hospitals for Children, 2014*... 42 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by VU University Medical Center, 2014*... 43 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Bundang Cha Hospital, 2014*... 44 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by National Institute of Neurological Disorders and Stroke, 2014*... 45 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Chang Gung Memorial Foundation, 2014*... 46 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Stanford University, 2014*... 47 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Hvidovre University Hospital, 2014*... 48 Cerebral Palsy Therapeutics Clinical Trials Market, Global, Clinical Trials by Shaare Zedek Medical Center, 2014*... 49 Page 4
List of Figures Cerebral Palsy Therapeutics, Global, Clinical Trials by Region (%), 2014*... 7 Cerebral Palsy Therapeutics, Global, Clinical Trials and Average Enrollment by Top Countries, 2014*... 8 Cerebral Palsy Therapeutics, Global, Clinical Trials In Progress by Top Countries, 2014*... 9 Cerebral Palsy Therapeutics Clinical Trials, Asia-Pacific, Top Five Countries (%), 2014*... 10 Cerebral Palsy Therapeutics Clinical Trials, Europe, Top Five Countries (%), 2014*... 11 Cerebral Palsy Therapeutics Clinical Trials, North America, Top Countries (%), 2014*... 12 Cerebral Palsy Therapeutics Clinical Trials, Middle East and Africa, Top Countries (%), 2014*... 13 Cerebral Palsy Therapeutics Clinical Trials, Central and South America, Top Countries (%), 2014*... 14 Proportion of Cerebral Palsy to Central Nervous System Clinical Trials, G7 Countries (%), 2014*... 15 Cerebral Palsy Therapeutics, G7 Countries, Clinical Trials by Phase, 2014*... 16 Cerebral Palsy Therapeutics, G7 Countries, Clinical Trials by Trial Status, 2014*... 17 Proportion of Cerebral Palsy to Central Nervous System Clinical Trials, E7 Countries (%), 2014*... 18 Cerebral Palsy Therapeutics, E7 Countries, Clinical Trials by Phase, 2014*... 19 Cerebral Palsy Therapeutics, E7 Countries, Clinical Trials by Trial Status, 2014*... 20 Cerebral Palsy Therapeutics, Global, Clinical Trials by Phase (%), 2014*... 21 Cerebral Palsy Therapeutics, Global, Clinical Trials In Progress by Phase, 2014*... 22 Cerebral Palsy Therapeutics, Global, Clinical Trials by Trial Status, 2014*... 23 Cerebral Palsy Therapeutics Clinical Trials, Global, by End Point Status, 2014*... 24 Cerebral Palsy Therapeutics Clinical Trials, Global, Average Enrollment Target Trends, 2009-2013... 28 Cerebral Palsy Therapeutics Market, Global, Clinical Trials by Sponsor Type (%), 2014*... 29 Cerebral Palsy Therapeutics Clinical Trials, Global, Key Sponsors, 2014*... 30 Cerebral Palsy Therapeutics Clinical Trials, Global, Top Companies by Phase, 2014*... 31 Cerebral Palsy Therapeutics Clinical Trials, Global, Ongoing Clinical Trials by Prominent Drugs, 2014*... 32 GlobalData Methodology... 77 Page 5
Introduction Cerebral Palsy Cerebral palsy is defined as a group of disorders that involve brain and nervous system functions like thinking, seeing, learning, movement and hearing. Cerebral palsy is caused by abnormalities or injuries of the brain. There are several types of cerebral palsy. They are mixed cerebral palsy, dyskinetic cerebral palsy, hypotonic cerebral palsy, spastic cerebral palsy, ataxic cerebral palsy and so on. Complications of cerebral palsy include osteoporosis, pneumonia, scoliosis, social stigma, bowel obstruction, poor nutrition, reduced intellect, seizures, reduced communication skills, hip dislocation, joint contractures, injuries from falls and arthritis in the hip joint. Symptoms of cerebral palsy include urinary incontinence, increased drooling, joint contracture, tremors, muscle weakness, loss of coordination, dysarthria, seizures, decreased intelligence, pain, constipation, swallowing problem, vomiting, and irregular breathing and so on. Tests done to diagnose cerebral palsy include vision testing, blood tests, CT scan of the head, MRI of the head, hearing screen and electroencephalogram. Treatment for cerebral palsy depends on person s symptoms and the need to avoid complications. Treatment for cerebral palsy includes physical therapy, orthopedic help, medications, occupational therapy and surgery. Medications for cerebral palsy include anticonvulsants, muscle relaxants and spasticity improving drugs. Report Guidance Cerebral Palsy Global Clinical Trials Review, H1, 2014 outlines clinical trials in Cerebral Palsy. The prominent features of this report are - 1. Comprehensive data related to Cerebral Palsy clinical trials by region, country, phase, and recruitment status 2. Clinical trials conducted by key Companies and Institutes. The selection of the sponsors is based on the total number of Cerebral Palsy clinical trials conducted 3. Prominent drugs are provided based on number of ongoing clinical trials 4. The trials compiled in this report are from clinical trial registries, conferences, journals etc Page 6
Clinical Trials by Region Cerebral Palsy Therapeutics, Global, Clinical Trials by Region (%), 2014* Source: GlobalData s Pharma etrack Clinical Trials Database (*)Trials are taken for a time period of 1982-2014 2014 trials are taken as of May 2014 Cerebral Palsy Therapeutics, Global, Clinical Trials by Region, 2014* North America Europe Asia-Pacific Middle East and Africa South and Central America Total World Zones Source: GlobalData s Pharma etrack Clinical Trials Database (*)Trials are taken for a time period of 1982-2014 2014 trials are taken as of May 2014 Number of Clinical Trials Page 7
Cerebral Palsy Therapeutics, Global, Clinical Trials In Progress by Top Countries, 2014* 2014 Source: GlobalData s Pharma etrack Clinical Trials Database (*)Trials are taken for a time period of 1982-2014 2014 trials are taken as of May 2014 Cerebral Palsy Therapeutics, Global, Clinical Trials In Progress by Top Countries, 2014* Country Name Number of Clinical Trials (In Progress) United States Canada South Korea India Netherlands Poland United Kingdom Australia Germany China Total Source: GlobalData s Pharma etrack Clinical Trials Database (*)Trials are taken for a time period of 1982-2014 2014 trials are taken as of May Page 9
Top Five Countries Contributing to Clinical Trials in Asia-Pacific Cerebral Palsy Therapeutics Clinical Trials, Asia-Pacific, Top Five Countries (%), 2014* Source: GlobalData s Pharma etrack Clinical Trials Database (*)Trials are taken for a time period of 1982-2014 2014 trials are taken as of May 2014 Cerebral Palsy Therapeutics Clinical Trials, Asia-Pacific, Top Five Countries, 2014* South Korea Australia India China Taiwan Total Country Name Source: GlobalData s Pharma etrack Clinical Trials Database (*)Trials are taken for a time period of 1982-2014 2014 trials are taken as of May 2014 Number of Clinical Trials Page 10
Appendix Abbreviations BRIC: Brazil, Russia, India and China Definitions PHASE I TRIALS: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. PHASE II TRIALS: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. PHASE III TRIALS: Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and were intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling. PHASE IV TRIALS: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use. TRIAL STATUS: Indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include: Trial in Progress: This is inclusive of; Planned: participants were not yet being recruited or enrolled Recruiting: participants were currently being recruited and enrolled Enrolling by invitation: participants were being (or will be) selected from a predetermined population Active, not recruiting: study is ongoing (i.e., patients were being treated or examined), but enrollment has completed Completed: the study has concluded normally; participants were no longer being examined or treated (i.e., last patient's last visit has occurred) Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants were no longer being examined or treated Withdrawn: study halted prematurely, prior to enrollment of first participant SUBJECTS RECRUITED: The number of patients so enrolled for the trial in concern, to be analyzed. UNACCOMPLISHED TRIALS: The category comprising of the terminated, withdrawn and suspended trials. Page 76
Research Methodology GlobalData dedicated Research and Analysis Teams consists of experienced professionals with a pedigree in marketing, market research and consulting in the pharmaceutical industry with advanced statistical expertise. GlobalData adheres to the Codes of Practice of the Market Research Society (www.mrs.org.uk) and the Society of Competitive Intelligence Professionals (www.scip.org). All GlobalData databases were continuously updated and revised. The following research methodology is followed for all databases and reports. GlobalData Methodology Source: GlobalData Secondary Research Data extraction from Pharma etrack Data Validation Data Analysis Self QC Quality check by QC Lead Submission of the Report The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market. The secondary research sources that were typically referred to include, but were not limited to: Company websites, annual reports, financial reports, broker reports, investor presentations and SEC Filings; Industry trade journals, scientific journals and other technical literature; Internal and external proprietary databases; Relevant patent and regulatory databases; National government documents, statistical databases and market reports; Procedure registries; and News articles, press releases and web-casts specific to the companies operating in the market. Page 77
About GlobalData We hope that the data and analysis in this brief will help you make informed and imaginative business decisions. If you have further requirements, GlobalData consulting team may be able to help you. GlobalData offers Tailor made analytical and advisory services to drive your key strategic decisions. Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. Source http://clinicaltrials.gov/ http://www.pharmaetrack.com/ http://www.medpedia.com/ https://www.goldbamboo.com/pictures-t1192.html http://www.clinicalconnection.com/ http://www.trialscentral.org/ http://www.thefreelibrary.com/ http://dailymed.nlm.nih.gov/dailymed/about.cfm http://www.nextbio.com/b/nextbio.nb http://www.controlled-trials.com/isrctn/search.html http://www.anzctr.org.au/trialsearch.aspx https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=search&action=input&language=e Page 78