Clinical Trial Recruitment in Central Nervous System
Disorders - Highest Number of Patients were Recruited
for Clinical Trials in Schizophrenia
Reference Code: GBIHC119MR Publication Date: September 2011
The Highest Number of Trials Were Conducted in Schizophrenia, in Terms of Trials
Conducted for CNS from 2000-2009
The highest number of The number of clinical trials for central nervous system diseases has increased for the past few
clinical trials for central years. The major indications which have been discussed in this report are selected on the basis of
nervous system disorders patient population and the pipeline molecules for that particular indication. On the basis of these
was conducted for two factors, the five major indications chosen were Alzheimer’s disease, Parkinson’s disease,
schizophrenia for the Epilepsy, Schizophrenia and Depression. These five major indications have the highest number of
period 2000-2009 pipeline molecules, and the patient population has a high unmet need for treatment.
GBI Research has analyzed all the clinical trials which started in the period 2000-2009, including
completed, interventional and industry sponsored.
Clinical Trial Recruitment in CNS, Global, Total Number of Clinical Trials in Major
Indications, 2000-2009
160
140 137
120
Total Number of CNS Trials
100
80 82
80 74
71
66 65
60 54 54
47
39
40 36
24
20
9 10
0
Alzheimer's Disease Parkinson's Disease Epilepsy Schizophrenia Depression
Phase I Phase II Phase III
Source: GBI Research, ClinicalTrials.gov
The highest number of clinical trials for central nervous system disorders was conducted for
schizophrenia for the period 2000-2009. The highest proportion of trials in schizophrenia was
conducted in Phase III. The number of clinical trials in Phase II was greater as compared to Phase
III in Alzheimer’s disease trials, whereas for Parkinson’s disease Phase I trials were very few as
compared to Phase II and III trials.
Clinical Trial Recruitment in Central Nervous System GBIHC119MR /Published SEP 2011
Disorders - Highest Number of Patients were
Recruited for Clinical Trials in Schizophrenia Page 1
© GBI Research. This is a licensed product and is not to be photocopied
The Average Number of Patients Recruited per Trial was Highest for Alzheimer’s Disease
from 2000-2009
The average number of patients recruited per trial depends on the protocol specifications and the
phase of the trial. The number of patients required for a particular trial to justify an intervention is
based on the phase of the trial. The highest number of patients was enrolled in Phase III, followed
by Phase II and Phase I of clinical trials.
Clinical Trial Recruitment in CNS, Global, Average Number of Patients Recruited per Trial
by Stage of Development, 2000-2009
700
601
600
Average Number of Patients per Trial by Phase
500
415
400
339 333
300 281
200 179 176
154
121 122
100 87
41 38 47 46
0
Alzheimer's Disease Parkinson's Disease Epilepsy Schizophrenia Depression
Phase I Phase II Phase III
Source: GBI Research, ClinicalTrials.gov
GBI Research found that the number of patients recruited per trial is highest for Phase III trials of
Alzheimer’s disease. The total number of patients recruited in Phase III Alzheimer’s trials was 601,
which was the highest among all trials conducted in major CNS indications from 2000-2009.
CNS Attracted the Highest Number of Clinical Trials After Oncology for the Period 2005-2010
CNS attracted 7,751 trials Pharmaceutical companies conduct clinical trials based on their therapeutic expertise. Not all
from 2005–2010, which pharmaceutical companies conduct trials in all the therapy areas. It is also based on the incidence
was the highest among of a disease in the particular geographic area. The number of clinical trials for a particular indication
the non-oncology group, is higher in the countries which have high prevalence and incidence of those diseases.
as compared to clinical
CNS attracted 7,751 trials from 2005-2010, which was the highest among the non-oncology group,
trials for cardiovascular,
as compared to clinical trials for cardiovascular, infectious, respiratory and other diseases. The high
infectious, respiratory and
number of trials indicated that CNS is a therapy area that is greatly focused on by the
other diseases
pharmaceutical companies. There are many pipeline molecules, along with large patient
populations for indications such as Alzheimer’s disease, Parkinson’s disease, Epilepsy,
Schizophrenia and Depression.
Clinical Trial Recruitment in Central Nervous System GBIHC119MR /Published SEP 2011
Disorders - Highest Number of Patients were
Recruited for Clinical Trials in Schizophrenia Page 2
© GBI Research. This is a licensed product and is not to be photocopied
1 Table of Contents
1 Table of Contents ........................................................................................................................ 3
1.1 List of Tables..................................................................................................................... 6
1.2 List of Figures ................................................................................................................... 9
2 Clinical Trial Recruitment in Central Nervous System Disorders - Introduction ......................... 12
2.1 GBI Research Report Guidance ..................................................................................... 13
3 Clinical Trials Overview ............................................................................................................. 14
3.1 Clinical Trials Share by Therapeutic Area ....................................................................... 14
3.2 Clinical Trials by Pharmaceutical Companies, 2005-2010 .............................................. 21
3.3 Clinical Trials and Patient Recruitment in CNS ............................................................... 22
4 Clinical Trials and Patient Recruitment for Alzheimer’s Disease ............................................... 24
4.1 Introduction ..................................................................................................................... 24
4.2 Clinical Trials for Alzheimer’s Disease ............................................................................ 25
4.2.1 Number of Clinical Trials by Stage of Development ................................................ 25
4.2.2 Number of Clinical Trials by Sponsor ...................................................................... 26
4.2.3 Number of Clinical Trials by Geography .................................................................. 27
4.2.4 Number of Clinical Trials by Year ............................................................................ 28
4.3 Prevalence Population for Alzheimer’s disease (2010-2017) .......................................... 29
4.3.1 Brazil ....................................................................................................................... 29
4.3.2 India......................................................................................................................... 30
4.3.3 China ....................................................................................................................... 31
4.4 Patient Recruitment for Alzheimer’s Disease .................................................................. 32
4.4.1 Number of Patients Recruited by Stage of Development ........................................ 32
4.4.2 Number of Patients Recruited by Sponsor .............................................................. 33
4.4.3 Number of Patients Recruited by Geography .......................................................... 34
4.4.4 Number of Patients Recruited Per Year .................................................................. 35
4.5 Average Number of Patients Recruited Per Trial ............................................................ 36
4.5.1 Average Number of Patients Recruited Per Trial by Stage of Development............ 36
4.5.2 Average Number of Patients Recruited Per Trial Per Year...................................... 37
5 Clinical Trials and Patient Recruitment for Parkinson’s Disease ............................................... 38
5.1 Introduction ..................................................................................................................... 38
5.2 Clinical Trials for Parkinson’s Disease ............................................................................ 39
5.2.1 Number of Clinical Trials by Stage of Development ................................................ 39
5.2.2 Number of Clinical Trials by Sponsor ...................................................................... 40
5.2.3 Number of Clinical Trials by Geography .................................................................. 41
5.2.4 Number of Clinical Trials by Year ............................................................................ 42
5.3 Prevalence Population for Parkinson’s disease (2010-2017).......................................... 43
5.3.1 Brazil ....................................................................................................................... 43
5.3.2 India......................................................................................................................... 44
5.3.3 China ....................................................................................................................... 45
5.4 Patient Recruitment for Parkinson’s Disease .................................................................. 46
5.4.1 Number of Patients Recruited by Stage of Development ........................................ 46
5.4.2 Number of Patients Recruited by Sponsor .............................................................. 47
5.4.3 Number of Patients Recruited by Geography .......................................................... 48
5.4.4 Number of Patients Recruited Per Year .................................................................. 49
5.5 Average Number of Patients Recruited Per Trial ............................................................ 50
5.5.1 Average Number of Patients Recruited Per Trial by Stage of Development............ 50
5.5.2 Average Number of Patients Reruited per Trial per Year ........................................ 51
6 Clinical Trials and Patient Recruitment for Epilepsy .................................................................. 52
6.1 Introduction ..................................................................................................................... 52
6.2 Clinical Trials for Epilepsy ............................................................................................... 53
6.2.1 Number of Clinical Trials by Stage of Development ................................................ 53
6.2.2 Number of Clinical Trials by Sponsor ...................................................................... 54
6.2.3 Number of Clinical Trials by Geography .................................................................. 55
Clinical Trial Recruitment in Central Nervous System GBIHC119MR /Published SEP 2011
Disorders - Highest Number of Patients were
Recruited for Clinical Trials in Schizophrenia Page 3
© GBI Research. This is a licensed product and is not to be photocopied
6.2.4 Number of Clinical Trials by Year ............................................................................ 56
6.3 Prevalence Population for Epilepsy (2010-2017) ............................................................ 57
6.3.1 Brazil ....................................................................................................................... 57
6.3.2 India......................................................................................................................... 58
6.3.3 China ....................................................................................................................... 59
6.4 Patient Recruitment for Epilepsy ..................................................................................... 60
6.4.1 Number of Patients Recruited by Stage of Development ........................................ 60
6.4.2 Number of Patients Recruited by Sponsor .............................................................. 61
6.4.3 Number of Patients Recruited by Geography .......................................................... 62
6.4.4 Number of Patients Recruited Per Year .................................................................. 63
6.5 Average Number of Patients Recruited Per Trial ............................................................ 64
6.5.1 Average Number of Patients Recruited Per Trial by Stage of Development............ 64
6.5.2 Average Number of Patients Recruited Per Trial Per Year...................................... 65
7 Clinical Trials and Patient Recruitment for Schizophrenia ......................................................... 66
7.1 Introduction ..................................................................................................................... 66
7.2 Clinical Trials for Schizophrenia ...................................................................................... 67
7.2.1 Number of Clinical Trials by Stage of Development ................................................ 67
7.2.2 Number of Clinical Trials by Sponsor ...................................................................... 68
7.2.3 Number of Clinical Trials by Geography .................................................................. 69
7.2.4 Number of Clinical Trials by Year ............................................................................ 70
7.3 Prevalence Population for Schizophrenia (2010-2017) ................................................... 71
7.3.1 Brazil ....................................................................................................................... 71
7.3.2 India......................................................................................................................... 72
7.3.3 China ....................................................................................................................... 73
7.4 Patient Recruitment for Schizophrenia............................................................................ 74
7.4.1 Number of Patients Recruited by Stage of Development ........................................ 74
7.4.2 Number of Patients Recruited by Sponsor .............................................................. 75
7.4.3 Number of Patients Recruited by Geography .......................................................... 76
7.4.4 Number of Patients Recruited Per Year .................................................................. 77
7.5 Average Number of Patients Recruited Per Trial ............................................................ 78
7.5.1 Average Number of Patients Recruited Per Trial by Stage of Development............ 78
7.5.2 Average Number of Patients Recruited Per Trial Per Year...................................... 79
8 Clinical Trials and Patient Recruitment for Depression.............................................................. 80
8.1 Introduction ..................................................................................................................... 80
8.2 Clinical Trials for Depression .......................................................................................... 81
8.2.1 Number of Clinical Trials by Stage of Development ................................................ 81
8.2.2 Number of Clinical Trials by Sponsor ...................................................................... 82
8.2.3 Number of Clinical Trials by Geography .................................................................. 83
8.2.4 Number of Clinical Trials by Year ............................................................................ 84
8.3 Prevalence Population for Depression (2010-2017) ....................................................... 85
8.3.1 Brazil ....................................................................................................................... 85
8.3.2 India......................................................................................................................... 86
8.3.3 China ....................................................................................................................... 87
8.4 Patient Recruitment for Depression ................................................................................ 88
8.4.1 Number of Patients Recruited by Stage of Development ........................................ 88
8.4.2 Number of Patients Recruited by Sponsor .............................................................. 89
8.4.3 Number of Patients Recruited by Geography .......................................................... 90
8.4.4 Number of Patients Recruited Per Year .................................................................. 91
8.5 Average Number of Patients Recruited Per Trial ............................................................ 92
8.5.1 Average Number of Patients Recruited per Trial by Stage of Development ............ 92
8.5.2 Average Number of Patients Recruited per Trial per Year ...................................... 93
9 Clinical Trials Recruitment in Central Nervous System: Appendix............................................. 94
9.1 Market Definitions ........................................................................................................... 94
9.2 Abbreviations .................................................................................................................. 94
9.3 Research Methodology ................................................................................................... 94
Clinical Trial Recruitment in Central Nervous System GBIHC119MR /Published SEP 2011
Disorders - Highest Number of Patients were
Recruited for Clinical Trials in Schizophrenia Page 4
© GBI Research. This is a licensed product and is not to be photocopied
9.3.1 Coverage ................................................................................................................. 94
9.3.2 Secondary Research ............................................................................................... 95
9.3.3 Primary Research .................................................................................................... 95
9.3.4 Expert Panel Validation ........................................................................................... 95
9.3.5 Section-wise methodology ....................................................................................... 95
9.4 Contact Us ...................................................................................................................... 97
9.5 Disclaimer ....................................................................................................................... 97
9.6 Sources ........................................................................................................................... 97
Clinical Trial Recruitment in Central Nervous System GBIHC119MR /Published SEP 2011
Disorders - Highest Number of Patients were
Recruited for Clinical Trials in Schizophrenia Page 5
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1.1 List of Tables
Table 1: Clinical Trial Recruitment in CNS, Global, Ongoing Trials by Therapeutic Area, 2005-
2010 ............................................................................................................................... 14
Table2: Clinical Trial Recruitment in CNS, Asia, Ongoing Trials by Therapeutic Area, 2005-2010
....................................................................................................................................... 15
Table3: Clinical Trial Recruitment in CNS, Europe, Ongoing Trials by Therapeutic Area, 2005-
2010 ............................................................................................................................... 16
Table4: Clinical Trial Recruitment in CNS, Middle East, Ongoing Trials by Therapeutic Area,
2005-2010 ...................................................................................................................... 17
Table5: Clinical Trial Recruitment in CNS, South and Central America, Ongoing Trials by
Therapeutic Area, 2005-2010 ........................................................................................ 18
Table6: Clinical Trial Recruitment in CNS, North America, Ongoing Trials by Therapeutic Area,
2005-2010 ...................................................................................................................... 19
Table7: Clinical Trial Recruitment in CNS, Rest of World, Ongoing Trials by Therapeutic Area,
2005-2010 ...................................................................................................................... 20
Table8: Clinical Trial Recruitment in CNS, Global, Clinical Trials by Pharmaceutical Companies,
2005-2010 ...................................................................................................................... 21
Table9: Clinical Trial Recruitment in CNS, Global, Clinical Trials in Major Indications, 2000-2009
....................................................................................................................................... 22
Table10: Clinical Trial Recruitment in CNS, Global, Total Number of Patients Recruited for Major
Indications, 2000-2009 ................................................................................................... 23
Table 11: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Total Number of Clinical Trials
by Phase, 2000-2009 ..................................................................................................... 25
Table 12: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Total Number of Clinical Trials
by Sponsor, 2000-2009 .................................................................................................. 26
Table 13: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Total Number of Clinical Trials
by Geography, (%), 2000-2009 ...................................................................................... 27
Table 14: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Total Number of Clinical Trials
per Year, 2000-2009 ...................................................................................................... 28
Table 15: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Prevalence Population, Brazil,
(million) 2010-2017 ........................................................................................................ 29
Table 16: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Prevalence Population, India,
(Million) 2010-2017 ........................................................................................................ 30
Table 17: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Prevalence Population, China,
(Million) 2010-2017 ........................................................................................................ 31
Table 18: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Total Number of Patients
Recruited by Phase, 2000-2009 ..................................................................................... 32
Table 19: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Total Number of Patients
Recruited by Sponsor, 2000-2009.................................................................................. 33
Table 20: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Total Number of Patients
Recruited by Geography, (%), 2000-2009...................................................................... 34
Table 21: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Total Number of Patients
Recruited per Year, 2000-2009 ...................................................................................... 35
Table 22: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Average Number of Patients
Recruited per Trial by Stage of Development, 2000-2009 ............................................. 36
Table 23: Clinical Trial Recruitment in CNS, Alzheimer’s Disease, Average Number of Patients
Recruited per Trial per Year, 2000-2009 ........................................................................ 37
Table 24: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Total Number of Clinical Trials
by Phase, 2000-2009 ..................................................................................................... 39
Table 25: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Total Number of Clinical Trials
by Sponsor, 2000-2009 .................................................................................................. 40
Table 26: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Total Number of Clinical Trials
by Geography (%), 2000-2009 ....................................................................................... 41
Table 27: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Total Number of Clinical Trials
per Year, 2000-2009 ...................................................................................................... 42
Table 28: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Prevalence Population, Brazil,
(Million), 2010-2017 ....................................................................................................... 43
Table 29: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Prevalence Population, India,
(Million), 2010-2017 ....................................................................................................... 44
Table 30: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Prevalence Population, China,
(Million), 2010-2017 ....................................................................................................... 45
Clinical Trial Recruitment in Central Nervous System GBIHC119MR /Published SEP 2011
Disorders - Highest Number of Patients were
Recruited for Clinical Trials in Schizophrenia Page 6
© GBI Research. This is a licensed product and is not to be photocopied
Table 31: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Total Number of Patients
Recruited by Phase, 2000-2009 ..................................................................................... 46
Table 32: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Total Number of Patients
Recruited by Major Sponsors, 2000-2009 ...................................................................... 47
Table 33: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Total Number of Patients
Recruited by Geography (%), 2000-2009....................................................................... 48
Table 34: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Total Number of Patients
Recruited per Year, 2000-2009 ...................................................................................... 49
Table 35: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Average Number of Patients
Recruited by Stage of Development, 2000-2009............................................................ 50
Table 36: Clinical Trial Recruitment in CNS, Parkinson’s Disease, Average Number of Patients
Recruited per Trial per Year, 2000-2009 ........................................................................ 51
Table 37: Clinical Trial Recruitment in CNS, Epilepsy, Total Number of Clinical Trials by Phase,
2000-2009 ...................................................................................................................... 53
Table 38: Clinical Trial Recruitment in CNS, Epilepsy, Total Number of Clinical Trials by Major
Sponsors, 2000-2009 ..................................................................................................... 54
Table 39: Clinical Trial Recruitment in CNS, Epilepsy, Total Number of Clinical Trials by
Geography (%), 2000-2009 ............................................................................................ 55
Table 40: Clinical Trial Recruitment in CNS, Epilepsy, Total Number of Clinical Trials per Year,
2000-2009 ...................................................................................................................... 56
Table 41: Clinical Trial Recruitment in CNS, Epilepsy, Prevalence Population, Brazil, (Million),
2010-2017 ...................................................................................................................... 57
Table 42: Clinical Trial Recruitment in CNS, Epilepsy, Prevalence Population, India, (Million),
2010-2017 ...................................................................................................................... 58
Table 43: Clinical Trial Recruitment in CNS, Epilepsy, Prevalence Population, China, (Million),
2010-2017 ...................................................................................................................... 59
Table 44: Clinical Trial Recruitment in CNS, Epilepsy, Total Number of Patients Recruited by
Phase, 2000-2009 .......................................................................................................... 60
Table 45: Clinical Trial Recruitment in CNS, Epilepsy, Total Number of Patients Recruited by Major
Sponsors, 2000-2009 ..................................................................................................... 61
Table 46: Clinical Trial Recruitment in CNS, Epilepsy, Total Number of Patients Recruited by
Geography (%), 2000-2009 ............................................................................................ 62