Axiom Clinical Research of Florida - Neurology Research, Tampa, FL

Clinical Trials

Axiom Clinical Research of Florida's ongoing and successfully completed clinical trials listing.

Stephen M. Sergay, MB BCh (MD)
Susan J. Steen, M.D.
Mark C. Cascione, M.D.
Robert G. Wilson, D.O.
Sunil S. Reddy, M.D.

1. A Double-Blind, Parallel, Placebo Controlled, Multiple Dose, 6 Month Study assessing the safety and Efficacy of daily Subcutaneous Injections of recombinant human Ciliate Neurotropic Factor (rhCNTF) in Patients with Amyotrophic Lateral Sclerosis (ALS)

Syntex-Synergen
Protocol #604b
1993—1995

2. Rh CNTF for the Treatment of Amyotrophic Lateral Sclerosis.

Syntex-Synergen
Protocol #606
1993—1995

3. A Double Blind, Placebo controlled, Parallel Group Study to Evaluate Two Dose Levels (10 mg vs 20 mg) of Intranasal Sumatriptan in the Acute Treatment of a Migraine Attack

Glaxo Pharmaceuticals
Protocol #S2B-340
1993—1995

4. A Randomized, Double Blind, Placebo Controlled Study to Evaluate Headache Pain Relief with Sumatriptan Nasal Spray (4 mg, 10 mg, & 20 mg) Across Three Migraine Attacks

Glaxo Pharmaceuticals
Protocol #S2B-342
1996—1997

5. Clinical Experience & Use of Sabril in Patients with Partial Seizures

Marion Merrell Dow Pharmaceuticals
Protocol #VGPR0098
1998—1999

6. Clinical Evaluation of Extended Release Oral Physostigmine in the Treatment of Patients with Dementia of the Alzheimer’s Type

Forest Laboratories
Protocol #1028
1998—1999

7. A Double Blind, Randomized, Placebo Controlled Study to Determine the Effectiveness and Safety of Migramist J (Dihydroergotamine Mesylate Nasal Spray) 2 mg for the Acute Treatment of Migraine Headache With or Without Aura in Migraineur Families

Sandoz Pharmaceuticals
Protocol #DHE-454
1998—1999

8. A Trial of recombinant Methionyl Human Brain Derived Neurotrophic Factor (r- metHuBDNF) Given by Daily Subcutaneous Injection to Patients with Amyotrophic Lateral Sclerosis (ALS)
Amgen-Regeneron Partners
Protocol #930121
1996—1998

9. Compassionate Use of Felbamate in Patients with Epilepsy

Tampa General Hospital
Protocol #242C
1993—1995

10. A Protocol to Provide Lamictal (Lamotrigine) for the Treatment of Serious or Life Threatening Epilepsy

Tampa General Hospital
Protocol #26
1993—1995

11. An Active Treatment Safety Study of Recominant Methionyl Human Brain Derived Neurotrophic Factor (r-methuBDNF) Given by Daily Subcutaneous Injection to Patients with Amyotrophic Lateral Sclerosis

Amgen-Regeneron Partners
Protocol #96011
1998—2000

12. A Double-Blind Randomized, Placebo-Controlled, Multicenter Phase III Study of the
Safety and Efficacy of Intravenous Activase7 Alteplase, Recombinant (Recombinant
Tissue Plasminogen Activator, rt-PA) within 3-5 Hours of Onset of Acute Ischemic Stroke

Genetech, Inc
Protocol A0276g
1997—1999

13. An Open-Label, Multicenter Clinical Trial Evaluating the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients with Alzheimer’s Disease.

Eisai America, Inc
Protocol E2020-A001-313
1998—2000

14. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Impact of Sumatriptan injection on Workplace Productivity Loss Due to Migraine.

Glaxo Wellcome, Inc.
Protocol SUMA4015
2000—2001

15. A Phase 2/3 Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Two Doses of Intravenous Aptiganel Hydrochloride versus Placebo in Patients with an Acute Ischemic Stroke.

Boehringer Ingelheim Pharmaceuticals, Inc.
Protocol 534.11
2000—2001

16. An Open, Randomized, Multicenter Study to Assess the Efficacy and Safety of 1.25 mg q d and 10 mg qd Zydis Selegiline in the Control of Symptoms of Parkinson’s Disease in Patients Stabilized on a Regimen Including Selegiline

Scherer DDS/Harris Clinical Research
Protocol Z/SEL/95/008
1999—2001

17. An Open, Multicenter Parallel Group Continuation Study of Assess the Safety of 1.25 mg q d and 10 mg q d Zydis Selegiline in the Control of Symptoms of Parkinson’s Disease in Patients Stabilized on a Regimen Including Selegiline

Scherer DDS/Harris Clinical Research
Protocol Z/SEL/95/008 Extension
2000—2002

18. A Multicenter, Double-Blind, Randomized Comparison of Zolmitriptan and Sumatriptan in the Acute Treatment of Multiple Migraine Headaches

Zeneca
Protocol 311C90
1998—2000

19. A Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of a Second Sumatriptan Succinate Tablet (25 or 50 mg) in the Acute Treatment of Migraine

Glaxo Wellcome, Inc
Protocol SUMA4014
1999—2001

20. A Treatment Protocol Using Myotrophin (human mecasermin [recombinant DNA origin]) Injection in Patients with Amyotrophic Lateral Sclerosis.

Cephalon, Inc
Protocol C0151a/500/AL/US/(version 1,3)
1999—2001

21. A 26-week Prospective, Multicenter, Open Label, Randomized, Study to Compare Metrifonate and Standard Care. Patients with Dementia of Alzheimer’s Type of Mild to Moderate Severity Will Be Assigned to One of Two Treatment Arms (Metrifonate or Standard care; 4:1 Randomization).

Bayer Pharmaceutical
M.I.N.T. Bay a 9826
2000—2002

22. A Randomized, Double-Blind, Parallel Group Study to Compare the Safety of Efficacy of Zydis Selegiline 1.25 to 2.5 mg q d with Placebo as an Adjunct in the Management of Parkinsonian Patients Being Treated With Levodopa Who Exhibit Deterioration in the Quality of Their Response to This Therapy.

Scherer DDS/MDS Harris
Protocol #Z/SEL/97/026
2000—2002

23. Clinical Experience and use of Sabril (Vigabatrin) in Patients with Partial Seizures

Hoechst Marion Roussel, Inc.
Protocol Number VGPR0098 Clinical Phase IIIb
2000—2002

24. A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Randomized Stratified, Parallel-Group Trial of Rufinamide and Adjunctive Therapy in Children and Adults With Inadequately Controlled Partial Seizures

Novartis (Final Clinical Trial)
Protocol #3310101021
CGP33101 (Rufinamide)
2001—2003

25. A Phase II, Double-Blind, Placebo-Controlled, Safety, Efficacy and Dose Response Trial in Three Intravenous Doses of BMS-204352 in Patients with Acute Stroke.

Bristol-Myers-Squibb
Clinical Protocol #CN123-011
1999—2001

26. Lamictal, In Combination with Newer and Older Antiepileptic Drugs and Monotherapy: A Practical Clinical Assessment of Tolerability and Clinical Effectiveness

Glaxo-Wellcome
Protocol LM40091
1993—1995

27. A Prospective, Randomized, Double-Blind, Active-Controlled, Flexible Dose, Parallel-Group, Multicenter Study to Evaluate the Safety Tolerability and Efficacy of Iloperidone Compared with Risperidone (both 0.5 to 4.0 mg/d given bid) in Treating Psychotic and Behavioral Symptoms in Institutionalized Elderly Patients with Dementia.

Novartis
Protocol 3007
2002—2004

28. A Double-Blind, Placebo Controlled Study of Depakote in the Treatment of Behavioral Agitation in Elderly Patients with Dementia

Abbott Laboratories
Protocol M99-082
2001—2003

29. A Multicenter, Randomized, Double-Blind, Placebo Controlled Flexible Dose Study of Aripiprazole in the Treatment of Institutionalized Patients with Psychosis Associated with Dementia Of the Alzheimer’s Type

Bristol-Myers Squibb (BMS) and
Otsuka America Pharmaceutical (OAPI)
Protocol CN138-005
2001—2003

30. ECLIPSE, Exploring Compliance, Packaging, and Safety A Compliance, Packaging and Safety Assessment of Two Packaging, Formats and Dosing Regimens of GABITRIL (tiagabine hydrochloride) in Subjects with Partial-Onset Seizures.

Abbott Laboratories
Protocol M00-190
2001—2003

31. Open-Label, Multicenter, Randomized Trial to Evaluated the Development of Components of Polycystic Ovary Syndrome (PCOS) in Female Subjects with Newly Diagnosed Epilepsy Initiating anti-Epileptic Drug Treatment on either Lamotrigine or Valproate Monotherapy

Glaxo Wellcome, INC
Protocol LAM30007
2003—2004

32. The Betaseron Experience Satisfaction Trial (BEST) in Educated Multiple Sclerosis Patients.
Berlex Pharmaceuticals
Protocol BEST Trial
2003—2008

33. Efficacy and Safety of a Flexible Dose of Risperidone Versus Placebo in the Treatment of Psychosis of Alzheimer’s Disease

Janssen Research Foundation
Protocol RIS-USA-232
2002—2004

34. A Randomized, Open-Label, Parallel-Groups, Outpatient Study of Examine the Long-Term Safety and Tolerability of Rizatriptan 5 mg po for the Acute Treatment of Migraine in Adolescents.
Merck & CO
Protocol 061-00
2002—2004

35. A Randomized, Multi-Center, Parallel-Group, Open-Label Study Comparing the Tolerability of Rebif Injection With and Without the Use of Rebiject Mini in Relapsing Remitting MS Patients.

Serono, Inc.
Protocol 22982
2002—2004

36. A Single-Dose, Double Blind, Placebo-Controlled, Randomized, Parallel-Design, Oral-Dose (1.2 mg, 0.8 mg, 0.4 mg, and 0.2 mg) Response Study of PG-118415 in the Treatment of Acute Migraine Headaches With and Without Aura.

Proctor & Gamble
Protocol 2001038
2002—2004

37. A Multi-Center, Randomized, Open-Label Comparison of the Effect of ZOMIG-ZMT and Usual Migraine Care on Work Loss, Productivity, and Patient Preference.

AstraZeneca
Protocol 311CUS/0016
2000—2002

38. A Phase II Randomized, Double-Blind, Placebo-Controlled, Escalating Dose Study of the Safety and Tolerability of SUN N4057 Administered For 72 Hours by Continuous Intravenous Infusion in Successive Cohorts of Patients With Acute Ischemic Stroke.

Suntory
Protocol SPI-102
2002—2004

39. A Multi-Center, Phase IV, Randomized, Open-Label Study to Compare the Efficacy of Two Therapies (Acetaminophen and Prednisone) in the Management of Flu-like Symptoms Associated with AVONEX (Interferon-beta-1a) Treatment in Patients with Relapsing Multiple Sclerosis

Biogen
Protocol C-858 (AIMS)
2003—2006

40. A Placebo-Controlled, Dose Titration, Efficacy and Tolerability Study of Neotrofin in Patients with Probable Alzheimer’s Disease.

Neotherapeutics
Protocol 082-2001-001
2003—2004

41. Efficacy and Safety of a Flexible Dose of Risperidone Versus Placebo in the Treatment of Psychosis of Alzheimer’s Disease.

Johnson & Johnson
Protocol RIS-USA-232
2001—2003

42. A Randomized, 30-week, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Dementia Secondary to Cerebrovascular Disease.

Johnson & Johnson
Protocol GAL-INT-26
2001—2003

43. A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Middle of the Night Administration of NBI-34060 in Patients with Primary Insomnia.

Neurocrine Biosciences
Protocol NBI-34060-IR-0209
2002—2003

44. A Multi-Center, Randomized, Double-Blind Placebo-Controlled Flexible Dose Study of Aripiprazole in the Treatment of Institutionalized Patients with Psychosis Associated Dementia of the Alzheimer’s Type.

Bristol Myers Squibb
Protocol CB138-005-036
2001—2003

45. A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study of SNK-860 in Subjects with Diabetic Neuropathy.

Sanwa Kagaku Kankyusho Co., Ltd.
Protocol AR-USA-01
2001—2003

46. A Nine-Month Placebo-Controlled, Phase II, Extension Study of 3 mg, SNK-860 in Subjects with Diabetic Neuropathy.

Sanwa Kagaku Kankyusho Co., Ltd.
Protocol AR-USA-01-EXT
2003—2005

47. BioBank Repository: Collection of Blood, Plasma, and Leukocytes with Matching Demographic, Clinical and Medical History:

SeraCare Life Sciences
Protocol 2467
2003—2004

48. A Phase II Trial To Evaluate The Nutritional Properties Of The Herbal Dietary Supplement QR-334 For Subjects With Excessive Salivary Secretions.

Quigley Pharmaceuticals
Protocol QR-334-001
2003—2004

49. A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS).

Glaxo-Smith-Kline
Protocol 101468/249
2003—2004

50. International, randomized, multicenter, phase III study in patients with relapsing-remitting multiple sclerosis comparing over a treatment period of 104 weeks: Double-blinded the safety, tolerability, and efficacy of Betaseron/Betaferon 250 mg (8 MIU) and Betaseron/Betaferon 500 mg (16 MIU), both given subcutaneously every other day; Rater-blinded the safety, tolerability, and efficacy of Betaseron/Betaferon s.c. every other day with Copaxone 20 mg s.c. once daily.

Berlex Laboratories
Protocol No. 306440 (BEYOND)
2003—2006

51. DNA/RNA/Serum Banking in Subjects with Late Onset Alzheimer’s Disease.

PrecisionMed
Protocol 1007
2003—2004

52. DNA/RNA/Serum Banking in Subjects with Early Onset Alzheimer’s Disease.

PrecisionMed
Protocol 1010
2003—2004

53. A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Elderly Subjects with Chronic Insomnia”

Takeda
Protocol No. 01-02-TL-375-022
2003—2004

54. A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Subjects with Chronic Insomnia”

Takeda
Protocol No. 01-02-TL-375-025
2003—2004

55. A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose CAMPATHÒ (MABCAMPATHÒ) and High-Dose RebifÒ in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis.

Ilex Pharmaceuticals
Protocol No. CAMMS223
2004—2009

56. A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Fixed Dose
Response Study Comparing the Efficacy and Safety of Sumanirole versus Placebo in Patients with Early Parkinson’s Disease.

Pharmacia
Protocol DA2APD-0075-031
2002—2004

57. A randomized, rater-blinded, multi-center, parallel-group study comparing the efficacy and safety of Betaseron® 250mg subcutaneously every other day with Avonex® 30mg intramuscularly once per week in relapsing-remitting multiple sclerosis patients previously treated with Avonex®.

Berlex Laboratories
Protocol No. 307245
2003—2006

58. Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance

Sanofi-Synthelabo Research, USA
Protocol EFC4505 (CHARISMA)
2004—2006

59. A multicenter, double-blind, randomized comparison of the efficacy and safety of quetiapine fumarate (Seroquel) and placebo in the treatment of agitation associated with dementia.

Astra Zeneca
Protocol. 5077US/0046 STAR Trial
2004—2005

60. A Multicenter, randomized, placebo-controlled, double-blind, parallel-group trial to evaluate early efficacy and tolerability of Zolmitriptan (Zomig) Nasal Spray in the acute treatment of adult subjects with migraine.

AstraZeneca
Protocol 311CUS/0022
2002—2004

61. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Comparison of the Effect of ONO-2506 Intravenous Infusion on the Amelioration of Neurological Damage and Improvement in Stroke Assessment Scale Scores in Subjects with Acute Ischemic Stroke".

ONO Pharmaceuticals
Protocol 2506/INT0104
2003—2005

62. A multicenter, double-blind, randomized study to evaluate the safety and efficacy of lamotrigine 200mg/day, 300mg/day, and 400mg/day compared with placebo in subjects with painful diabetic neuropathy.

Glaxo-SmithKline
Protocol NPP30005
2001—2003

63. A Phase-III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Assess
the Efficacy and Safety of a Modified Release Formulation of NBI-35060 in Adult Primary
Insomnia Patient with Sleep Maintenance Difficulties.

PPD Development
Protocol NBI-34060-MR-0404
2003—2004

64. A 5-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of [s,s] –
Reboxetine in Patients with Postherpetic Neuralgia (PNN), who are Gabapentin
Treatment Failures.

Pfizer
Protocol A6061001
2004—2005

65. A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-controlled,
Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in
Adults with Primary Progressive Multiple Sclerosis.

Genentech, Inc.
Protocol U2786g
2004—2009

66. A Multi-Center, Double-Blind, Randomized, Parallel-Group Evaluation of Lamictal
Extended-Release Adjunctive Therapy in Subjects with Partial Seizures.

Glaxo-Smith-Kline
Protocol LAM100034
2004—2005

67. A Double-Blind, Placebo-Controlled, Parallel-Group Study, with an Open-Label
Extension Phase, to Assess the Efficacy, Tolerability & Safety of Oral Frovatriptan in the
Prevention of Menstrually-Related Migraine (MRM) Headaches in a “Difficult to Treat”
Population.
Vernalis Development, Ltd.
Protocol VML-251-3MRM02
2005—2006

68. A 12-Week, Double-Blind, Placebo-Controlled, Twice Daily Dosing Study to Assess the
Efficacy and Safety of Ropinirole in Patients Suffering From Restless Leg Syndrome
(RLS) Requiring Extended Treatment Coverage.

Glaxo-Smith-Kline
Protocol 100013
2004—2005

69. A Phase III Study of the Safety and Efficacy of Alzheimer in Patients with the Mild-to-
Moderate Alzheimer’s Disease.

Neurochem, Inc.
Protocol CL-758007
2004—2008

70. Phase-III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effect
of Daily Treatment with MPC-7869 on Measures of Cognitive and Global Function in
Subjects with Mild to Moderate Dementia of the Alzheimer’s Type.

Myriad Pharmaceuticals, Inc.
Protocol MPC-7869-04-005.02
2004—2008

71. A Double-Blind, Phase II, Safety and Efficacy Evaluation of ONO-2506POU in Patients
with Mild to Moderate Alzheimer’s Disease.

ONO Pharm. USA, Inc.
Protocol ONO-2506POU010
2004—2009

72. An Assessment of Behavioral Changes Associated with Lamotrigine & Levetiracetam in
Patients with Epilepsy.

Glaxo-Smith-Kline
Protocol LAM40124
2003—2004

73. A Phase IV, 2-Year, Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole versus Ropinirole in Early Parkinson’s Disease.
Boehringer Ingelheim Pharmaceuticals, Inc.
Protocol 248.538
2005—2010

74. A Phase IV, 12-Week, Multicenter, Open Lable Study to Evaluate the Effectiveness and Safety of Donepezil Hydrochloride (Aricept) in Hispanic Patients with Mild to Moderate Alzheimer’s Disease.

Eisai/Pfizer
Protocol
2005—2006

75. A Phase IV, Effectiveness and Safety of Frovatriptan for the Management (Acute Treatment) of Menstrual Migraines

Endo Pharmaceuticals
Protocol EN3266-401
2005—2006

76. A Phase III, Randomized, Controlled Comparison of Nefiracetam with Placebo in the Treatment of Patients with Post-Stroke Apathy.

Hamilton Pharmaceuticals, Inc.
Protocol HPI-001-01
2005—2006

77. A Phase III, 4-Week, Randomized, Double Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting from Ropinirole Immediate Release (IR) to Ropinirole Extended Release (XR) Formulation in Patients with Restless Leg Syndrome (RLS).

GlaxoSmithKline
Protocol ROX104805
2005—2007

78. A Phase III, 52-Week, Open Label Study to Assess the Long Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Leg Syndrome (RLS).

GlaxoSmithKline
Protocol ROX101468/206
2006—2008

79. Impact of Neutralizing Antibodies on Interferon Responsive Genes Highlights Biomarker Response

Biogen Idec
Protocol 008-05-AVX (INSIGHT)
2006—2009

80. A Multi-Site, Open Clinical Study to Collect Biological Specimens and Phenotypic Data from a Large Cohort of Subjects for Inclusion in a Repository and Use in Genomic (from DNA and RNA), Serologic and Metabolic (from serum) and Proteomic (from protein research studies).

Genomics Collaborative
Protocol C 101-216
2006—2007

81. A Phase III, Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multi-Center, Outpatient Study to Assess the Efficacy and Safety of Doxepin HCl in Elderly Patients with Primary Sleep Maintenance Insomnia.

Somaxon Pharmaceuticals, Inc.
Protocol SP-0509
2006—2006

82. A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients with Restless Leg Syndrome (RLS).

Xenoport, Inc.
Protocol XP-052
2006—2007

83. A Phase II, Randomized, Open Label, Three-Arm Study Comparing Low and High Dose CAMPATH (MABCAMPATH) and High Dose Rebif in Patients with Early, Active Relapsing-Remitting Multiple Sclerosis.

Genzyme Corporation
Protocol: CAMMS223-A6
2004—2008

84. A Randomized, Double-Blind Study Comparing the Safety and Efficacy of the Lidocaine Patch 5% in Patients with Pain from Carpal Tunnel Syndrome.

Endo Pharmaceuticals
Protocol EN3272-301
2006—2007

85. Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere: ESCAPE Migraine Trial.

St. Jude Medical, Inc.
Protocol IDE #G050112
2006—PRESENT

86. A Study of Combination Product (sumatriptan succinate and naproxen sodium) in Migraine Subjects who Report Poor Response or Intolerance to Eletriptan.

Glaxo-Smith-Kline
Protocol TRX106571
2006—2007

87. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of MEM 1003 in Patients with Mild to Moderate Alzheimer’s Disease.

Memory Pharmaceuticals Corporation
Protocol MEM 1003-004
2006—2007

88. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of MK-0859 in Patients with Primary Hypercholesterolemia or Mixed Hyperlipidemia.

Merck & Company
Protocol MK-0859-003
2006—2007

89. A Randomized, Double-Blind, Placebo-Controlled, Dose Titration Study to Assess the Safety, Tolerability and Efficacy of C105 in Persons with Multiple Sclerosis with Cognitive Impairment.

Cognition Pharmaceuticals, Inc.
Protocol 22029
2006—2008

90. Open Label Study of the Effect of Daily Treatment with MPC-7869 in Subjects with Dementia of the Alzheimer’s Type.

Myriad Pharmaceuticals, Inc.
ProtocolMPC-7869-05-009
2006—2010

91. Phase III Multinational, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Daily Treatment with MPC-7869 on Measures of Cognition, Activities of Daily Living and Global Function in Subjects with Mild Dementia of the Alzheimer’s Type.

Myriad Pharmaceuticals, Inc.
Protocol MPC-786905-010
2006—2010

92. An Open Label Extension of the Phase III Study CL-758007 with Alzheimer in Patients with Alzheimer’s Disease
Neurochem, Inc.
Protocol CL-758017
2006—2010

93. A 24-Month, Double-Blind, Randomized, Multicenter, Placebo-Controlled Parallel Group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily versus Placebo in Patients with Relapsing-Remitting Multiple Sclerosis.

Novartis Pharmaceuticals Corporation
Protocol CFTY720D-2309
2006—2011
94. A 12-Month, Double-Blind, Randomized, Multicenter, Active Controlled, Parallel Group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily versus Interferon B-1a (Avonex) Administered I.M. Once Weekly in Patients with Relapsing-Remitting Multiple Sclerosis with Optional Extension Phase.
Novartis Pharmaceuticals Corporation
Protocol CFTY720D-2302
2006—2011

95. A Phase-II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Efficacy Study of Add-On Cladribine Tablet Therapy with Rebif New Formulation in MS Subjects with Active Disease

Serono, Inc
Protocol 26593
2007—PRESENT

96. A Randomized, Multicenter, Two-Arm, Open Label, 12-Week Phase III-B Study to Evaluate the Tolerability of Rebif (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-Naive Subjects with Relapsing-Remitting Multiple Sclerosis, Followed by a Single Arm 24-week, Rebif-Only Safety Extension.

Serono, Inc.
Protocol 27133
2009—2010

97. A Randomized, Controlled, Open Label, Parallel Group Study to Evaluate the Effect of Regularly Scheduled Neutralizing, Antibody Testing on Treatment Patterns versus Usual Care in High Dose Interferon Treated Subjects.

Teva Neuroscience, Inc.
Protocol Nabs PM028
2006—2009

98. A Randomized, Double-Blind, Placebo-Controlled Dose Response Study to Assess the Efficacy, Safety and Pharmacokinetics of XP13512 in Patients with Restless Legs Syndrome.
XenoPort, Inc.
Protocol XP081
2007—2008

99. A Phase-II, Open Label, Efficacy and Safety Study in Patients with Restless Legs Syndrome (RLS).
XenoPort, Inc.
Protocol XP-052
2007—2009

100. A Phase-III, Randomized, Double-Blind, Safety and Efficacy of Lidocaine Patch 5% in Patients with Carpal Tunnel Syndrome.

ENDO Pharmaceuticals
Protocol EN 3272-301
2006—2007

101. Open Label Extension Safety and Efficacy Study in Patients with Restless Leg Syndrome.
Xenoport, Inc.
Protocol XP-055
2007—2009

102. A Phase-III-B, International, Multicenter, Open Label Relapsing-Remitting Multiple Sclerosis Clinical Trial.
Bayer, Inc.
Protocol 309363
2004—2008

103. An Open Label, Randomized, Multicenter, Parallel Group Study in Patients with Probable Alzheimer’s Disease.

Novartis Pharmaceuticals
Protocol CENA 713 D US 38
2007—2008

104. A Randomized, Double-Blind, Parallel Group Study in Adult Patients with Chronic Insomnia.

Takeda Global Research & Development Center, Inc.
Protocol TAK 01-05-TL-375-069
2007--2007

105. A Phase III, Randomized, Rater and Dose Blinded Study Comparing Two Annual Cycles of Intravenous Low and High Dose Alemguzumab to Three Times weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed on Therapy

Genzyme Corporation
Protocol Number: CAMMS32400507
2007--PRESENT

106. A Phase III Randomized, Rater Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Treatment Naïve Patients with Relapsing-Remitting Multiple Sclerosis (CARE-MS I)

Genzyme Corporation
Protocol Number: CAMMS 323
2007--PRESENT

107. A Phase III Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN 115727) in Patients with Mild to Moderate Alzheimer’s Disease Who Are Apolipoprotein E e4 Non Carriers

Elan Pharmaceuticals
Protocol Number: ELN05727-301
2008--PRESENT

108. A Phase III Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN 115717) in Patients with Mild to Moderate Alzheimer’s Disease Who Are Apolioprotein E e4 Carriers

Elan Pharmaceuticals
Protocol Number: ELN05727-302
2008--PRESENT

109. A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial of PD 0200390 in Adults with Primary Insomnia

Pfizer, Inc.
Protocol Number: A4251037
2007—2010

110. A Randomized, Double Blind, Placebo Controlled Trial of (S,S)-Reboxetine in Patients with Chronic Painful Diabetic Peripheral Neuropathy

Pfizer, Inc.
Protocol Number: A6061037
2007—2008

111. A Phase II A, Multi-Center, Randomized, Double Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of T-817AMa in Patients with Mild to Moderate Alzheimer’s Disease

Toyama Pharmaceuticals
Protocol Number: AA4437420
2008—PRESENT

112. A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase III Study of MAP0004 in Adult Migraineurs for a Single Migraine Followed by Open Label Extensions to 26/52 Weeks

MAP Pharmaceuticals
Protocol Number: MAP0004-CL-P301
2008—PRESENT

113. A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 1.25 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients with Primary Progressive Multiple Sclerosis

Novartis Pharmaceuticals, Inc.
Protocol Number: CFTY720D 2306
2009—PRESENT

114. Effect of LY450139, a y-Secretase Inhibitor, on the Progression of Alzheimer’s Disease as Compared with Placebo

Eli Lilly & Company
Protocol Number: H6L-MC-LFBC
2008—PRESENT

115. Effect f LY2062430, an Anti-Amyloid Beta Monoclonal Antibody, on the Progression of Alzheimer’s Disease as Compared with Placebo

Eli Lilly & Company
Protocol Number: H8A-MC-LZAM
2009—PRESENT

116. A Phase II, Double-Blind, Randomized, Multi-Center, Adaptive Dose-Ranging, Placebo-Controlled, Parallel-Group Study Evaluating Safety, Tolerability and Efficacy on MRI Lesion Parameters and Determining the Dose Response Curve of BAF312 Given Orally Once Daily in Patients with Relapsing-Remitting Multiple Sclerosis

Novartis Pharmaceuticals, Inc.
Protocol Number: CBAF312A2201
2009—2011

117. JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering
Treatment with Tysabri

Biogen/ Idec
Protocol Number: STRATIFY 2
2010—PRESENT

118. A Multi-Center, Double Blind, Parallel-Group Placebo Controlled Study of the Efficacy and
Safety of Teriflunomide in Patients with Relapsing Multiple Sclerosis who are Treated with
Interferon Beta
Sanofi Aventis
Protocol Number: EFC6058
2011—PRESENT

119. A 6-Month, Randomized, Active-Comparator, Open-label, Multi-Center Study to Evaluate Patient
Outcomes, Safety and Tolerability of Fingolimod 0.5 mg/day in Patients with Relapsing Forms of
Multiple Sclerosis who are Candidates for MS Therapy Change from Previous Disease-Modifying
Therapy
Novartis Pharmaceuticals
Protocol Number: CFTY720DUS01
2010—PRESENT

120. A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy
of 2 doses of Oral Dalfampridine Extended Release Tablets (5 mg and 10mg twice daily) in
Patients with Multiple Sclerosis

Acorda
Protocol Number: DER401
2011—PRESENT

121. A Randomized, Double-Blind, Double-Dummy Parallel-Group Study to Evaluate the Efficacy
and Safety of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with
Relapsing Multiple Sclerosis

F. Hoffmann-La Roche LTD
Protocol Number: WA21092B
2011—PRESENT

122. A Phase III, Multi-Center, Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study
to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple
Sclerosis
F. Hoffmann-La Roche LTD
Protocol Number: WA25046
2011—PRESENT

123. A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients with Mild to Moderate Alzheimer’s Disease

Genentech, Inc.
Protocol # ABE4869g
2011-PRESENT

124. A Ph III Extension, Multicenter, Double Blind, Long Term Safety and Tolerability Treatment Tiral of Bapineuzumab (AAB-001, ELN115727) in Subjects with Alzheimer’s Disease Who Participated in Study ELN115727-301 or in Study ELN115727-302

Elan Pharmaceuticals
Protocol # ELN115727-351
2010—PRESENT

125. A Phase II, 24 Mnth, Multi Center, Randomized, Double Blind, Placebo Controlled, Parallel Group Amyloid Imaging Positron Emission Tomography (PET) and Safety Study of ACC-001 and QS 21 Adjuvant in Subjects with Mild to Moderate Alzheimer’s Disease

Janssen Alzheimer Immunotherapy
Protocol # ACC-001-ALZ-2001
2011—PRESENT

126. A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study of the Effect on Cognitive Performance, Safety and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/day for 24 Weeks in Patients with Mild to Moderate Alzheimer’s Disease on Stable Donepezil Therapy

Sanofi-Aventis
Protocol # DRI10734
2011—PRESENT

127. An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

Genzyme Corporation
Protocol # CAMMS03409
2010—PRESENT

128. Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid Beta Antibody in Patients with Alzheimer’s Disease: An Open Label Extension for All Patients Completing Studies LZAM or LZAN

Eli Lilly & Company
Protocol # H8A-MC-LZAO
2011—PRESENT

129. Assessment of LY451395 for Neuropsychiatry Symptoms of Aggression and Agitation in Alzheimer’s Disease

Eli Lilly & Company
Protocol # H6N-MC-LEAQ
2010—2011

UPDATED: July, 2011

[ back to top ]