CLINICAL RESEARCH

CLINICAL TRIALS

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

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  • Stephen M. Sergay, MB BCh (MD)
  • Susan J. Steen, M.D.
  • Mark C. Cascione, M.D.
  • Sunil S. Reddy, M.D.
  • Sherley R. Valdez Arroyo, 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 g (8 MIU) and Betaseron/Betaferon 500 g (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 CAMPATH (MABCAMPATH) and High-Dose Rebif 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® 250g subcutaneously every other day with Avonex® 30g 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—2013

  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--2014

  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--2014

  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--2013

  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--2013

  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—2013

  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—2014

  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—2014

  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—2013

  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—2013

  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—2013

  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—2014

  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—2013

  120. An Open Label, Multicenter Study Evaluating Patient Injection Satisfaction with Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection Utilizing Autoject 2 Devices

    TEVA NeuroScience
    Protocol Number: PM034
    2010 -- 2011

  121. 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—2013

  122. 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

  123. 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—2013

  124. 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
    2011-2014

  125. 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—2012

  126. 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—2014

  127. 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—2013

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

    Genzyme Corporation
    Protocol # CAMMS03409
    2010—PRESENT

  129. 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

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

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

  131. A Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects with Relapsing Remitting Multiple Sclerosis to Assess the Efficacy, Safety, and Tolerability of Glatiramer Acetate 20 mg/0.5 mL New Formulation Administered Daily by Subcutaneous Injection

    TEVA NeuroScience
    Protocol Number: GA-MS-302
    2012 -- 2012

  132. A Phase IIa Safety and Tolerability Study to Investigate the Effecton Sleep of (3) Doses of AZD5213 and Placebo in Patients with Mild Alzheimer’s Disease and Mild Cognitive Impairment During (4) Weeks of Treatment, Designed as a Randomized Double Blind Multi-Center Parallel Group Placebo Controlled Study

    Astra Zeneca Corporation
    Protocol # D3030C00005
    2012—2013

  133. A Randomized Double Blinded Placebo Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects with Prodromal or Mild Alzheimer’s Disease (Phase 1b)

    Biogen Idec MA, Inc.
    Protocol # 221AD103
    2012—PRESENT

  134. Study RXP114025: A Randomized Double Blind Placebo Controlled Fixed Dose Parallel Group Study to Compare the Efficacy, Tolerability, and Safety of (3) Doses of Gabapentin Enacarbil (GSK 1838262) with Placebo in the Treatment of Subjects with Moderate to Severe Restless Legs Syndrome (RLS) (Ph IV)

    GlaxoSmithKline
    Protocol # RXP114025
    2012—2014

  135. A Phase II Multicenter Randomized Double Blind Parallel Group Placebo Controlled Study to Investigate the Efficacy and Safety of RO4602522 Added to the Background Therapy of the Acetylcholinesterase Inhibitors Donepezil or Rivastigmine in Patients with Moderate Severity Alzheimer’s Disease

    F. Hoffman-LaRoche, Ltd.
    Protocol # BP28248
    2012—2015

  136. A Single Arm Open Label Multicenter Study Evaluating the Long Term Safety, Tolerability, and Efficacy of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients with Multiple Sclerosis

    Novartis Pharmaceuticals Corporation
    Protocol # CFTY720D2399
    2012—PRESENT

  137. A 12 Month Randomized Rater and Dose Blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily with Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients with Relapsing Remitting Multiple Sclerosis (Ph III b)

    Novartis Pharmaceuticals Corporation
    Protocol # CFTY720D2312
    2012—PRESENT

  138. A Phase II Double Blind Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of Tovaxin in Subjects with Secondary Progressive Multiple Sclerosis

    Opexa Therapeutics, Inc.
    Protocol # 2012-00
    2012—2014

  139. A Randomized 18 Week Placebo Controlled Double Blind Parallel Group Study of the Safety and Efficacy of PF-05212377 (SAM-760) in Subjects with Mild to Moderate Alzheimer’s Disease with Existing Neuropsychiatric Symptoms on a Stable Daily Dose of Donepezil (Ph IIa)

    Pfizer , Inc.
    Protocol # B2081011-1026
    2012—2014

  140. A Randomized Double Blind Placebo Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects with Spasticity due to Multiple Sclerosis (Ph III)

    XenoPort, Inc.
    Protocol # XP-B-089
    2012—2013

  141. An Open Label 26 Week Study Assessing Arbaclofen Placarbil Safety and Efficacy in Subjects with Spasticity Associated with Multiple Sclerosis (Ph III)

    XenoPort, Inc.
    Protocol # XP-B-091
    2012—2014

  142. A 12 Month, Prospective, Randomized, Active Controlled, Open Label Study to Evaluate the Patient Retention of Fingolimod vs Approved First Line Disease Modifying Therapies in Adults Who Are in Early Stages of Treatment for Relapsing Remitting Multiple Sclerosis (Ph IV)

    Novartis, Inc.
    Protocol # CFTY720DUS09 (PREFER)
    2012—2014T

  143. A 26 Week, Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Effects of Daily Administration of AC-1204 in Participants with Mild to Moderate Alzheimer’s Disease (AD)with an Optional 26 Week Open Label Extension (Ph III)

    Accera, Inc.
    Protocol # AC-12-010
    2013—2014

  144. A Multicenter, Open Label, Single Arm Study of Gastrointestinal Tolerability in Relapsing Remitting Multiple Sclerosis Patients Receiving Oral BG00012 (Dimethyl Fumarate) (Ph IV)

    Biogen Idec, Inc.
    Protocol # 109MS403
    2013—2014

  145. A Placebo Controlled, Double Blind, Parallel Group, Bayesian Adaptive Randomization Design and Dose Regimen Finding Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects with Early Alzheimer’s Disease (Ph II)

    Eisai, Ltd.
    Protocol # BAN2401-G000-201
    2013—2014

  146. A Multicenter, Open Label, Long Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients with Mild to Moderate Alzheimer’s Disease (Ph III)

    Genentech, Inc.
    Protocol # GN28525
    2013—PRESENT

  147. Effect of Passive Immunization on the Progression of Mild Alzheimer’s Disease: Solanezumab (LY2062430) versus Placebo Ph III)

    Eli Lilly, Inc.
    Protocol # H8A-MC-LZAX
    2013 – PRESENT

  148. Randomized Double Blind Placebo Controlled Parallel Group 18 Month Safety and Efficacy Study of Leuco-methylthioninium bis (hydromethanesulfonate) in Subjects with Mild Alzheimer’s Disease (Ph III)

    TauRx Therapeutics, Ltd.
    Protocol # TauRX237-005
    2013 – PRESENT

  149. A Phase 2, Randomized Double Dummy Double Blind Placebo Controlled Study to Assess the Eficacy, Safety, and Tolerability of AVP-923 (dextromethorphan/quinidine) for the Treatment of Symptoms of Agitation in Patients with Alzheimer’s Disease (Ph II)

    Avanir Pharmaceuticals
    Protocol # 12-AVR-131
    2013 – 2014

  150. A Multicenter Randomized Double Blind Parallel Group Placebo Controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients with Secondary Progressive Multiple Sclerosis (Ph III)

    Novartis Pharmaceuticals
    Protocol # CBAF312A2304
    2013 – PRESENT

  151. An Open Label Two Arm Randomized Study to Characterize Flu Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning from Current Interferon Beta Therapies to BIIB017 (Ph IIIb)

    Biogen Idec
    Protocol # 105MS303
    2013 – 2015

  152. A Phase II Randomized Multicenter Double Blind Placebo Controlled Parallel Group Study Comparing HT-0712 with Placebo in Patients with Age-Associated Memory Impairment (AAMI)

    Dart Pharmaceuticals
    Protocol # HT-0712-201
    2013-2014

  153. A Multicenter Open Label Ph IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera (Delayed Release Dimethyl Fumarate) Treatment in Multipe Sclerosis Patients

    Biogen Idec
    Protocol 109MS413 (ADHERE)
    2014 – 2015

  154. A Ph III Multicenter Randomized Double Blind Double Dummy Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relappsing Multiple Sclerosis Patients

    Receptos, Inc.
    Protocol RPC01-301
    2014 -- PRESENT

  155. Impact of the BETACONNECT Auto-Injector on BETASERON Therapy Adherence and Patient Satisfaction

    Bayer HealthCare Pharmaceuticals
    Protocol BETACONNECT
    2016– PRESENT

  156. An Open Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects with Relapsing Remitting Multiple Sclerosis

    Biogen Idec Research Limited
    Protocol 109MS310
    2016 – PRESENT

  157. A Phase III Multicenter Randomized Double Blind Placebo Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzheimer’s Disease

    Biogen Idec Research Limited
    Protocol 221AD302 (EMERGE/CLARITY)
    2016 -- PRESENT

  158. A Long Term Follow Up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study CAMMS03409

    Genzyme / Sanofi Group
    Protocol LPS13649 (TOPAZ)
    2016 – PRESENT

  159. An Open Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Relapsing Remitting Multiple Sclerossis Who Have Had A Suboptimal Response to An Adequate Course of Disease-Modifying Treatment

    Genentech, Inc.
    Protocol MN30035
    2016 – PRESENT

  160. A Phase III Multicenter Randomized Double Blind Placebo Controlled Parallel Group Efficacy and Safety Study of Crenezumab in Patients with Prodromal to Mild Alzheimer’s Disease

    F. Hoffmann-LaRoche Ltd
    Protocol BN29552
    2016 – Present

  161. Imaging Dementia – Evidence for Amyloid Scanning IDEAS) Study: A Coverage with Evidence Development Longitudinal Cohort Study

    American College of Radiology Imaging Network
    Protocol IDEAS
    2016 – Present

  162. A Randomized Double Blind Placebo Controlled Ph II Study Assessing the Safety, Tolerability and Efficacy of Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer’s Disease

    Neurotrope BioScience
    Protocol NTRP101-202
    2016 – Present

  163. A Ph II A Randomized Parallel Group Placebo Controlled Study of 50 mg and 100 mg of SUVN-502 and Placebo in Subjects with Mild to Moderate Alzheimer’s Disease Currently Treated with Donepezil Hydrochloride and Memantine Hydrochloride