CONTRACTS (clinical trials)

All entries for Morsani College of Medicine clinical trials listed below were selected by the USF Health Morsani College of Medicine Office of Research:  

Title:  A Double-Blind, Placebo-Controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating The Efficacy, Safety, And Tolerability Of Cariprazine In A Dose-Reduction Paradigm In The Prevention Of Relapse In Bipolar I Disorder Patients Whose Current Episode Is Manic Or Depressive With Or Without Mixed Features
Phase:  IIIb
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Allergan
Opening date: 6/25/2018

Title:  An Open-Label, Long-Term Safety Study Including a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period of TEV-50717 (deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
Phase:  III
Principal investigator: Murphy, Tanya
Department: Pediatrics
Sponsor: Nuvelution
Opening date: 6/4/2018

Title:  A Prospective, Open-Label, Multicenter Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Therapure PlasmaCap IG in Adults and Children with Primary Immune Deficiency Diseases
Phase:  III
Principal investigator: Leiding, Jennifer
Department: Pediatrics
Sponsor: Therapure
Opening date: 5/17/2018

Title:  A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in  Patients 6 to 17 Years of Age with Episodic Migraine
Phase:  N/A
Principal investigator: Kalidas, Kavita
Department: Neurology
Sponsor: Eli Lilly
Opening date: 5/17/2018 

 Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes Mellitus Phase 3 Alogliptin Pediatric Study
Phase:  III
Principal investigator: Rodriguez, Henry
Department: Diabetes Center
Sponsor: Takeda
Opening date: 5/11/2018

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Phase:  III
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: Corbus Pharmaceuticals
Opening date: 5/9/2018 

Title:  Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts (ECLIPSE)
Phase:  Device
Principal investigator: Matar, Fadi
Department: Cardiology
Sponsor: Cardiovascular Systems
Opening date: 4/27/2018

Title:  A Phase III, randomized, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV-1 infected adults who are virologically suppressed
Phase:  III
Principal investigator: Casanas, Beata
Department: Internal Medicine
Sponsor: GlaxoSmithKline
Opening date: 4/25/2018 

Title:  Development of Population Health Software
Phase:  N/A
Principal investigator: Berlowitz, Michael
Department: Cardiology
Sponsor: Medtronic
Opening date: 4/19/2018

Title:  Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Phase:  II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Amylyx
Opening date: 4/18/2018

Title:  A phase 2, Multicenter, Open-Label Study to Assess PK/PD of SEG101 (crizanlizumab), with or without Hydroxyurea/Hydroxycarbamide, in Adult Sickle Cell Patients with Vaso-Occlusive Crisis
Phase:  II
Principal investigator: Rico, Juan
Department: Pediatrics
Sponsor: Novartis
Opening date: 4/13/2018 

Title:  A Study of EZN-2279 (Polyethylene Glycol Recombinant Adenosine Deaminase [PEG-rADA]) Administered as a Weekly Intramuscular Injection in Patients With Adenosine Deaminase (ADA)-Deficient Combined Immunodeficiency
Phase:  III
Principal investigator: Walter, Jolan
Department: Pediatrics
Sponsor: Leadiant Biosciences
Opening date: 4/4/2018

Title:  A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects with Generalized Myasthenia Gravis
Phase:  II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Ra Pharma
Opening date: 3/28/2018

Title:  A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of BB3 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney
Phase:  III
Principal investigator: Jarmi, Tambi
Department: Internal Medicine
Sponsor: TGH
Opening date: 3/26/2018  

Title:  An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
Phase:  II
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Abbvie
Opening date: 3/16/2018 

Title:  A Prospective Outcome Study on Patients with Profound Combined Immunodeficiency
Phase:  N/A
Principal investigator: Walter, Jolan
Department: Pediatrics
Sponsor: Medical Center University of Freiburg
Opening date: 3/12/201 

Title:  A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Pharma Two B
Opening date: 3/6/2018 

Title:  Open-label, single-arm, multiple-dose safety, titration, and pharmacokinetic study of AFREZZA® in pediatric subjects ages 4 to 17 years with type 1 diabetes mellitus
Phase:  II
Principal investigator: Rodriguez, Henry
Department: Diabetes Center
Sponsor: MannKind Corp.
Opening date: 2/28/2018 

Title:  Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 ER for the Treatment of Pediatric Patients with Attention Deficit/Hyperactivity Disorder (ADHD).
Phase:  II/III
Principal investigator: Fallon, Daniel
Department: Psychiatry
Sponsor: Supernus Pharmaceuticals
Opening date: 2/19/2018 

Title:  Phenotypic, Genotypic, and Functional Characterization of Primary Immune Deficiencies
Phase:  N/A
Principal investigator: Leiding, Jennifer
Department: Pediatrics
Sponsor: Horizon
Opening date: 2/12/2018 

Title:  Assessing Relationships Between Cognitive Function and Brain Atrophy in MS Patients
Phase:  I
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Prime Education, Inc.
Opening date: 1/16/2018 

Title:  A randomized, subject- and investigator-blinded, placebo-controlled, multi-center, multiple dose study to assess the efficacy and safety of CJM112 in patients with inadequately controlled moderate to severe asthma
Phase:  II
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Novartis
Opening date: 1/11/2018

Title:  A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma
Phase:  III
Principal investigator: Seminario-Vidal, Lucia
Department: Dermatology
Sponsor: Eisai
Opening date: 1/3/2018

Title:  TAAA Debranching System comprised of the Thoracic Bifurcation and the Visceral Manifold
Phase:  I
Principal investigator: Shames, Murray
Department: Surgery
Opening date: 12/4/2017

Title:  Multicenter 1 -Year Observational Study of Patients Who Are Initiating Brivaracetam
Phase:  I
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: UCB Biosciences
Opening date: 12/4/2017 

Title:  A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF)
Phase:  III
Principal investigator: Labovitz, Arthur
Department: Cardiology
Sponsor: Boehringer Ingelheim Pharmaceuticals (BIPI)
Opening date: 12/4/2017

Title:  A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two-Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants with Parkinson’s Disease
Phase:  IIa
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Northwestern University
Opening date: 12/4/2017

Title:  A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO)
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: NeuroDerm Ltd.
Opening date: 11/30/2017 

Title:  A Phase 1/2, Open-Label, Adaptive, Dose-Ranging Study to Assess the Safety and Tolerability of SB-525 (recombinant AAV2/6 human Factor 8 Gene Therapy) in Adult Subjects with Severe Hemophilia A
Phase:  I/II
Principal investigator: Visweshwar, Nathan
Department: Internal Medicine
Sponsor: Sangamo Therapeutics
Opening date: 11/30/2017

 Title:  A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose-Optimization Study to Assess the Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects with Tourette Syndrom
Phase:  IIb
Principal investigator: Murphy, Tanya
Department: Pediatrics
Sponsor: Neurocrine Biosciences
Opening date: 11/30/2017

 Title:  Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
Phase:  III
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Aimmune Therapeutics, Inc.
Opening date: 11/30/2017

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease
Phase:  IIa
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Biogen Idec
Opening date: 11/28/2017

Title:  A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the  Efficacy and Safety of FLX-787-ODT for Treatment of  Muscle Cramps in Adult Subjects with Charcot-Marie-Tooth Disease
Phase:  I
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Flex Pharma, Inc.
Opening date: 11/28/2017

Title:  A Phase 3, Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled, Fixed-dose Safety and Efficacy Study of SPD489 Compared with Placebo in Preschool Children Aged 4-5 Years with Attention-deficit/Hyperactivity Disorder
Phase:  III
Principal investigator: Murphy, Tanya
Department: Pediatrics
Sponsor: Shire
Opening date: 11/28/2017

Title:  A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years Diagnosed with Attention-deficit/Hyperactivity Disorder
Phase:  III
Principal investigator: Murphy, Tanya
Department: Pediatrics
Sponsor: Shire
Opening date: 11/28/2017

Title:  Protocol Title  SPIRIT 2: An International Phase 3 Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain
Phase:  III
Principal investigator: Imudia, Anthony
Department: OB/GYN
Sponsor: Myovant Sciences
Opening date: 11/22/2017

Title:  An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids
Phase:  III
Principal investigator: Imudia, Anthony
Department: OB/GYN
Sponsor: Myovant Sciences
Opening date: 11/22/2017 

Title:  Multicenter, Prospectively Defined Observational Registry With Retrospective Data Collection, Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide via Invasive or Noninvasive Ventilator Support at U.S. Centers
Phase:  Observational
Principal investigator: Maheshwari, Akhil
Department: Pediatrics
Sponsor: Mallinckrodt Pharmaceuticals
Opening date: 11/21/2017

Title:  A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of X4P-001 in Patients with Mutations of CXCR4 Associated with a Primary Immunodeficiency (WHIM Syndrome)
Phase:  II/III
Principal investigator: Walter, Jolan
Department: Pediatrics
Sponsor: X4 Pharmaceuticals
Opening date: 11/15/2017

Title:  Evaluation of SPN-812 ER 200 and 400 mg Efficacy and Safety in Children with ADHD – A Double-Blind, Placebo-Controlled, Pivotal Trial
Phase:  III
Principal investigator: Fallon, Daniel
Department: Psychiatry
Sponsor: Supernus Pharmaceuticals
Opening date: 11/3/2017

Title:  Evaluation of SPN-812 ER 400 and 600 mg Efficacy and Safety in Adolescents with ADHD – A Double-Blind, Placebo-Controlled, Pivotal Trial
Phase:  III
Principal investigator: Fallon, Daniel
Department: Psychiatry
Sponsor: Supernus Pharmaceuticals
Opening date: 11/3/2017

Title:  A Phase 3, Randomized, Double-Blind, Study Comparing ABT-494 to Placebo in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
Phase:  III
Principal investigator: Carter, John
Department: Internal Medicine
Sponsor: Abbvie
Opening date: 10/31/2017 

Title:  A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Subjects Assessed to be at Imminent Risk for Suicide
Phase:  III
Principal investigator: Currier, Glenn
Department: Psychiatry
Sponsor: Janssen
Opening date: 10/31/2017

Title:  A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis
Phase:  II
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 10/24/2017 

Title:  A Multicenter, Open-Label, Long-Term Safety Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects who Participated in a Prior AR101 Study
Phase:  I
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Aimmune Therapeutics, Inc.
Opening date: 10/24/2017 

Title:  A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adult Subjects With Friedreich Ataxia
Phase:  II
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Takeda
Opening date: 10/19/2017

Title:  UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)
Phase:  III
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: TG Therapeutics
Opening date: 10/16/2017

 Title:  VOLTAIRE-X: Pharmacokinetics, safety, immunogenicity and efficacy of BI 695501 versus Humira® in patients with moderate to severe chronic plaque psoriasis: a randomized, double-blind, parallel-arm, multiple-dose, active comparator trial.
Phase:  III
Principal investigator: Patel, Nishit
Department: Dermatology
Sponsor: Boehringer Ingelheim Pharmaceuticals (BIPI)
Opening date: 10/13/2017

Title:  A clinical investigation to study the effect of Exufiber Ag+ and other gelling fibre dressings on wound exudate and bioburden in medium to high exuding wound.
Phase:  Device
Principal investigator: Davis, Donald
Department: Surgery
Sponsor: Mölnlycke Health Care
Opening date: 10/12/2017

Title:  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation Study With an Open-Label Phase to Examine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-935 as an Adjunctive Therapy in Subjects With Developmental and/or Epileptic Encephalopathies
Phase:  I
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: Takeda
Opening date: 10/10/2017

Title:  A Phase 2, Open Label Extension Study To Investigate the Long-term Safety and Tolerability of PF-06649751 in Subjects With Motor Fluctuations Due To Parkinson’s Disease
Phase:  II
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Pfizer
Opening date: 10/10/2017

Title:  Effect of MD1003 in progressive multiple sclerosis: a randomized double blind placebo controlled study
Phase:  III
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: MEDDAY Pharmaceuticals
Opening date: 10/6/2017

Title:  A Phase 3, Randomized, Double-Blind, Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) – SELECT – PsA 1
Phase:  III
Principal investigator: Carter, John
Department: Internal Medicine
Sponsor: Abbvie
Opening date: 10/5/2017 

Title:  Parallel-Group, Placebo-Controlled Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque™ Injection 320 mgI/mL) on Renal Function in adults with Chronic Kidney Disease (CKD) Stage III or Stage IV Who Have Undergone Endovascular Aneurysm Repair (EVAR)
Phase:  IV
Principal investigator: Shames, Murray
Department: Surgery
Sponsor: GE Healthcare
Opening date: 10/4/2017

Title:  A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34)Process Administered Concomitantly with M-M-R™ II
Phase:  III
Principal investigator: Soylu, Lana
Department: Pediatrics
Sponsor: Merck
Opening date: 10/4/2017 

Title:  A Phase 3 Study to Compare the Efficacy and Safety of Humacyte’s Human Acellular Vessel with that of an Autologous Arteriovenous Fistula in Subjects with End-Stage Renal Disease
Phase:  III
Principal investigator: Illig, Karl
Department: Surgery
Sponsor: Humacyte, Inc.
Opening date: 10/3/2017

 Title:  An Open-Label, Repeat-Dose Pharmacokinetics Study of NRL-1 in Epilepsy Subjects Under Seizure and Normal Conditions
Phase:  I
Principal investigator: Benbadis, Selim
Department: Neurology
Sponsor: Neurelis
Opening date: 9/21/2017 

Title:  The VALUE Study: VAlidation of a Lower cost aneUploidy scrEen
Phase:  N/A
Principal investigator: Odibo, Anthony
Department: OB/GYN
Sponsor: Women & Infants Hospital of Rhode Island
Opening date: 9/21/2017

Title:  A Phase 2a, Double-Blind, Placebo-Controlled Two-Part Study To Investigate the Safety and Efficacy of Increasing Doses Of DNS-7801 In Parkinson’s Disease (PD) Subjects With Motor Fluctuations
Phase:  IIa
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Dart NeuroScience
Opening date: 9/21/2017

Title:  A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Phase:  II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Cytokinetics, Inc.
Opening date: 9/19/2017

Title:  A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose “Wearing-Off”
Phase:  III
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Biotie Therapies
Opening date: 9/18/2017

 Title:  A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR
Phase:  III
Principal investigator: Patel, Kapil
Department: Internal Medicine
Sponsor: TGH
Opening date: 9/14/2017

Title:  Real‐World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents (RE‐Kinect)
Phase:  Registry
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Neurocrine Biosciences
Opening date: 9/1/2017

Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BMS-986168 in Participants With Progressive Supranuclear Palsy
Phase: IIb
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Bristol-Myers Squibb
Opening date: 8/24/2017

Title:
A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of FLX-787-ODT (orally disintegrating tablet) for Treatment of Muscle Cramps in Adult Subjects With Motor Neuron Disease
Phase: II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Flex Pharma, Inc.
Opening date: 8/24/2017

Title: A Randomized, Crossover, Open-Label, Multiple Dose, Pivotal Pharmacokinetic Bioequivalence Study
Comparing Paliperidone Palmitate Extended-Release IM 156 mg/1 mL (100 mg eq) With Invega Sustenna®
(U.S Product Reference) in Subjects with Schizophrenia or Schizoaffective Disorder
Phase: Bioequivalence with pharmacokinetics endpoints
Principal investigator: Currier, Glenn
Department: Psychiatry
Sponsor: PharmaScience
Opening date: 8/24/2017

Title: A Pilot, Prospective, Randomized, Controlled, Multicenter Technical Feasibility Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
Phase: I
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Cohera Medical
Opening date: 8/22/2017

Title: A Multicenter, International, Open-Label Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson’s Disease
Phase: IIb
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: NeuroDerm Ltd.
Opening date: 8/18/2017

Title: A Multicenter, Randomized, Investigator-and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
Phase: IIa
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: UCB Biosciences
Opening date: 8/17/2017

Title: Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Phase: II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Amylyx
Opening date: 8/16/2017

Title: Safety and Efficacy of Hizentra in Pediatric Hematopoietic Stem Cell Recipients
Phase: N/A
Principal investigator: Sriaroon, Panida
Department: Pediatrics
Sponsor: Carolinas Healthcare
Opening date: 8/15/2017

Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction and Maintenance Treatment For Patients With Moderately to Severely Active Crohn’s Disease
Phase: III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Roche
Opening date: 8/15/2017

Title: An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
Phase: III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Roche
Opening date: 8/15/2017

Title: An Open-Label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in Subjects With Primary Immunodeficiency
Phase: IV
Principal investigator: Sriaroon, Panida
Department: Pediatrics
Sponsor: CSL Behring
Opening date: 8/14/2017

Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Essential Tremor
Phase: II
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: Cavion
Opening date: 8/14/2017

Title: A Double-Blind, Randomized, Placebo Controlled Study of the Efficacy and Safety of Three Doses of Orvepitant in Subjects With Chronic Refractory Cough
Phase: II
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: NeRRe Therapeutics Ltd
Opening date: 8/11/2017

Title: An Open-Label, Expanded Access Protocol for Amifampridine Phosphate (3,4-Diaminopyridine Phosphate) Treatment in Patients with Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenic Syndrome and Downbeat Nystagmus
Phase: N/A
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Catalyst Pharmaceuticals
Opening date: 8/9/2017

Title: A Phase 1 Study to Evaluate the Safety and Efficacy of 4 Transcranial Electromagnetic Treatment (TEMT) for the 5 Treatment of Alzheimer’s Disease.
Phase: I
Principal investigator: Smith, Amanda
Department: Psychiatry
Sponsor: NeuroEM
Opening date: 7/28/2017

Title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn’s Disease
Phase: III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 7/27/2017

Title: Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
Phase: III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 7/27/2017

Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD)
Phase: II
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 7/27/2017

Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease
Phase: II
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 7/27/2017

Title: An Open-Label, Randomized, Actual Use Study of Dupilumab Auto-Injector Device in Patients With Atopic Dermatitis
Phase: III
Principal investigator: Casale, Thomas
Department: Internal Medicine
Sponsor: Regeneron
Opening date: 7/25/2017

Title: A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants With Early Parkinson’s Disease With a 52-Week Blinded Extension
Phase: II
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Roche
Opening date: 7/25/2017

Title: An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson’s Disease Subjects Who Completed Study IN 11 004
Phase: IIIb
Principal investigator: Hauser, Robert
Department: Neurology
Sponsor: Intec Pharma
Opening date: 7/20/2017

Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects With HIV and With Hyperlipidemia and/or Mixed Dyslipidemia
Phase: IIIb
Principal investigator: Morano, Jamie
Department: Internal Medicine
Sponsor: Amgen
Opening date: 7/17/2017

Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects With Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer’s Disease Dementia
Phase: II
Principal investigator: Fils, Jean
Department: Psychiatry
Sponsor: Eisai
Opening date: 7/17/2017

Title: A Multicenter, Randomized, Double Blind, Placebo-Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Relapsing-Remitting Multiple Sclerosis
Phase: IV
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Mallinckrodt Pharmaceuticals
Opening date: 7/14/2017

Title: A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of ARGX-113 in Patients with Myasthenia Gravis Who Have Generalized Muscle Weakness
Phase: II
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Argenx
Opening date: 7/11/2017

Title: Multicenter, Non-Comparative Extension to Study AC-058B301, to Investigate the Long-Term Safety, Tolerability and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis
Phase: III
Principal investigator: Robertson, Derrick
Department: Neurology
Sponsor: Actelion
Opening date: 7/11/2017

Title: A Phase 3, Open-Label, Randomized, Multicenter, Controlled Trial to Evaluate the Pharmacokinetics Andpharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)
Phase: III
Principal investigator: Rico, Juan
Department: Pediatrics
Sponsor: Daiichi Sankyo
Opening date: 6/29/2017

Title: A Phase 2a, Double-Blind, Placebo-Controlled, Randomized Withdrawal Proof of Concept Study Evaluating the Activity, Safety, Tolerability, and Pharmacokinetics of SAGE-217 Oral Solution in the Treatment of Subjects With Essential Tremor (ET)
Phase: IIa
Principal investigator: Zesiewicz, Theresa
Department: Neurology
Sponsor: SAGE Therapeutics, Inc.
Opening date: 6/23/2017

Title: Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn’s Disease
Phase: III
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 6/21/2017

Title: A Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis
Phase: IIb
Principal investigator: Vu, Tuan
Department: Neurology
Sponsor: Mallinckrodt Pharmaceuticals
Opening date: 6/21/2017

Title: A Phase 3, Multinational, Multicenter, Open-Label Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10% in Adults and Children With Primary Immunodeficiency Diseases
Phase: III
Principal investigator: Leiding, Jennifer
Department: Pediatrics
Sponsor: ProMetic BioTherapeutics
Opening date: 6/19/2017

Title: Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Phase: IIb
Principal investigator: Marcet, Jorge
Department: Surgery
Sponsor: Gilead
Opening date: 6/14/2017

Title: Randomized, Controlled Trial Comparing Separation of Components Repair With Retrorectus MatriStem Surgical Matrix versus Underlay or Overlay Biologic or Prosthetic Mesh for Open Ventral Hernia Repair
Phase: I
Principal investigator: Velanovich, Vic
Department: Surgery
Sponsor: ACell, Inc.
Opening date: 6/12/2017