CONTRACTS (clinical trials)

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

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