Research / Clinical Trials

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Brenda Whitehead, CCRP, Kimp Puccio, LPN CRC and Lisney Dunlap, CMA CRC

Our practice offers clinical trials which help determine whether newly developed treatments are safe and effective in treating Multiple Sclerosis. These studies are important research tools for developing new treatment options for this chronic disease. Clinical trials also provide patients with access to new treatment options and new therapies that are not offered to the general population.

As new technologies and therapeutic options become available, Hope Neurology Multiple Sclerosis Center utilizes clinical trials to provide innovative treatment options to our patients.

Clinical research studies provide patients with new medications and access to comprehensive disease management. By working closely with our pharmaceutical sponsors, we strive to improve the health, hope and well-being of our patients.

For more information on any of our studies, please call 865-218-6222 and ask to speak with Brenda, Kim Puccio or Linsey or email us at hnresearch@hopeneuro.com

CONTACT INFORMATION

2060 Lakeside Center Way
Knoxville, TN 37922
865.218.6222 Phone
865.218.6220 Fax

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OFFICE HOURS:
Monday-Thursday 8am – 4:30pm

PATIENT PORTAL LINK

GWSP18023 GW Research Limited 

Release

A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis

Upcoming

RCP1063-MS-001 Receptos

Enlighten

Celgene RPC1063-MS-001:  Phase 3b, Multicenter, Open Label, Single Arm Study Evaluating the Impact of a study drug on Cognitive Processing Speed in Patients with Relapsing Multiple Sclerosis

Currently Enrolling

GN41791 Genentech Roche

Fentrepid

A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH OCRELIZUMAB IN ADULT PATIENTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Currently Enrolling

GN42272 Genentech Roche

Fentrepid

A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND,  DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS

Currently Enrolling

EFC16034-Gemini II Sanofi

Gemini II

A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunimode in participants with relapsing forms of Multiple Sclerosis. 

Currently Enrolling

RMSMS200527-00780 EMD Serono

Evolution

STUDIES Phase III Trial: Multicenter, Randomized, Parallel-Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib with an Active Control Group Interferon Beta-1a (Avonex®), in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety

Currently Enrolling

Novartis CBAF312AUS02

Exchange

Exploring the safety and tolerability of conversion from oral or injectable disease modifying therapies to dose-titrated Oral Siponimod in patients with advancing forms of relapsing-remitting multiple sclerosis: A 6-month open label, multi-center Phase IIIb study.  

Currently Enrolling

BN42082 Musette Genentech Roche

Musette

A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS

Currently Enrolling

TG1101RMS303 TG Theraputics

TG303 Extension

TG1101-RMS303 is an open-label, single-arm extension study designed to evaluate long-term safety and efficacy of ublituximab in subjects with Relapsing Multiple Sclerosis. Subjects who complete the 96-week, double-blind treatment period of TG1101-RMS301 or TG1101-RMS302 are eligible for participation in this Open Label Extension (OLE) study.

Ongoing in Follow Up 

Biogen 101MS329

Nova

Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) in participants who have previously been treated with natalizumab standard interval dosing (SID) for at least 12 months, in relation to continued SID treatment. The secondary objectives is to evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of EID in participants who have previously been treated with natalizumab SID for at least 12 months, in relation to continued SID treatment.

Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC) versus intravenous (IV) route of natalizumab administration. The secondary objectives is to evaluate treatment satisfaction, drug preparation and administration time, safety and immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug preparation and administration time of SC versus IV routes of natalizumab administration.

Ongoing in Follow Up 

Receptos RPC01-3001

DayBreak

The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301, and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to receive study drug until the end of the trial or until the Sponsor discontinues the development program.

Ongoing in Follow Up 

LTS16004 Sanofi

To determine the long-term safety and tolerability of SAR442168 in RMS participants. To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods

Ongoing in Follow Up 

Sanofi OBS13434

Pass

Post Market Follow Up study for Lemtrada

Ongoing in Follow Up 

BA39731 Hoffman-LaRoche

Verismo

AN OBSERVATIONAL STUDY OF OCRELIZUMAB-TREATED PATIENTS WITH MULTIPLE SCLEROSIS TO DETERMINE THE INCIDENCE AND MORTALITY RATES OF BREAST CANCER AND ALL MALIGNANCIES (VERISMO STUDY) 

Ongoing in Follow Up 

Biogen105MS401

POP

The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.

Ongoing in Follow Up 

Biogen US-VUM-11760

Experience

A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting

Ongoing in Follow Up