Carolinas HealthCare System
Neuroscience
Neuroscience Locations

Neuroscience Clinical Trials

Current Alzheimer's disease ongoing and enrolling studies including description

Study and Contact Information
Description

Expedition (sponsored by Eli Lilly)

Protocol #: H8A-MC-LZAX

Principal Investigator: Oleg V. Tcheremissine, MD

Coordinators: Dineen Gardner - 704-446-7511 & Megan Kramer - 704-446-0803

The purpose of this study is to help determine the safety and effectiveness of an investigational drug, solanezumab. “Investigational” means the study drug is currently being tested. It is has not been approved for routine clinical use nor for the use described in this study by the United States Food and Drug Administration (FDA). However, the FDA has allowed the use of this drug for research.

Researchers want to determine if solanezumab will slow mental and functional decline in individuals with mild Alzheimer’s.

Current, ongoing and enrolling ALS studies with a brief description

Study and Contact Information
Description

DPS (sponsored by MDA and ALSA)

Protocol #: HUD #10-0242

Principal Investigator: Benjamin Brooks, MD

Principal Investigator: Benjamin Brooks, MD

Coordinator: Cynthia Lary - 704-446-6063

This study is being done to find out if the NeuRx® Diaphragm Pacing System™ (DPS) will improve breathing function or prolong life span in people with ALS. The study also aims to compare measures of diaphragm function, dyspnea and quality of life between the standard of care group and DPS group.

Study participants must be at least 21. They will be randomized into one of two groups. One group (two-thirds of participants) will receive the DPS, and the other group (one-third of participants) will receive standard medical care for ALS. Participants receiving standard medical care will be the “control” group in order to tell whether the effects seen are truly from the DPS.

The study sponsors are the Muscular Dystrophy Association and the ALS Association.

Exercise (sponsored by Johns Hopkins)

Protocol #: NA_00022650

Principal Investigator: Benjamin Brooks, MD

Coordinator: Cynthia Lary - 704-446-6063

The purpose of this study is to see whether one type of exercise is tolerated better and is safer than another for people with ALS. Researchers also will collect information about how the body responds to exercise in people with ALS.

In this study, participants exercise in one of three ways: 1) weightlifting (resistance exercise); 2) stationary bicycling (endurance exercise) and; 3) range of motion/stretching exercise (the current “standard of care” for ALS patients). If resistance, endurance or range of motion exercise is shown to be well-tolerated and safe over 24 weeks, a larger trial will be planned to determining if exercise is beneficial to patients with ALS.

SOD1 (MDA)

Protocol #: None

Principal Investigator: Benjamin Brooks, MD

Coordinator: Rita Rouse - 704-446-1902

Researchers will collect a variety of information from participants’ medical records. That information includes ZIP code, gender, date of birth, month/year of ALS symptom onset, the month/year of permanent ventilation, and other pertinent data. This information will be entered into a database located at the study coordinating center, Washington University in St. Louis, MO. There are no clinic visits in this trial.

The study has two goals:
1. to collect survival data on every eligible subject and the rate of disease progression where available in order to define the natural history of familial ALS;
2. to determine if the natural history of SOD1 is different for certain areas of the US United States and Canada and determine if there are clusters of subjects in certain regions, which would provide guidance for future clinical trial site selection.

MDA Registry (sponsored by the Muscular Dystrophy Association)

Protocol #: None

Principal Investigator: Benjamin Brooks, MD

Coordinator: Rita Rouse - 704-446-1902

This is a study for children and adults who have been diagnosed with Amyotrophic Lateral Sclerosis (ALS), Duchenne Muscular Dystrophy (DMD), or Spinal Muscular Atrophy (SMA). The study is an ongoing data collection effort sponsored by the Muscular Dystrophy Association (MDA), known as the Patient Registry. The Patient Registry is designed to collect data – via a battery of questionnaires based on previous clinical assessments and patients’ own responses – on individuals with neuromuscular disease. Researchers want to better understand the disease progression and ultimately improve the care and survival of those with neuromuscular disease.

Subjects’ participation is expected to last for the duration of the study, which is continuous.

PRISM II

Protocol #: 12-AVR-401

Principal Investigator: Urvi Desai, MD

Coordinator: Rita Rouse - 704-446-1902

A study to assess the safety, tolerability, and effectiveness of NUEDEXTA (Dextromethorphan 20mg/Quinidine 10mg) in the Treatment of Pseudobulbar Affect. Pseudobulbar Affect symptoms include uncontrollable crying or laughter.

Ibudilast in ALS (sponsored by MediciNova Inc.)

Protocol #: MN-166-ALS-1201

Principal Investigator: Benjamin Brooks, MD

Coordinator: Cynthia Lary - 704-446-6063

The primary goal of this study is to evaluate the safety, tolerability and effectiveness of the investigational drug, ibudilast, when administered as an adjunct to riluzole in people with ALS.

Sixty subjects from 18 to 80 years old will be enrolled. Participants will be randomized (like flipping a coin) into 1 of 2 groups: group 1 will receive ibudilast with riluzole; group 2 will receive placebo (which looks like the ibudilast table, but has no active ingredients) with riluzole. This part of the study is called “double blind,” meaning neither the study staff nor the study patients will know which group the participants are in.

After completing the double-blind phase, subjects randomized to the placebo arm will begin to receive ibudilast for an additional 6 months so that researchers can further evaluate the drug’s safety and tolerability. If researchers find no concerns, they will decide whether to extend participation to the ibudilast-treated group for an additional six months.

Current ongoing and enrolling MS studies with a brief description

Study and Contact Information
Description

M.U.R.D.O.C.K.

Protocol #: Pr00011196

Principal Investigator: Jill Conway, MD

Coordinator: Bridget Loven - 704-446-1987

The purpose of this project is to collect and store blood and urine samples and health information. Researchers can then study the stored materials.

Through such studies, we hope to find new ways to detect, treat, and maybe even prevent or cure health problems.

STRATEGY (sponsored by Biogen Idec, Inc.)

Protocol #: 109MS412

Principal Investigator: Jill Conway, MD

Coordinator: Megan Kramer – 704-446-0803

The study will be conducted as a retrospective, observational study of patients with RRMS transitioning treatment from Tysabri to Tecfidera in routine clinical practice.

The primary objective of the study is to evaluate relapse activity, as measured by the proportion of patients relapsed at 12 months. The secondary objective is to further evaluate relapse activity, defined as Annual Relapse Rate (ARR), hospitalization and intravenous corticosteroid use, during the first year of Tecfidera treatment following transition from Tysabri treatment.

Approximately 500-700 patients are planned to be included in the study. There will be no dispensing of any study medication as part of this study.

EXPAND (sponsored by Novartis Pharmaceuticals)

Protocol #: CBAF312A2304

Principal Investigator: Jill Conway, MD

Coordinator: Maryanne Burdette - 704-446-1925

The purpose of this study is to evaluate the effectiveness and safety of BAF312 compared to placebo (a substance that looks like BAF312 but does not contain any active ingredient) in people with secondary progressive multiple sclerosis (SPMS). Subjects will take BAF312 or placebo once daily by mouth, as a tablet.

Approximately 8-10 people involved in this research study at CHS, and their participation will last for 23 to 42 months, but no more than 60 months. About 1,530 subjects with SPMS will join this study at approximately 250 to 300 centers worldwide.

Current ongoing and enrolling stroke studies including description

Study and Contact Information
Description

MISTIE III (sponsored by NIH/NINDS)

Protocol #: Pr00011196

Principal Investigator: Jason W. Todd, MD

Coordinators: Megan Kramer - 704-446-0803

The purpose of this study, sponsored by the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and Stroke (NINDS), is to evaluate the recovery of participants who have had a hemorrhagic stroke – a kind of bleeding in the brain – and receive drug therapy along with minimally invasive surgery.

The drug being investigated is rt-PA (recombinant tissue plasminogen activator), a medication approved by the Food and Drug Administration (FDA) to treat for dissolving blood clots in the heart and brain. It is not approved for use in hemorrhagic stroke, and the FDA is allowing the use of rt-PA in this study

This 500-subject clinical trial also compares the recovery of patients who receive rt-PA and surgery to the recovery of participants who receive standard medical care – that is, no surgery and no investigational drug.

Non-enrolling Studies

Study and Contact Information
Description

Opexa

Protocol #: 2012-00

Principal Investigator: Jill Conway, MD

Coordinator: Cynthia Lary - 704-446-6063

The purpose of this study is to evaluate the safety and effectiveness of Tcelna, an investigational T-cell (immune cell) product, compared to placebo (a substance that looks like Tcelna, but does not contain any active ingredient) in people with SPMS. An investigational product is one that is not yet approved by the U.S. Food and Drug Administration (FDA).

The T-cell product being studied is manufactured for each person individually, based on each person’s specific T-cell profile. Tcelna is designed to reduce or prevent the autoimmune attack (an attack by the body’s own cells) against the nervous system (brain and spinal cord) that is believed to cause MS or make it worse over time. In this study, we want to assess whether or not Tcelna is sage and effective in reducing the signs of SPMS. The primary way we will assess whether or not Tcelna is effective is by measuring the change in the size of the brain over time.

FTY720

Protocol # 2306E1

Principal Investigator: Jill Conway, MD

Coordinator: Joyce Pitner – 704-446-1349

This is the extension phase of the original FTY720-2306 study. The main purpose of this extension study is to continue to evaluate how safe and well tolerated the drug fingolimod is over the long-term in patients with PPMS who previously participated in the INFORMS core study. Other purposes are to evaluate efficacy of fingolimod over the long-term.

This study is open only to patients who participated in and completed the original study.

Sabril

Protocol #: 13098A

Principal Investigator: Bruce Mayes, MD

Coordinator: Rita Rouse - 704-446-1902

This study will monitor subjects' eye structure and function while taking Sabril® for the first time.

Then comparing the test results with the subjects perception of their ability to perform daily activities. A blood sample for exploratory DNA analysis with separate consent.

Ascend

Protocol #: CHS1-11-279

Principal Investigator: Jill Conway, MD

Coordinator: Megan Kramer - 704-446-0803

The main purpose of this research study is to see if natalizumab is effective in slowing the progression of disability independently of relapse in SPMS. Blood and urine samples will also be obtained and saved for future research on MS and on a virus called JC virus that sometimes causes infections in people taking natalizumab and other MS drugs. Finally, this study will test blood samples for biomarkers, which are naturally-occurring substances in the body, to try to learn more about how they change in MS and how they might be used to predict a patient’s response to treatment with natalizumab.

Oratorio

Protocol #: CHS1-11-353

Principal Investigator: Jill Conway, MD

Coordinator: Cynthia Lary, 704-446-6063

The purpose of this study is to investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by the time to onset of sustained disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 12 weeks, based on regularly scheduled visits. Also evaluating the time to sustained disability progression over the treatment period, defined as an increase in EDS S that is sustained for at least 24 weeks, the change in a timed 25-foot walk from baseline to Week 120, the change in total volume of T2 lesions on MRI scans of the brain from baseline to week 120, and to evaluate the safety and tolerability of ocrelizubab in patients with primary progressive multiple sclerosis as compared with placebo.

Mental Fatigue

Protocol #: 06-11-11E

Principal Investigator: Sanjay Iyer, MD

Coordinator: Rita Rouse - 704-446-1902

The purpose of this study is to determine if mentally fatigued patients will show a greater and faster decline in cognition over time. Because cognitive impairment impacts so many MS patients, we need an accurate way of predicting which patients will suffer a faster decline in their ability to think, concentrate, understand instructions, reason and accomplish minor tasks so we can start therapy early. By doing this study, we also hope to develop an inexpensive, complete, and reliable way to measure cognition in MS patients.

Stratify 2

Protocol #: CHS1-10-224

Principal Investigator: Sanjay Iyengar, MD

Coordinator: Rita Rouse - 704-446-1902

The purpose of this study is to determine whether antibodies to JC Virus (JCV) may be used to predict whether a patient is at higher or lower risk for developing Progressive Multifocal Leukoencephalopathy (PML).

Opera

Protocol #: CHS1-11-374

Principal Investigator: Jill Conway, MD

Coordinator: Joyce Pitner - 704-446-1349

The study drug ocrelizumab temporarily removes a type of white blood cells (B-cells) involved in the process of inflammation, which is believed to play a role in some symptoms of MS.
The purpose of this study is to confirm whether patients treated with ocrelizumab may experience fewer clinical relapses (also called clinical attacks or exacerbations) compared with those treated with Rebif®, a currently approved drug for MS

Pending Trials including description

Study and Contact Information
Description

Masitinib in ALS (sponsored by AB Science)

Protocol #: AB1010

Principal Investigator: Benjamin Brooks, MD

Coordinator: Cynthia Lary - 704-446-6063

The objective is to compare the efficacy and safety of masitinib combined with riluzole as add-on therapy versus placebo combined with riluzole as add-on therapy in the treatment of patients with ALS.

Approximately 210 subjects between 18 and 75 will be randomized into one of three groups: 70 patients will receive masitinib at 4.5 mg/kg/day + riluzole; 70 patients will receive masitinib at 3 mg/kg/day + riluzole; and 70 patients will receive placebo + riluzole. Their participation will last of 48 weeks.

ENHANCE (sponsored by Alexion Pharmaceuticals, Inc.)

Protocol #: ECU-MG-301

Principal Investigator: Elena Bravver, MD

Coordinator: Maryanne Burdette - 704-446-1925

 

The purpose of this study is to determine if a drug called eculizumab is safe and effective for the treatment of patients with refractory generalized myasthenia gravis (MG). MG is a rare and chronic neuromuscular disorder characterized by symptoms of weakness and muscle fatigue. Eculizumab is a type of drug called a “biologic,” meaning it comes from a living source (such as humans or animals). It has been approved to treat certain rare diseases, but is not approved for the treatment of MG; therefore, it is considered to be experimental for use in patients with MG.

Study subjects will be randomized into one of two groups: one group will receive eculizumab and the other placebo. During the 26-week period, patients will be infused with 10 mg of either the study drug or placebo; then a visit every 2 weeks for a total of 16 visits.

 

About Carolinas HealthCare System
Who We Are
Leadership
Community Benefit
Corporate Financial Information
Diversity & Inclusion
Annual Report
Foundation
Patient Links
Pay Your Bill
Hospital Pre-Registration
Patient Rights
Privacy
Financial Assistance
Quality & Value Reports
Insurance
Careers
Join Carolinas HealthCare System
Physician Careers

For Employees
Carolinas Connect
Connect with Us
Watch Carolinas HealthCare on YoutubeFollow Carolinas HealthCare on TwitterLike Carolinas HealthCare on FacebookContact Carolinas HealthCareJoin Carolinas HealthCare on LinkedInGo to our mobile website.