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Neuroscience Clinical Trials

Current Alzheimer's disease ongoing and enrolling studies including description

Study and Contact Information
Description

EnVivo (sponsored by Forum Pharmaceuticals)
Protocol #: EVP-6124-025A
Principal Investigator: Oleg V. Tcheremissine, MD

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

 

This study is being done for the investigational drug, EVP-6124 or encenicline. “Investigational” means the drug is not approved for sale by the U.S. Food and Drug Administration or any other regulatory or health agency.
The EnVivo study aims to determine if EVP-6124 is a safe and effective treatment for Alzheimer’s disease. EVP-6124 targets certain areas in the brain that contain receptors that are important for cognitive and memory functions.

The study is being conducted at 60-80 centers worldwide, including CMC-Neurology. Approximately 790 people will participate for up to 34 weeks (238 days). There will be at least 10 visits to the study site as well as contacts by phone. Subjects who complete this study may have the option to participate in a separate study during which they would receive EVP-6124 for an additional 26 weeks (182 days). Individuals who do not participate in the extension study will be contacted by phone 30 days after the last time they took the study drug.
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 determine the safety and effectiveness of the investigational drug solanezumab. Specifically, researchers want to know if solanezumab will slow mental and functional decline in individuals with mild Alzheimer’s.
About 2,100 people will enroll in the study. Each person will be assigned to one of two study groups using a chance process (like flipping a coin). One group will receive solanezumab and the other, placebo. Placebo looks like the study drug but does not contain any active ingredient.
Approximately 10 people are expected to be involved in this research study at CMC-Neurology, and participation will last for 18 months.

Potential participants must be 55-90 years old, and meet a variety Alzheimer’s-related mental and cognitive criteria based on established medical standards.

Current, ongoing and enrolling ALS studies with a brief description

Study and Contact Information
Description

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 tablet, but has no active ingredients) with riluzole. This part of the study is called “double blind,” because 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.

DPS (sponsored by MDA and ALSA)

Protocol #: HUD #10-0242

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.

SOD1 (sponsored by Muscular Dystrophy Association - 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.

Exercise (sponsored by Johns Hopkins University)

Protocol #: NA_00022650

Principal Investigator: Benjamin Brooks, MD

Coordinator: Rita Rouse – 704-446-1902

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 “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 determine if exercise is beneficial to ALS patients.

MDA Patient Registry (sponsored by MDA)

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), Becker muscular dystrophy (BMD) or spinal muscular atrophy (SMA). The study is an ongoing data collection effort known as the Patient Registry and sponsored by the Muscular Dystrophy Association (MDA). The Patient Registry collects data – via several questionnaires based on previous clinical assessments and patients’ own responses – from 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

Current ongoing and enrolling MS studies with a brief description

Study and Contact Information
Description

ENHANCE (sponsored by Biogen Idec)

Protocol #: 218MS305

Principal Investigator: Donna Graves, MD

Coordinator: Joyce Pitner – 704-446-1349

 

This research aims to examine how the drug prolonged-release fampridine affects aspects of walking and balance that have not been studied previously in patients with multiple sclerosis. There is an optional DNA research sub-study in which participants in the main study may also take part.
Potentially eligible participants must be 18-70 years old and be diagnosed with primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting MS.

Approximately 590 individuals with MS will be enrolled in the study; 6 persons will participate at CMC-Neurology, and participation will last 24 weeks.

STRATEGY (sponsored by Biogen Idec)

Protocol #: 109MS412

Principal Investigator: Jill Conway, MD

Coordinator: Megan Kramer – 704-446-0803

 

The research will be conducted as a retrospective, observational study of patients with relapsing remitting multiple sclerosis, who are transitioning treatment from Tysabri® to Tecfidera® in routine clinical practice.

The primary objective is to evaluate relapse activity as measured by the proportion of patients who’ve 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 will be included in the study. There is no dispense of 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 (which looks like BAF312 but does not contain any active ingredient) in people with secondary progressive multiple sclerosis (SPMS). Subjects will take a BAF312 tablet or placebo once daily by mouth.

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 250 to 300 centers worldwide.

Current ongoing and enrolling myasthenia gravis studies including description

Study and Contact Information
Description

ECULIZUMAB (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 (humans or animals). It has been approved to treat certain rare diseases, but is not approved to treat 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 study 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.
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