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Neuroscience Clinical Trials

Current Alzheimer's Disease ongoing and enrolling studies with a brief 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

Study H8A-MC-LZAX (LZAX) is a Phase 3, placebo-controlled study in mild AD patients. This study is designed to collect data on the long-term safety and efficacy of solanezumab, including cognitive outcomes, as well as functional outcomes, quality of life, resource utilization, and biomarker measures. The purpose of this study is to see how safe an investigational drug is and how well it will work to help people with Alzheimer’s disease (AD). “Investigational” means that the study drug is currently being tested. It is not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (U.S. FDA). However the FDA has allowed the use of this drug for research. The primary purpose of your participation in this study is to determine if solanezumab will slow mental and functional decline in mild AD.

Current All Disease ongoing and enrolling studies with a brief description

Study and Contact Information
Description

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.

NUEDEXTA has been approved for the treatment of Pseudobulbar Affect symptoms by the U.S. Food and Drug Administration (the FDA). Pseudobulbar Affect symptoms of uncontrollable crying or laughter can be difficult to manage and can impact your quality of life. This study will add to the current clinical evidence which was gathered in amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS) patients and reaffirm NUEDEXTA is effective, safe and well-tolerated.

NUEDEXTA is developed and marketed by Avanir Pharmaceuticals for the treatment of Pseudobulbar Affect. It is a combination of two drugs called dextromethorphan and quinidine. Dextromethorphan is a drug that is available without prescription as an over-the-counter cough medication and has been in use for over 50 years. Quinidine is one of the oldest prescription drugs still in use. It is used to treat abnormal heart rhythms (arrhythmias). The usual dose used to treat arrhythmia is 600mg to 1600mg per day. The total daily dose of quinidine in this study is 20mg per day, which is much lower (30-80 times lower) than the dose normally used to treat cardiac arrhythmias.

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 Marie Conway, MD, MA

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.

Opexa

Protocol #: 2012-00

Principal Investigator: Jill Marie Conway, MD, MA

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.

Expand (sponsored by Novartis)

Protocol #: CBAF312A2304

Principal Investigator: Jill Marie Conway, MD, MA

Coordinator: Maryanne Burdette - 704-446-1925

A multicenter, randomized, double-blind, parallel-group, placebo controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis. This study is designed to provide efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis (SPMS) and to obtain regulatory approval to make BAF312 available for clinical use worldwide. BAF312 or placebo will be taken once daily, by mouth, as a tablet. Both tablets look the same and are packaged the same. BAF312 acts on certain types of blood cells, called lymphocytes (white blood cells), that are responsible for immune reactions (disease-fighting reactions in your body). These lymphocytes, while in the blood, are also believed to contribute to the process in the nervous system that results in MS symptoms.

Current ongoing and enrolling ALS studies with a brief description

Study and Contact Information
Description

Exercise (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. We will also collect information abut how the body responds to exercise in people with ALS.

In this pilot study we will ask participants with ALS to exercise in one of three ways: weightlifting (resistance exercise), stationary bicycling (endurance exercise) and 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.

Cytokinetics

Protocol #: CY4026

Principal Investigator: Benjamin Brooks, MD

Coordinator: Cynthia Lary - 704-446-6063

 

The purpose of this study is to investigate CK-2017357 (tirasemtiv) as a potential new therapy for the treatment of muscle weakness and muscle fatigue (tiredness) in patients with Amyotrophic Lateral Sclerosis (ALS).

This research study is to evaluate the safety and effectiveness of CK-2017357 and how well it is tolerated in patients with ALS. Additionally, the effects of CK-2017357 on the performance of your elbow, wrist, hand, knee and ankle muscles, your breathing, and how long you can maintain a task will be evaluated. How much of CK-2017357 gets into the blood stream and how long it takes the body to get rid of it will also be measured.

Information about any side effects that may occur will also be collected. The goal of this research study is to test the effectiveness and safety of CK-2017357 taken twice a day for 3 months for the treatment of muscle fatigue and muscle weakness in patients with ALS.

Current ongoing and enrolling PD studies with a brief description

Study and Contact Information
Description

CD Flex

Protocol #: MUS 60201 4073 1

Principal Investigator: Sanjay Iyer, MD

Coordinator: Maryanne Burdette - 704-446-1925

 

This study will compare a shorter treatment cycle (every 6 to 10 weeks) of Xeomin, a botulinum toxin injection for the treatment of cervical dystonia, to the standard treatment cycle (every 90 days to 16 weeks) to evaluate how effective the short cycle is compared to the standard cycle, and to determine if more frequent dosing leads to development of botulinim toxin resistance (making treatment with botulinum toxin less effective).

Subjects will be asked to complete questionnaires regularly throughout the study; some of the questions will be asked while the subject is at the clinic, and some questions will be asked when the subject telephones into an Interactive Voice Response System.

Current ongoing and enrolling Epilepsy studies with a brief description

Study and Contact Information
Description

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.

Velocity

Protocol #: SP0993

Principal Investigator: Rajdeep Singh, MD

Coordinator: Carissa Tonkins - 704-446-0836

 

The purpose of this study is to see if Lacosamide (LCM) when taken alone increases the number of seizure free days in a similar way to carbamazepine controlled release (CBZ-CR). Another reason is to find out if there are side effects when LCM is used without other anti-epileptic drugs.

The side effects will also be compared to the side effects experienced when taking CBZ-CR. The FDA does not consider that the results of this study can address the question whether LCM is effective in treating epilepsy when used alone. Because it is unknown if LCM will work as a stand-alone treatment, you may still experience seizures.

Current ongoing and enrolling Stroke studies with a brief description

Study and Contact Information
Description

POINT

Principal Investigator: Phaniraj Iyengar, MD

Coordinator: Megan Kramer - 704-446-0803

A study to evaluate whether clopidogrel given 75mg/day after an initial dose of 600mg is effective in preventing major ischemic vascular events (such as ischemic stroke, myocardial infarction and ischemic vacular death) at 90 days when initiated 12 hours after the onset of TIA symptoms or minor ischemc stroke onset in patients receiving aspirin 50-325mg/day.

MISTIE III (sponsored by NIH/NINDS)

Protocol #: ICH02

Principal Investigator: Phaniraj Iyengar, MD

Coordinators: Megan Kramer - 704-446-0803

 

A phase III, randomized, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage. 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 receive rt-PA (recombinant tissue plasminogen activator) along with minimally invasive surgery in individuals who have been diagnosed ICH. The study further 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.
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