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Could You Benefit From Potential Treatments Accessible Through Clinical Research Studies?

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You can play an active role in bringing new therapies to the community by participating in clinical research studies. Clinical trials are studies in which researchers test new drugs for safety and effectiveness. Participating in clinical studies gives you a chance to advance and accelerate research, access emerging therapies that are being studied, and help bring new therapies to the community. Talk to your doctor to learn more about clinical trials.

When a pharmaceutical company develops a new drug, it sponsors a clinical trial to test the drug in people with the disease for which it was intended. The process is regulated by the Food and Drug Administration (FDA). The FDA’s approval is required before a drug is allowed to be used. Natural products such as vitamins or food supplements, which are commonly sold in health food stores as alternative medicines, are not regulated by the FDA, and are not required to undergo clinical trials.

Listed below are some neuropathy clinical trials that are currently looking for participants. For a more comprehensive list of neuropathy clinical trials and to locate clinical trials in your vicinity, visit www.clinicaltrials.gov and search using the words “neuropathy” and the name of the city you live in (e.g., neuropathy, New York City).

Tetrodotoxin (TTX) for Pain Resulting from Chemotherapy Treatment

Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of many chemotherapeutic agents, including vincristine, paclitaxel, cisplatin, oxaliplatin, bortezomib, and ixabepilone.Chemotherapy-induced peripheral neuropathy occurs in greater than 40% of patients. For this segment of our community, neuropathy and neuropathic pain is the “price of survival” that severely compromises quality of life and daily function. To improve the peripheral neuropathy, the chemotherapy dosing is often either decreased or discontinued potentially affecting tumor responsiveness, prognosis, and survival. There is an unmet medical need for treatment of cancer patients with chemotherapy-induced neuropathic pain (CINP). This clinical research study aims to investigate the efficacy and safety of multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic pain caused by chemotherapy. Read more...

Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating Polyneuropathy

Chronic inflammatory demyelinating polyneuropathy is disease believed to be due to immune cells, cells which normally protect the body, but are now attacking the nerves in the body. As a result, the affected nerves fail to respond, or respond only weakly, to stimuli causing numbing, tingling, pain, and progressive muscle weakness. The likelihood of progression of the disease is high. This study is designed to examine whether treating patients with high dose cyclophosphamide (a drug which reduces the function of the immune system) and ATG (a protein that kills the immune cells that are thought to be causing your disease), followed by return of the previously collected blood stem cells will stop the progression of CIDP. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the high dose cyclophosphamide and ATG is to destroy the cells in the immune system. The purpose of the stem cell infusion is to evaluate whether this treatment will produce a normal immune system that will no longer attack the body. Read more...

Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

Currently available treatments for patients with type 1 diabetes focus on replacing insulin, but not C-peptide. In healthy individuals, C-peptide and insulin are co-secreted in equal amounts into circulation.  But in patients with type 1 and some patients with type 2 diabetes, destruction of the beta cells results in deficiency of both insulin and C-peptide. The purpose of this clinical research study is to determine the beneficial effects of CBX129801 (Ersatta™) -- a long-acting synthetic human C-peptide -- following weekly subcutaneous administration for 12 months in type 1 diabetes mellitus patients with mild to moderate diabetic peripheral neuropathy. Read more...

Efficacy and Saftety of ISIS TTR Therapy for Familial Amyloid Polyneuropathy

Familial Amyloid Polyneuropathy is a rare, hereditary disease caused by mutations in the transthyretin (TTR) protein. TTR is made by the liver and secreted into the blood. TTR mutations cause it to misfold and deposit in multiple organs causing FAP. When the nervous system is involved, patients present with progressive sensorimotor and autonomic neuropathy. The purpose of this clinical research study is to determine if ISIS TTR Rx can slow or stop the nerve damage caused by TTR deposits. This study will enroll late Stage 1 and early Stage 2 FAP patients. Patients will receive either ISIS TTR Rx or placebo for 65 weeks. Read more...

A Study Assessing the Safety and Tolerability of Fingolimod as an Oral Therapy for CIDP 

This clinical research study seeks to evaluate the safety and tolerability of fingolimod (FTY720) 0.5 mg -- administered orally once daily -- in the treatment of people with chronic inflammatory demyelinating neuropathy (CIDP). Fingolimod is a sphingosine 1-phosphate receptor (S1PR) modulator. It interacts with S1P receptors located on lymphocytes (a type of immune cell that is made in the bone marrow and is found in the blood and in lymph tissue). This interaction causes the lymphocytes to sequester in the lymph nodes, thus preventing them from moving towards, and damaging, targeted parts of the body. In experimental autoimmune neuritis, a T cell-mediated model of CIDP, fingolimod completely suppressed partial paralysis affecting the lower limbs (or paraparesis) and significantly decreased T-cell, B-cell, and macrophage infiltration and demyelination of sciatic nerves. Read more...

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

This clinical study seeks to assess subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP). Patients on intravenous immunoglobulin (IVIG) maintenance therapy enrolled in this clinical research study will be assessed during three separate study periods. Patients first undergo a period of up to 12 weeks to test for on-going need of immunoglobulin therapy. Those patients will be administered IVIG during an IVIG re-stabilization period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization period will continue to the subcutaneous (SC) treatment period of the study. Patients entering the 24 week SC treatment period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo. Read more...

Genetic and Physical Study of Childhood Nerve and Muscle Disorders

The National Institute of Neurological Disorders and Stroke (NINDS) is conducting a clinical research study aimed at diagnosing patients with neuromuscular and neurogenetic disorders with congenital or pediatric onset and to studying the natural history and mechanism of these disorders. Some nerve and muscle disorders that start early in life (before age 25), like some forms of muscular dystrophy, can run in families. However, the genetic causes of these disorders are not known. Also, doctors do not fully understand how symptoms of these disorders change over time. Researchers want to learn more about genetic nerve and muscle disorders that start in childhood by studying affected people and their family members, as well as healthy volunteers. Read more…

 

Efficacy and Safety of ALN-TTR02 for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis

The purpose of this clinical research study is to evaluate the efficacy and safety of the investigational drug patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis (also known as Familial Amyloidotic Polyneuropathy or FAP). FAP is an inherited, progressively debilitating, and fatal disease caused by mutations in the TTR gene. TTR protein is produced primarily in the liver and is normally a carrier for retinol binding protein. Mutations in TTR cause abnormal amyloid proteins to accumulate and damage body organs and tissue, such as the peripheral nerves and heart, resulting in intractable peripheral sensory neuropathy, autonomic neuropathy, and/or cardiomyopathy. Read more...

Cognitive Behavioral Therapy for Diabetic Neuropathic Pain

The purpose of this clinical research study is to evaluate the efficacy of cognitive behavioral therapy (CBT) for the management of persistent pain associated with diabetic peripheral neuropathic pain. Study participants will be evaluated pre-treatment (baseline), 12 weeks post-baseline (post-treatment), and at 36 weeks post-baseline (follow-up). Baseline assessment will include a physical examination to confirm the diagnosis of diabetic neuropathy. The primary outcome measure will be pain intensity. Secondary outcome measures will be pain quality, pain-related disability, and physical and emotional functioning. Measures of treatment feasibility will also be examined. CBT plus standard pharmaceutical care (CBT/SC) is compared to an educational intervention plus standard pharmaceutical care (ED/SC) treatment condition.CBT and ED will be provided in 10 weekly, individual treatment sessions of 60 minutes. Read more...

Milnacipran for the Treatment of Idiopathic Neuropathy Pain

Many clinical trials for neuropathic pain are done in patients with diabetic neuropathy. Idiopathic neuropathy, however, is a common diagnosis and accounts for 25% of all neuropathies, and over 50% of small fiber neuropathies. The information in the clinical research study on milnacipran—an experimental medication that helps serotonin and noradrenaline work more effectively on the central nervous system—being conducted at Columbia University in New York—will provide information on whether the drug provides benefit as a medication for idiopathic neuropathic pain. Read more...

Improving Neuropathy and Mobility In Early Diabetes

 Neuropathy is the most common complication of diabetes mellitus. Impaired glucose regulation (IGR) is associated with development of peripheral neuropathy coupled with gait and mobility impairment that may be disabling for the patient.. Investigators at the VA Maryland Health Care System and University of Maryland (Dr. James Russell), and Ann Arbor VAMC and University of Michigan (Drs. Neil Alexander and Kim Gretebeck) are conducting a study on patients with impaired glucose tolerance or who have recently been diagnosed with type II diabetes and also have peripheral neuropathy. The purpose of this study is to determine if an individually tailored diet and physical enhancement program can improve mobility, physical activity, and neuropathy in people with early diabetes. Read more...

Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis

 Sarcoidosis is an inflammatory disease that affects multiple organs in the body. In people with sarcoidosis, abnormal masses or nodules (called granulomas) consisting of inflamed tissues form in certain organs of the body that may alter the normal structure and possibly the function of the affected organ(s). Small-fiber neuropathy is one of the disabling and often chronic manifestations of the disease. The purpose of this clinical research study is to determine whether ARA 290 is effective in the treatment of the neuropathic symptoms of sarcoidosis. In this study, subjects with sarcoidosis and symptoms of small fiber neuropathy will be administered ARA 290 or placebo by subcutaneous injection daily for 28 days. In addition to monitoring the safety of the treatment, the symptoms of the subjects will be assessed with several questionnaires, function tests, and measurement of nerve fibers in their cornea and skin (via a non-invasive test and a biopsy, respectively). Read more... 


 
 
 
 
 
 
 
 

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