Clinical trial information changes on a daily basis. Many clinical trials accept only a limited number of participants. Further, new trials are added on a routine basis as they are approved by the various institutions involved. Therefore, we suggest you check back often if you are interested in a specific treatment for a specific condition  in order to review your options. 
 Currently enrolling clinical trials.

What are clinical trials?
Clinical trials -- also called clinical studies, experiments, investigations, or research -- test new treatments in people. Progress in medicine simply doesn't happen without clinical trials. Research labs can invent wondrous new drugs and other therapies, and research labs can find marvelous results in lab animals, but without testing in people, a new treatment's true potential for improving human health will never be known. Clinical trials are studies, managed by government agencies, educational institutions, private not-for-profit organizations, or commercial businesses, to develop, produce, and evaluate the effectiveness of new treatments and therapies for diseases.

What are the risks and benefits of participating in a clinical trial?
Individuals who participate in research studies are given the opportunity to benefit from treatments that are not currently available to the general public, but have shown promise in previous research. Risks from participating in a clinical trial vary depending on the study. It is important to understand that not all new treatments produce the desired effect.

Thinking about participating in Clinical Research Trials?
Clinical research studies are special, highly structured programs in which we learn more about Parkinson’s disease and related disorders.  Drug trials are designed so that we are able to evaluate new medications to see if they are safe and effective. Each trial or study will have a very specific set of illness characteristics which the patient must meet if they wish to participate (“inclusion” and “exclusion” criteria).  These may include medications you have been on, how long you have had your illness, and the state of your health in general.

Drug trials as a treatment option
As physicians specializing in the treatment of Parkinson’s disease, we believe patients' involvement in research studies is a good idea, for very specific reasons:

• The overall treatment of Parkinson's disease for all patients can be improved when people with Parkinson's agree to participate in programs that test drugs.
  
• In clinical research trials, new treatments are tested on patients in carefully planned studies designed or monitored by physicians and statisticians, and participants in these trials may have access to helpful drugs years before the drugs are available to others.
  
• People who participate in clinical trials tend to do better than people who do not, even when they receive a placebo rather than the actual test drug. This is because participants in clinical trials receive intense medical attention and monitoring; they are working with people who have a special interest in their disease; they are actively participating in controlling their disease; and they feel better.

A clinical trial can measure the benefit of a new medication by comparing the treatment to an inactive substitute (“placebo”). When neither you nor your doctor knows whether you are taking the active or inactive pill (“double-blinded”), it becomes a very objective way to evaluate a new drug. Because the medication has been tried in relatively few people, you are monitored very closely for any side effects with physical examination, blood work and other tests.  The cost of this care and the medication are generally not your responsibility. 

Before you can enter any study, we obtain your written informed consent. This document lists all the things that you might expect during the course of the trial, and the details of the study. In this way we know that you understand exactly what you are agreeing to, and that it has been fully explained to you.

As a patient volunteer, you have the right to stop your participation in any trial, at any time, without any penalty to you. This will not affect your future care at MUSC. The new drugs available in clinical trials for your illness are just like any other tool that we have on the shelf to help us care for you. It is our job to tell you everything that is available for your care, help you evaluate your choices, and use them for your benefit.

Clinical trials are studies designed to find new and better ways to treat patients with Parkinson's disease and other movement disorders. The physicians of the MUSC Movement Disorders Program are currently conducting the clinical trials listed in our site.

New studies open frequently. If interested in specific information regarding our studies, please call our research office at (843) 792-7262.

Studies Currently Enrolling:

A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study in Subjects with Stably Treated Parkinson's Disease.  (Sponsor: National Institute of Neurological Disorders and Stroke, Neuroprotection Exploratory Trials in Parkinson’s Disease:   NINDS NET-PD)  This trial will study the possible efficacy of a new drug to delay the progression of Parkinson’s disease in patients who are on stable treatment, in the early stages of the disease. 

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single Treatment, Sequential Dose-Escalation, Safety, Tolerability and Preliminary Efficacy Study of MYOBLOC ^® for the Treatment of Troublesome Sialorrhea in Parkinson’s Disease Patients (Sponsor: Solstice Neurosciences, Inc.)  The goal of this study is to evaluate the effectiveness of MYOBLOC in the treatment of Sialorrhea (drooling) in patients with PD. 

A Multi-site, double-blind, randomized, placebo-controlled study of pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor (Sponsor: Movement Disorders Consortium of the Southeast) This 6 month study will evaluate the effectiveness of Lyrica in patients with Essential Tremor.

Effects of Coenzyme Q₁₀ on Early Parkinson’s Disease (Sponsor: Parkinson Study Group (PSG) The aim of this study is to compare the effect of 2 different doses of Coenzyme Q10 to placebo in patients with early Parkinson’s disease who have not yet developed sufficient disability to require treatment.

For patients with generalized dystonia:  Deep Brain Stimulation in Dystonia:  Humanitarian Device Exemption for Activa® Dystonia Therapy (Sponsor: Medtronic, Inc.)  We are a regional center for investigation of the use of Deep Brain Stimulation as a treatment for generalized dystonia.

Neuroimaging Investigation of Movement Disorders (Sponsor: The Murray Center for Research on Parkinson’s Disease and Related Disorders, MUSC  The purpose of this study is to identify the parts of the brain that cause a particular movement disorder. This study will examine scans from patients with movement disorders, and correlate their brain anatomy with their movement phenomenology, disease severity and their cognitive profile (performance on neuropsychological tests).

Studies closed to enrollment:

A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa/Carbidopa therapy.   (Kyowa Pharmaceutical, Inc)  This study aims at evaluating the efficacy and safety of this drug in patients with progressive Parkinson’s disease.

An Open-Label, Multicenter, Study of the Continued Safety of Istradefylline in Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline. (Kyowa Pharmaceutical, Inc)  This study investigates the safety of this drug in patients who have completed the above listed 12 –Week study.

A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 in Parkinson’s Disease. (Kyowa Pharmaceutical, Inc)  This ongoing study investigates the safety of this drug in patients who have completed the above listed 12 –Week study.

A Phase 2, Double Blind, Placebo Controlled, Randomized, Parallel Group Multicenter Study of the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) as Monotherapy in Subjects with Parkinson’s Disease. (Kyowa Pharmaceutical, Inc)  This three month study investigates the usefulness and safety of this novel drug in early PD before any other medication treatments have been used.

A Randomized, Double-blind, Crossover Study to Compare IPX 054 200 mg tablet BID to carbidopa-levodopa immediate release 100 mg tablet QID in subjects with Parkinson’s Disease (Sponsor: IMPAX Laboratories)  The goal of this project is to compare IPX 054 (a new formulation of carbidopa/levodopa) 200 mg tablet twice a day to the standard carbidopa-levodopa immediate release 100 mg tablet four times a day.  It is a brief crossover trial comparing two active treatments in a month’s time.

For patients with focal dystonia: writer’s cramp or cervical dystonia (spasmodic torticollis).  Functional Imaging of Motor Circuits in Dystonia (Sponsor: MCRPD, MUSC).  We are investigating how brain circuits for movement are altered in dystonia by use of functional magnetic resonance imaging (fMRI).  Dr. Vanessa Hinson is conducting these studies which are very noninvasive and require the ability to perform simple motor tasks during a special kind of MRI brain scan. 
 

Geographic Variation of Parkinson’s Disease in South Carolina: (Sponsors: The Fullerton Foundation, The Close to A Cure Foundation,  United States Geological Survey (USGS),  and  The Murray Center for Research on Parkinson’s Disease and Related Disorders, MUSC)  This project will attempt to create a model which predicts the development of PD.  We know that this illness results from a complex interaction of environmental, biological, and genetic risk factors that an individual may carry. We are performing an in-depth interview of patients with PD, using a spouse, friend or family member as a control subject.  We will combine their lifetime list of possible environmental and familial factors with data about SC soil and water that we obtain from a variety of other environmental sources.  To participate you must have parkinsonism and have lived in one of the following SC zip codes for the five years before the first symptom of your illness:
 
29003, 29006,29018, 29038, 29039,29048, 29054, 29059, 29070, 29082, 29105, 29107, 29112, 29113, 29115, 29116, 29117, 29118, 29129, 29123, 29133, 29135, 29142, 29146, 29160,  29163, 29166, 29401, 29403, 29405, 29406, 29407, 29412, 29414, 29417, 29418, 29420, 29429, 29431, 29432, 29433, 29435, 29436, 29437, 29438, 29439, 29445, 29446, 29447, 29448, 29450, 29451, 29452, 29455, 29456, 29458, 29461,29464, 29466, 29470, 29471, 29472, 29474, 29475, 29477, 29481, 29483, 29484, 29485, 29487, 29488, 29493,29817, 29832, 29902, 29910, 29912, 29918, 29920, 29923, 29924, 29926, 29927, 29928, 29929, 29932, 29933, 29934, 29936, 29940, 29944, 29945

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson’s Disease Patients with Motor Fluctuations (Sponsor:  Eisai Medical Research, Inc.)  The purpose of this study is to evaluate whether E2007 is effective in reducing the amount of “OFF” time a PD patient experiences throughout the day when used in conjunction with Levodopa.  Safety and tolerability of E2007 will also be assessed in this patient population. 

A Multi-Center, Open Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of E2007 as an adjunctive Therapy in Levodopa Treated Parkinson’s Disease Patients with Motor Fluctuations (Sponsor:  Eisai Medical Research, Inc.)  This is an extension of the above listed study “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson’s Disease Patients with Motor Fluctuations.”  The purpose of this study is to evaluate whether E2007 is effective in reducing the amount of “OFF” time a PD patient experiences throughout the day when used in conjunction with Levodopa.  Safety and tolerability of E2007 will also be assessed in this patient population.

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