NeuroSearch USA Neurosearch is a research company that for years has done Observational, Phase II and III clinical

trials in the Southern California area in Parkinson's Disease, Epilepsy, Multiple Sclerosis and other movement disorders. They have programs in Reseda, Ventura, and Pasadena, California (where Dr. Jerome Lisk participates). Their goals are to provide local, focused patient care that includes more one-on-one time with Physicians and Staff and provide resources that will help advance the cause of clinical research. Neurosearch has established their reputation as highly competent research sites with extremely positive patient and clinical trial sponsor feedback.

PDTrials PDtrials is a collaborative initiative of Parkinsons organizations dedicated to increasing education and awareness about clinical research. Central to this effort is providing information to help people with Parkinsons learn more and make informed decisions about participating in clinical studies. In the last decade, there has been an explosion of new research ideas for Parkinson's and other diseases of the brain. These discoveries need to be tested in clinical trials before they become available to the public.

Open Trials (2011) Orthostatic Hypotension Trial A study of an investigational medication for treatment of Orthostatic Hypotension The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency. Parkinson's Disease Psychosis Trial Do you or a loved one suffer from Parkinsons Disease?

Eligibility

Ages Eligible for Study: 40 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No

In addition to Parkinson's symptoms, are you or the person you care for bothered by any of the following experiences:

Seeing things that other people cannot see? Hearing things that other people cannot hear? Believing that you cannot trust others? Believing that others are trying to hurt you? Other similar thoughts, beliefs, or feelings?

Study of Preladenant in People With Moderate to Severe Parkinson's Disease A Phase 3, 12 Week, Double Blind, Placebo and Active Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3; Protocol No. P04938) When people are not experiencing symptoms of Parkinsons disease because of their treatment with medication, they are considered in an on state. As the medication wears off and the symptoms of PD re-appear they are considered in an off state. This research study will test how effective an investigational medication, Preladenant, might be in treating certain side effects caused by levodopa treatment. Different dose levels of the medication, will be compared to placebo (looks like the investigational medication but does not contain the active ingredient) and rasagiline (an approved medicine) when added to levodopa. Study of Preladenant in People with Early Parkinson's Disease A Phase 3, Double Blind, Placebo and Active Controlled Dose Range Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease (Phase 3 Protocol No. P05664) This study will test the safety and effectiveness of an investigational medication, Preladenant, for the symptoms of Parkinsons disease. Different dose levels of the

medication will be compared to rasagiline (an approved medication) and placebo (looks like the investigational medication but does not contain the active ingredient).

About Parkinson's disease

Parkinson's disease is a degenerative disorder of the central nervous system that results from the death of cells in the substantia nigra, a region of the midbrain. Early in the course of the disease, the most obvious symptoms are movementrelated, including shaking, rigidity, slowness of movement and difficulty with walking. Later, cognitive and behavioral problems may arise, with dementia commonly occurring in the advanced stages of the disease. Other symptoms can arise such as sleep and emotional problems. Four motor symptoms are used to diagnose Parkinson's Disease: tremor, rigidity, slowness of movement, and postural instability. Parkinson's disease can cause psychiatric disturbances that effect cognition, mood, behavior, and thought. It can also impair other body functions such as sleep, cause daytime drowsiness, disturbances in REM sleep, and insomnia, low blood pressure upon standing, oily skin and excessive sweating, urinary incontinence and altered sexual function. PD traditionally has been considered a non-genetic disorder. Strangely, around 15% of individuals with PD have a first-degree relative who has the disease. There is no cure for Parkinson's disease, but medications, surgery and management can provide relief from the symptoms

Dosage & its Side effects: The 12-week study found that the addition of 5 and 10 mg of preladenant twice daily significantly reduced "off time" -- the re-emergence of troublesome motor symptoms such as slowness, stiffness, tremors, and immobility - when compared to patients receiving similar doses of placebo. Futhermore, preladenant significantly increased "on time" - the period during which patients' Parkinson's symptoms were adequately controlled --.without significantly worsening dyskinesia (involuntary twisting, turning movements). The doses were well tolerated, and

the incidence of treatment-related adverse effects was similar for patients receiving preladenant and placebo. In Parkinson's disease, the brain's dopamine-producing cells falter and die, leading to movementrelated or motor symptoms such as tremors, stiffness, slowness, and balance problems. Levodopa, a compound converted into dopamine in the brain, is still the gold standard therapy for Parkinson's, but as the disease advances this standard drug works for increasingly shorter time periods. As a result, patients begin to experience impaired movement before their next scheduled dose of medication. The re-emergence of symptoms accompanying this "off-time" can make it difficult for patients to perform even the most basic functions, such as walking and dressing. In addition, over time patients tend to develop a sensitivity to levodopa therapy during "on-time" resulting in involuntary twisting, turning movements known as dyskinesia. Currently available drugs widely used to treat Parkinson's disease correct for the loss of the neurotransmitter dopamine - either by boosting available dopamine in the brain or directly stimulating dopamine receptors. New ways to treat the disease that better address motor fluctuations without adverse side effects continue to be sought. Preladenant is a nondopaminergic medication that targets adenosine A2A receptors in the motor control areas of the brain. It may offer advantages over dopamine medications, possibly including fewer side effects.

The clinical trial was conducted at 44 sites in 15 countries. Preladenant is an investigational medicine and is not approved for use.
Source: University of South Florida (USF Health) Published on February 11, 2011 at 1:04 AM