Active clinical trials for "Parkinson Disease"

This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone) and Duodopa (levodopa and carbidopa), in randomized order.

This is a single site, open-label study designed to examine dopamine transporter density using [123I]β-CIT SPECT imaging before and following treatment with IRX4204 for a 30-day period in early Parkinson's disease patients. In addition, clinical evaluations will be performed to evaluate the effect of IRX4204 treatment on the motor and cognitive symptoms of PD.

Many people with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD) have an underlying synucleinopathy, the most common of which are Parkinson's disease (PD) and Lewy body disease. Identifying additional abnormal clinical features may help in identifying those at greater risk of evolving to a more severe syndrome. Because gait disorders are common in the synucleinopathies, early abnormalities in gait in those with RBD could help in identifying those at increased risk of developing overt parkinsonism and/or cognitive impairment. The investigators aim to identify subtle gait abnormalities in idiopathic RBD and to identify sensitive and early biomarkers: to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and to track their evolution in the parallel with the disease progression. Main objective: In comparison with age and gender matched-controls, to identify in patients with RBD a larger reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task). Secondary objective: In comparison with age and gender matched-PD patients, to identify in patients with RBD a smaller reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task). In patients with RBD to identify correlations between the spatio-temporal characteristics modifications of gait between a single (gait) and a dual-task (gait+cognitive task) and the percentage of REM without atonia - the dopamine transporter (DAT) density using FP-CIT single-photon emission computed tomography; the reduction of the olfactory discrimination and thresholds. In patients with RBD to track the spatio-temporal characteristics evolution of gait over time (every 6 months for 2 years)

The purpose of a randomized, double-blind, placebo-controlled, 2-way crossover study is to evaluate the efficacy, safety/tolerability and pharmacokinetics of JM-010 for the treatment of subjects with Parkinson's Disease (PD) with levodopa-induced dyskinesia (LID).

Background and aim: Patients with Parkinson's disease (PD) exhibit disturbed manual dexterity. This impairment leads to difficulties in activities of daily living (ADL) such as buttoning a T-shirt or hand-writing. The aim of the present research project is to investigate the effectiveness of a high intensity home based exercise intervention focusing on fine motor skills (HOMEDEXT), in patients with PD. Design: A single blinded randomized controlled trial (RCT) will be performed. Randomization will be done by an independent biostatistician who will use a computerized randomization protocol. A baseline assessment and a follow-up measurement 4 weeks immediately after intervention (end of rehabilitation) will be performed. A follow-up measurement, 12 weeks later, will be done to assess long-lasting effects. Assessments will be performed by investigators who are blinded for the intervention. Participants: One hundred and four out-patients with PD will be recruited who report specific difficulties in manual dexterity when executing ADL. Intervention: The patients will be allocated to either an intervention group (n = 52) or control group (n = 52). In the intervention group PD patients will exercise, over a period of four weeks, once/day during 30 minutes a treatment with specific exercises for dexterity. The PD patients, who will be allocated to the control group, will exercise Theraband exercises. Outcome measures: The primary outcome measures for manual dexterity will be the Nine Hole Peg test. Secondary outcome measures will be the Coin Rotation task, a sensitive screening for dexterity. Furthermore for ADL a modified version of the subscale II of the Movement Disorders Society unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used. Parkinsonian symptoms will be assessed by the MDS-UPDRS subscale III. To assess improvements in quality of life a modified version of the Parkinson's Disease Questionnaire (PDQ-39) will be used.

The primary objective of this study is to investigate the effects of a theoretically driven, highly challenging exercise program (balance and strengthening exercises) in reducing fall rate, improving balance and reducing fear of falling in persons with Parkinson's disease. In this pilot, randomized, cross-over study, 32 participants with Parkinson disease will be randomly assigned to either an early start (immediately following enrollment) or late start (3 months after enrollment) multifactorial exercise program which will meet 2 times per week for 1.5 hours over 3 months. The exercise program will consist of balance and strengthening exercises which will be individualized depending on the ability of each participant. Fall rate, balance, walking ability, fear of falling, mood, anxiety, and quality of life will be measured prior to the start, at 3 months and 6 months after enrollment. Subjects will be enrolled for 6-7 months.

Study AFF011 is a randomized controlled parallel Group phase I study to investigate the safety and tolerability of two doses of the vaccine AFFITOPE® PD03A given to patients with early Parkinson's disease. In total 36 patients will be enrolled in 3 independent groups (2 treatment groups, 1 Placebo group), each consisting of 12 patients. The patients will be randomized to either receive 15µg or 75µg AFFITOPE® PD03A formulated with adjuvant or the reference substance without active component (Placebo). Over a study duration of 52 weeks, the study participants receive 4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks after the first injection. Male and female patients aged 45 to 70 years can participate in the trial. 2 study sites in Austria (Innsbruck and Vienna) will be involved. AFF011 is part of a project SYMPATH funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).

The proposed study will evaluate the safety, and initial efficacy of using the ExAblate Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD medications in subjects who are over 30 years of age and considered medication-refractory with advanced idiopathic Parkinson's disease (PD).

The primary objective of the trial was to investigate the efficacy of apomorphine continuous subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor fluctuations not well controlled on medical treatment. The secondary objective of the study was to investigate the safety and tolerability of apomorphine continuous subcutaneous therapy.

Gastroparesis (slow stomach emptying) is a common feature of Parkinson's Disease. Levodopa (Sinemet), a common medication for Parkinson's Disease, can make gastroparesis worse. Gastroparesis effects how the levodopa is absorbed and used by the body. This study will explore the possibility of using Erythromycin, a drug commonly used (off label) for gastroparesis, along with levodopa to determine if there is improved levodopa absorption and motor function.