Active clinical trials for "Parkinson Disease"

The purpose of this study is to evaluate the safety, efficacy of intra-putaminal infusion of AAV-hAADC-2 (adeno-associated virus encoding human aromatic L-amino acid decarboxylase) by stereotaxic surgery in patients with advanced Parkinson's disease.

Title: Evaluation of the tolerance and acceptability of Rasagiline in the treatment of early-stage Parkinson's disease. Type of study: Phase IV Study objectives: Principal objective: To evaluate the tolerance and acceptability of Rasagiline versus Pramipexole (dopamine agonist). Secondary objectives: To evaluate the clinical benefits of Rasagiline administered as a monotherapy in patients presenting with early-stage Parkinson's disease. Study design: Multicentre comparative randomised parallel-group double-blind study, with a total duration of fifteen weeks (three weeks of dose titration and twelve weeks of follow-up), comprising four evaluations (D0, W3, W9, W15). Number of patients: 240 patients (i.e. 120 in each group) presenting with early stage idiopathic Parkinson's disease. Number of centres: 70 neurologists distributed throughout three French regions Treatment studied: Rasagiline Presentation: 1 mg tablets Dosage : 1 mg/day in a single dose, in the morning at breakfast-time. Comparator: Pramipexole Presentation: 0.125 mg, 0.25 mg and 1 mg pramipexole dihydrochloride monohydrate tablets (corresponding respectively to 0.088 mg, 0.18 mg and 0.7 mg of pramipexole) Dose-titration: As specified in the SPC for pramipexole, the product will be administered in three daily doses, preferably with meals, and the treatment will begin with a dose-titration phase of three weeks' duration, during which time the dosage will be gradually increased. On completion of the dose-titration phase, the minimum therapeutic dose of 1.5 mg per day must be achieved by all the patients. The patients who cannot achieve this dosage will be withdrawn from the study. The reason for stopping dose-titration (and leaving the study) will be detailed in the CRF. Dosage: The effective dosage of pramipexole should be adapted to the individual, depending on clinical response and tolerance, in successive stages of 0.75 mg at one-week intervals, without exceeding the maximum dose of 3 mg per day. Treatment prohibited during the study : Pethidine, fluoxetine, fluvoxamine, dextromethorphan, or any other MAOI, sympathomimetics (including nasal and oral decongestants containing ephedrine or pseudoephedrine), anti-H2s (cimetidine, ranitidine). Principal evaluation criterion : The principal criterion of evaluation is the percentage of patients who have presented with at least one " significant " adverse event during follow-up. A significant adverse event is defined as : a severe adverse event (SAE) an adverse event which in the opinion of the investigator requires suspension of the treatment or reduction in dosage an adverse event considered as severe or moderate by the patient (AEs of which the intensity has not been evaluated will be considered as moderate to severe) Secondary evaluation criteria: analysis of adverse events in the total population analysis of adverse events by degree of severity analysis of adverse events in subject over 65 analysis of adverse events by symptom percentage of patients presenting with sleep problems (daytime drowsiness, narcolepsy, insomnia, fragmented sleep…) evaluation of Epworth Sleepiness Scale evaluation of quality of life (PDQ-8) evaluation of utilities by EuroQol (EQ-5D) overall clinical impression evaluated by the doctor (CGI-I) and by the patient (PGI-I) Global-Benefit-Risk (GBR) Evaluation of resources Analysis of the principal criterion: Analysis of the principal criterion will be carried out with those patients from the intention-to-treat population for whom tolerance data is available in at least one visit after D0. Comparative analysis The percentages of patients in the two treated groups who present with at least one significant adverse event will be compared using a Khi-2 test. Logistic regression A logistic regression analysis will be performed in order to explain the presence/absence of a significant event. The nature of the treatment and the centre will act as explanatory variables, and the initial scores as covariates. Analyses will also be performed on quantitative variables (ANCOVA) Evaluation of the Global Benefit-Risk (GBR) according to the model suggested by Chuang-Stein et al. Number of subject required: Calculation of the size is based on the hypothesis that the percentage of patients presenting with at least one significant adverse event during follow-up (principal evaluation criterion) will differ by 15% from one group to the other. With an alpha risk set at 5% and a beta ris kat 20%, the number of subjects required, calculated using the Casagrande et Pike formula, is 110 subjects per group. The NSN was slightly overestimated in order to maintain the desired strength while taking into account the possibility of lost to follow-up, and was fixed at 240 patients.

The purpose of this study is to determine the safety and efficacy of AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. This study involves the treatment of subjects with medically refractory Parkinson's disease (PD). The gene transfer product, a disabled virus with a gene called GAD, will be infused into the STN bilaterally using stereotactic surgical techniques. The overall goal of this approach is to normalize the activity of the STN and reduce the motor symptoms of PD. Because the change in UPDRS demonstrated a positive outcome, the sham surgery subjects from the blinded portion of the study will be invited to crossover into the Open-label Arm portion of the study. The Open-label Arm will further evaluate the safety and efficacy of AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain.

The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.

The purpose of the study is to explore the safety, tolerability and efficacy of Spheramine (cultured human retinal pigment epithelial cells on microcarriers) in Parkinson's Disease patients with advanced disease who have insufficient symptom control by optimum oral medication. Patients are randomized to receive Spheramine injections into both hemispheres or a sham surgical procedure in a ratio of 1:1. A three month pretreatment period must be completed prior to surgery. Time to endpoint is 24 months.

This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.

This study is a placebo-controlled, double-blind trial that will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease. The medication will be administered orally as 8 ounces of hydrogen-enriched drinking water twice a day over the course of one year.

This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS).

An inexpensive dual-task gait training protocol has been developed for people with PD namely game based treadmill platform. A feasibility randomized trial clinical trail will be conducted to evaluate the feasibility, acceptability and estimate treatment effect size of the treatment protocol to conduct a future RCT.

An extension study for participants who have completed a prior VY-AADC01 clinical study