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Parkinson Disease clinical trials

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NCT ID: NCT03105401 Terminated - Parkinson Disease Clinical Trials

Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease

HALLUPARK
Start date: May 15, 2017
Phase:
Study type: Observational

This study aims to describe hallucinations prevalence in a sample of patients affected by Parkinson's disease and consulting in an outpatient facility. An unique one hour interview will be offered to volunteers patients. Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics. The study hypothesis is that hallucinations prevalence in Parkinson's disease is underestimated and is higher than usually described in the scientific literature when all hallucinations modalities and minor hallucinatory phenomenons are searched for.

NCT ID: NCT03104725 Terminated - Parkinson Disease Clinical Trials

Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?

Start date: September 25, 2017
Phase: Phase 1
Study type: Interventional

Background: Parkinsons disease (PD) causes slow movement, stiffness, and poor balance. Many symptoms are due to the loss of brain cells that make the brain chemical dopamine. The cells may be damaged by the breakdown of dopamine by a process called oxidation. The drug N-acetylcysteine (NAC) can act as an antioxidant. Researchers want to test if NAC can decrease the oxidation of brain dopamine in people with PD. Objective: To look at the effect of NAC on brain chemistry in people with PD. Eligibility: People ages 18 and older with PD that were diagnosed within the past 5 years. They must be taking a monoamine oxidase inhibitor. Healthy volunteer participants ages 18 and older. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Participants will be hospitalized for 4 to 8 days. On day 1, participants will have blood and urine tests. For several hours, they cannot eat or drink anything but water and their medications. Late in the morning they will have a meal. About 2 hours later they will have a spinal tap (lumbar puncture). For this, a numbing medicine is injected into the back. A needle is inserted between the bones in the back to remove a small amount of fluid. The spinal tap may use x-rays to see inside the body. After the spinal tap, they will start taking NAC by mouth. They will take NAC twice a day for 2 more days. On the next day, they will not eat until a meal in the late morning. They will take a final NAC dose. About 2 hours later they will have a second spinal tap. Healthy Volunteer (HV) participants will receive a spinal tap on day one, followed by a second spinal tap 48 hours after the first spinal tap. HV participants will not receive NAC.

NCT ID: NCT03069911 Terminated - Depression Clinical Trials

Trial of OnabotulinumtoxinA for Depression in Parkinson Disease

Start date: November 1, 2018
Phase: Phase 1
Study type: Interventional

This study evaluates the efficacy of onabotulinumtoxinA (BOTOX®) in the treatment of depression associated with Idiopathic Parkinson Disease in adults. As a Randomized Controlled Trial, half of the participants will receive onabotulinumtoxinA injections and half will receive a placebo saline solution.

NCT ID: NCT03052712 Terminated - Stroke Clinical Trials

Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies

GREFEXII
Start date: September 9, 2016
Phase: N/A
Study type: Interventional

The role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic brain injury, stroke, focal lesions, has been recognized recently. Social cognition refers to a large group of emotional and cognitive abilities regulating inter-individuals relationships and it includes mainly theory of mind, emotional information processing and empathy. However, assessment of socio-emotional processes is still largely based on experimental tests that are not validated for clinical purpose. In addition their long duration of administration is not adapted to clinical examination. Finally these tests have not been standardized and normalized in French-speaking population.

NCT ID: NCT03051607 Terminated - Clinical trials for Idiopathic Parkinson Disease

Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.

Start date: April 10, 2017
Phase: Phase 3
Study type: Interventional

Phase 3, international, multicenter, open-label 12 month safety study.

NCT ID: NCT03034564 Terminated - Parkinson Disease Clinical Trials

A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease

Start date: January 2017
Phase: Phase 4
Study type: Interventional

This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization. Secondary outcomes are the PDQ-39, a 39-item self-report questionnaire assessing Parkinson's disease-specific health related quality over the last month in 8 different dimensions of function and well-being, and the Epworth Sleepiness Scale, a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep. There will be a screening visit (SC), baseline visit (BL), 2 clinic visits at 6 and 12 weeks (V01, V02), and telephone contact at 4 weeks and 8 weeks (T1, T2). In-person visits will include review of informed consent, concomitant medication review, adverse event review, pill counts, vital signs (including supine blood pressure), and outcome measurements. Telephone visits will include review of informed consent, concomitant medication review, and adverse event review.

NCT ID: NCT02924194 Terminated - Parkinson's Disease Clinical Trials

Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease

Start date: September 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation of the nucleus basalis of Meynert (also called the "nbM") at improving memory in Parkinson's disease patients with mild cognitive impairments and memory difficulties. Patients with Parkinson's disease (PD) that are eligible for Deep Brain Stimulation (DBS) therapy for improvement of their motor symptoms and with evidence of mild cognitive impairments and memory difficulties will be enrolled.

NCT ID: NCT02917122 Terminated - Depression Clinical Trials

The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease

Parkinson's
Start date: August 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Parkinson's disease (PD) is one of the most common neurological diseases manifested by movement disturbance. The concomitant psychiatric symptoms, especially depression, are often observed and have also great impact on patients' quality of life. The treatment of depressive symptoms in PD with antidepressants as the majority remains variable and inefficient, which complicates the disease prognosis. Transcranial direct current stimulation (tDCS) is a non-invasive brain modulation technique and has been demonstrated to improve psychiatric diseases such as major depression. In this study the investigators will assess the combined effects of tDCS on sertraline for the treatment of depression in PD. Ten sessions of tDCS in two weeks will be applied and the follow-up evaluation will continue bi-weekly for one month after completing all sessions. The efficacy of tDCS vs sertraline will be compared and evaluated with behavioral and cognitive outcome. In addition, the investigators will evaluate if the baseline dopaminergic activity in brain could predict the treatment outcome by using SPECT imaging. The investigators aim to establish the therapeutic parameters and safety criteria of tDCS as an add-on or alternative therapy, and further enhance the overall clinical efficacy in the treatment of depression in PD.

NCT ID: NCT02906020 Terminated - Parkinson's Disease Clinical Trials

A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation

MOVES-PD
Start date: December 15, 2016
Phase: Phase 2
Study type: Interventional

Primary Objectives: - Part 1: To determine the safety and tolerability of 4, 8, and 15 milligrams of GZ/SAR402671 (venglustat) administered orally for 4 weeks, as compared to placebo in participants with early-stage Parkinson's disease (PD) carrying a glucocerebrosidase gene (GBA) mutation or other pre-specified variants. - Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in participants with early-stage PD carrying a GBA mutation or other pre-specified variants. Secondary Objectives: Part 1: - To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR402671 in plasma when administered in early-stage PD participants carrying a GBA mutation. - To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in early-stage PD participants carrying a GBA mutation. Part 2: - To demonstrate overall safety and tolerability of GZ/SAR402671 administered orally for 52 weeks in early-stage PD participants carrying a GBA mutation as compared to placebo. - To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage PD participants carrying a GBA mutation over a 52-week period.

NCT ID: NCT02896816 Terminated - Parkinson Clinical Trials

EMG Modules as a Novel Biomarker of Basal Ganglia Plasticity in Parkinson's Disease

Start date: August 2016
Phase: N/A
Study type: Interventional

Study Purpose: Parkinson's disease leads to severally impaired motor control. The purpose of this study is to better understand and analyze the characteristics of arm muscle activity while doing some reaching tasks and of leg muscles while walking. This will allow the investigators to improve understanding of the mechanisms underlying the motor impairments in Parkinson's disease.