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Parkinson Disease clinical trials

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NCT ID: NCT02153645 Terminated - Parkinson's Disease Clinical Trials

Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.

ALLAY-LID-I
Start date: August 18, 2014
Phase: Phase 3
Study type: Interventional

This study was terminated early due to slow enrollment with 87 of 162 planned subjects enrolled. The purpose of this multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

NCT ID: NCT02153632 Terminated - Parkinson's Disease Clinical Trials

Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID

ALLAY-LID-II
Start date: July 30, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

NCT ID: NCT02113189 Terminated - Parkinson's Disease Clinical Trials

Impact of Walking Practice on Persons With PD

Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the impact of a specifically designed leg brace on walking endurance in individuals with Parkinson's disease.

NCT ID: NCT02103465 Terminated - Parkinson's Disease Clinical Trials

Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease

PARROT
Start date: December 2013
Phase: Phase 2
Study type: Interventional

This exploratory trial will fulfill a medical data gap for the dopamine-agonist rotigotine, as so far no data on elderly population is available. Primary objective: To assess efficacy and safety of rotigotine in patients with late onset Parkinson's Disease (PD), starting at age 70 or later, on motor symptoms. Secondary objective: To assess efficacy and safety of rotigotine in patients with late onset Parkinson's Disease (PD), starting at age 70 or later, on selected non motor symptoms : sleep quality; depression; cognitive function. Subjects ≥70 years, with diagnosis of Parkinson's Disease (PD) based on the presence of at least two of three cardinal features (bradykinesia, resting tremor, rigidity), within 12 months since diagnosis and no longer than 12 months from onset to diagnosis, and for whom the caring physician is uncertain on whether or not to start treatment. Outcome Measurement: Percentage of Responders to treatment in motor (part III) and Activities of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale (UPDRS) at visit 4 and 6; Percentage of Responders to treatment in sleep quality in relation to Parkinson's Disease Sleep Scale (PDSS)-2 at visit 4 and 6; Responders to treatment in mood in relation to Geriatric Depression Scale (GDS) at visit 4 and 6. Exploratory, randomized, double blind, placebo-controlled study: 80 patients with late onset Parkinson's Disease (PD) are randomized in 2 parallel groups, ratio 1:1. One group will be treated with rotigotine and one group will be treated with placebo, for 12 weeks after titration.

NCT ID: NCT02022735 Terminated - Parkinson's Disease Clinical Trials

Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease

Start date: September 1, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on walking in patients with Parkinson's disease that have had DBS. While DBS improves Parkinson's disease (PD) symptoms and walking in many patients in some of the patients walking problems persist. This study aims to find out what are the best stimulation parameters of the DBS in order to improve walking.

NCT ID: NCT01955616 Terminated - Parkinson's Disease Clinical Trials

A Phase 2 Study to Evaluate the Safety and Efficacy of RM-131 in Patients With Parkinson's Disease & Chronic Constipation

MOVE-PD
Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study, called MOVE-PD, is to investigate how individuals with Parkinson's disease (PD) and chronic constipation (CC) respond to RM-131 as compared to placebo. The study will look at how well RM-131 affects the frequency of spontaneous bowel movements over a 14-day period. The study will also evaluate the safety and tolerability of the study drug and evaluate whether the study drug relieves the uncomfortable GI symptoms related to chronic constipation in patients who are unsatisfied with other therapies they have tried for constipation.

NCT ID: NCT01950455 Terminated - Clinical trials for Parkinson's Syndrome

Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes

Start date: November 2013
Phase: Phase 3
Study type: Interventional

This is a phase 3, open-label, multiple-center, non-randomized single dose study to assess the safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of parkinsonian syndromes from non-parkinsonian tremor.

NCT ID: NCT01929317 Terminated - Parkinson Disease Clinical Trials

A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.

Start date: August 28, 2013
Phase: Phase 3
Study type: Interventional

This study is a Phase III, multicentre, randomized, initial double-blind study with subsequent open label phases. The study will havea screening phase (4 weeks), a dose increase effect verification phase (12 weeks), a down titration 1 phase (1 week), a long-term phase (39 weeks), down titration 2 phase (1 to 2 weeks) and a follow up phase. Subjects will be assigned to Ropinirole CR high-dose group or Ropinirole CR maintenance group at a ratio of 3:1. This study is being conducted to evaluate the efficacy (effect of increasing Ropinirole dose from 16 mg/day to 18-24 mg/day) of the Ropinirole CR tablets in early and advanced PD patients who have not achieved an optimal therapeutic response with marketed Ropinirole Immediate release (IR) (15 mg/day) or marketed Ropinirole CR (16 mg/day) formulations.

NCT ID: NCT01927055 Terminated - Parkinson's Disease Clinical Trials

A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy

Start date: November 2013
Phase: Phase 3
Study type: Interventional

Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.

NCT ID: NCT01905839 Terminated - Parkinson's Disease Clinical Trials

A Study of Movement Disorders Using the QMAT At-Home Testing Device

Start date: June 18, 2013
Phase:
Study type: Observational

Background: - Parkinson s disease (PD) affects half a million Americans, causing slow movements, tremors, stiffness, and trouble walking. Currently, these symptoms are measured by physical exam, but this is unreliable and requires an office visit. Researchers want to study a different way to measure PD symptoms, using a home-testing machine called a QMAT device. It can test how quickly someone moves doing different tasks. Researchers will study how this testing compares to physical exam testing and whether the device can detect changes in PD symptoms over time. Objectives: - To see if a home testing device can be used to evaluate Parkinson s disease symptoms. Eligibility: - Adults at least 18 years old with PD. Design: - Participants will have about 22 clinic visits over 5 years. Each visit will take up to 3 hours. Visits will be scheduled along with visits for another study. - At visit 1, participants will learn to use the QMAT device and how to send testing information to the clinic by computer. The device has a computer screen, some buttons, and some pegs. Participants will get a device to take home and any accessories. - Participants will learn 2 QMAT tests. For one, they will press keys as fast as possible. For the other, they will move pegs into holes. The tests will take a total of about 20 minutes. - Participants will take both tests at home, 2 times on the same day each week, once before their medication, once after. - A study coordinator will monitor the participant s computer data and discuss the at-home testing at the clinic visits.