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Parkinson's Disease clinical trials

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NCT ID: NCT00367900 Completed - Parkinson's Disease Clinical Trials

Parkinson's Genes and Environment Study

Start date: August 21, 2006
Phase:
Study type: Observational

This study will examine the roles of diet, lifestyle, genes, and their possible interactions in the cause of Parkinson's disease, using information from the NIH-AARP Diet and Health Study. The NIH-AARP study was established in 1995 to examine the roles of diet and lifestyle in cancer. It included 567,169 AARP members 50 or older from California, Florida, North Carolina, Pennsylvania, New Jersey, Louisiana, and the Atlanta and Detroit metropolitan areas. In 1995, participants completed a comprehensive questionnaire on diet and a survey on demographics, medications, as well as a follow-up survey in 1996 with more detailed questions on lifestyle and medications, as well as cooking methods and early life dietary habits. A third followup survey is currently underway. The current NIH-AARP substudy on Parkinson's disease will include approximately 9,000 participants from the NIH-AARP study - 3,000 of whom reported being diagnosed with Parkinson's disease on the most recent survey, and 6,000 control subjects. These study participants provide two saliva samples for genetic analysis and may be asked to complete a telephone interview. In addition, those with Parkinson's disease are asked permission to review medical information regarding their diagnosis.

NCT ID: NCT00363727 Completed - Parkinson Disease Clinical Trials

Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's

Start date: December 2003
Phase: Phase 3
Study type: Interventional

This study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with Parkinson's Disease who have been taking levodopa for less than 2 years.

NCT ID: NCT00361205 Completed - Parkinson's Disease Clinical Trials

Electronic Compliance Monitoring in Parkinson's Disease

Start date: November 2003
Phase: N/A
Study type: Interventional

Patients with Parkinson's Disease (PD) depend on medication for relief of motor symptoms, and for this reason are often assumed to medicate very carefully. Overall, medication adherence is very good, but a subset of 15 to 20% of cases take less than 80% of the total prescribed dose. However, irregular timing of drug ingestion is almost universal, perhaps contributed by fluctuating symptoms and drug regimen complexity. Pulsatile dopaminergic stimulation in the basal ganglia is implicated in the development and manifestation of motor complications of advancing PD. Irregular medication intake is likely to contribute to peaks and troughs in serum and brain drug levels. In other diseases, patient adherence to prescribed medication improves through simplifying drug regimens, providing additional education, counselling and behavioural approaches and providing reminder packaging. We tested the effect on the timing of medicine ingestion of an educational approach, in which patients were given detailed additional information about the continuous dopaminergic theory.

NCT ID: NCT00360633 Completed - Parkinson's Disease Clinical Trials

Psychiatric and Cognitive Manifestations of Parkinson's Disease

Start date: June 2006
Phase:
Study type: Observational

Parkinson's Disease (PD) is often thought of as affecting movement only. In fact, most patients also experience psychiatric and cognitive symptoms, sometimes from the disease itself, and sometimes as a side-effect of PD medications. The goals of this study are to evaluate the causes, effects, and clinical correlates of psychiatric and cognitive symptoms in PD.

NCT ID: NCT00360568 Completed - Parkinson's Disease Clinical Trials

Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

Start date: June 2009
Phase: Phase 3
Study type: Interventional

Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.

NCT ID: NCT00360412 Terminated - Parkinson's Disease Clinical Trials

A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

Start date: October 2006
Phase: Phase 3
Study type: Interventional

Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase, lasting 4 weeks (weeks 0-3) followed by the Maintenance Phase, lasting 52 weeks (weeks 4-56). All patients will receive active study drug. During the Titration Phase, patients will receive E2007 2 mg once daily (o.d.) for 2 weeks followed by 4 mg o.d. for 2 weeks. During the Maintenance Phase, patients will receive 4 mg o.d. Patients not tolerating the study drug at 4 mg, will be allowed to down titrate to 2 mg. Patients not tolerating 2 mg will be withdrawn from the study. Patients will have visits at 2, 4, 8, 20, 32, 44, and 56 weeks after study entry. In addition, a follow-up visit will occur 4 weeks after study treatment has ended (week 60). A home diary will be completed in which patients rate themselves as either: 1. OFF 2. ON without dyskinesia 3. ON with non-troublesome dyskinesias 4. ON with troublesome dyskinesias 5. Asleep These entries will be completed every half hour during the waking day and will be completed for 3 consecutive days following the visits at weeks 4, 8, 20, 32 and 44, and three days prior to the visits at weeks 56 and 60. At entry into the study (week 0) and at weeks 8, 20, 32, 44 and 56, the Unified Parkinson's Disease Rating Scale (UPDRS), Clinician's Global Impression of Change (CGIC) and Clinical Global Impression of Tolerance (CGIT) will be performed.

NCT ID: NCT00360308 Terminated - Parkinson's Disease Clinical Trials

Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

Start date: November 2006
Phase: Phase 3
Study type: Interventional

Randomised, double-blind, double dummy, parallel group design. Following the screening period patients will be randomised at the baseline visit, in a 1:1:1 manner, to one of three treatment arms; 4 mg E2007, 200 mg entacapone (with each dose of levodopa) or placebo. The first 4 weeks of the double blind phase will be used to titrate patients on the E2007 arm from 2 mg up to the maintenance dose of 4 mg. Patients randomised to entacapone or placebo will have dummy up titrations to maintain the blind. Following this titration phase, patients will remain on the maintenance dose for a further 14 weeks. Patients will have visits at 2, 4, 6, 10, 14 and 18 weeks after baseline. A follow up visit will be performed at Week 22. A home diary will be completed in which patients rate themselves as either: 1. "OFF" 2. "ON" without dyskinesias 3. "ON" with non-troublesome dyskinesias 4. "ON" with troublesome dyskinesias 5. Asleep These entries will be completed every 30 minutes during the waking day and will be completed for three consecutive days immediately prior to visits at Baseline, Weeks 6, 10, 18 and 22. At Baseline (Day 0), week 10 and 18 the Unified Parkinson's Disease Rating Scale (UPDRS - Parts I, II , III and IV) will be performed. At the end of the treatment period (Week 18), patients will undergo final efficacy and safety assessments and will stop taking the study medication they were receiving. They will be seen 4 weeks later for a follow up visit.

NCT ID: NCT00359723 Completed - Parkinson's Disease Clinical Trials

Methylphenidate and Parkinson's Disease

Start date: July 2004
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to determine if methylphenidate (MPD), a drug marketed in the U.S. to treat hyperactivity and narcolepsy, added to levodopa, will increase the beneficial effects of levodopa without bothersome side effects in people with Parkinson's disease (PD).

NCT ID: NCT00350402 Completed - Parkinson's Disease Clinical Trials

Masked Faces in Parkinson Disease: Mechanism and Treatment

Start date: December 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the effectiveness of high intensity respiratory muscle strength training in treating blunted facial expression in people with Parkinson disease.

NCT ID: NCT00346827 Completed - Parkinson's Disease Clinical Trials

Apomorphine Nasal Powder in the Treatment of Parkinson's Disease "Off" Periods.

Start date: July 2006
Phase: Phase 2/Phase 3
Study type: Interventional

To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in subjects with Parkinson's Disease.