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Parkinson's Disease clinical trials

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NCT ID: NCT00488657 Completed - Parkinson's Disease Clinical Trials

Improve Speech Using an In-the-ear Device in Parkinson's Disease

MJFFSpeech
Start date: June 2006
Phase: Phase 1
Study type: Interventional

This project will systematically examine the therapeutic effect of altered auditory feedback provided by the in-the-ear device on the speech impairments in patients with Parkinson's disease. Many patients with PD have difficulty starting their speech even though they know the words they want to say. They experience 'freezing' of the jaw, tongue and lips. When they eventually get their speech started, they have a hard time moving it forward. They keep on saying the same words or phrases over and over again while their voice gets softer and softer. Many words also run together. These symptoms make patients' speech very hard to understand and directly affect their care and quality of life. Currently, there is no effective medical or surgical treatment for these speech symptoms. We have tested an in-the-ear therapeutic device that provides altered auditory feedback in eight patients with PD and moderate to severe speech impairment and the results are encouraging. We will recruit 100 patients with PD and moderate to severe speech impairment for Phase A and 20 for Phase B of the study. They will use the device routinely to provide the altered auditory feedback as they speak to improve their speech intelligibility.

NCT ID: NCT00485069 Completed - Parkinson Disease Clinical Trials

REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study

Start date: June 2007
Phase: Phase 4
Study type: Interventional

Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006. ROP is expected to be used for a long term in clinical practice. However, no long-term clinical data with ROP administered three times daily are currently available from Japanese patients, and the clinical experience with ROP at >10mg/day is limited. For this reason, this study was designed as a multicenter open-label uncontrolled study. This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating Scale (UPDRS), Awake time spent "Off"/"On", Modified Hoehn & Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI)) and the long-term safety of ROP administered three times daily for in PD patients.

NCT ID: NCT00476372 Completed - Parkinson's Disease Clinical Trials

Cognitive Impairment in Parkinson's Disease Categorised in Accordance to Motor Symptoms

Start date: August 2007
Phase: N/A
Study type: Observational

Background: Approximately 40% of patients with Parkinson's disease (PD) have cognitive impairments. There is a lack of consensus as to the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the type and severity of cognitive impairment. This discrepancy can in part be caused by the lack of distinction between patients with different motor symptoms and disease severity. Objective: To identify the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the severity and type of cognitive dysfunction in patients with idiopathic PD categorized according to motor symptoms and disease severity. Methods: the population of patients with PD in the old county of Aarhus is described on the background of medical records, and stratified in accordance to age, sex and cardinal symptoms. Through proportional allocation a sample of a minimum of 50 patients with PD is drawn from the population. The patients and 30 healthy matched controls will undergo comprehensive neuropsychological assessment including tests of language, memory, executive function, and visuospatial function. Furthermore, all participants will be screened for depression (Geriatric Depression Scale) and psychiatric symptoms (Neuropsychiatric Inventory and Symptom Checklist). The patients will be categorized in accordance with their motor symptoms via cluster analysis for the purpose of analyzing the effect of psychiatric symptoms, depression, and age of disease onset, disease duration, and medication on cognition.

NCT ID: NCT00474058 Completed - Parkinson's Disease Clinical Trials

Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine

RECOVER
Start date: May 2007
Phase: Phase 3
Study type: Interventional

The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

NCT ID: NCT00468078 Completed - Parkinson's Disease Clinical Trials

Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients

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

The purpose of this study is to determine whether F-18 FPCIT is effective and safe radiopharmaceutical for the objective diagnosis of Parkinson's disease.

NCT ID: NCT00466739 Completed - Parkinson's Disease Clinical Trials

European Compliance Study in Parkinson's Disease

Start date: January 2006
Phase: Phase 3
Study type: Observational

In both symptomatic and asymptomatic disease, only about half of medicines are taken as prescribed1. Relatively little is known about how patients with Parkinson's disease take their medication. One of the challenges in the management of Parkinson's disease is the prevention and treatment of involuntary movements2,3 and wild fluctuations between being mobile and able to function against being slow, stiff and unable to move which recurs as a delayed (several years) effect of taking antiparkinson medication. One theory of why this occurs is that it is due to pulsatile rather than continuous delivery of medication to the brain4. If patients take their medicines erratically and irregularly, this causes more fluctuations in blood and therefore brain drug levels may prime patients for complications in the future. This project will define the extent of irregular medication taking in Parkinson's disease, examine associated clinical and demographic characteristics and examine the ease of adherence to different drug regimes. Knowledge of therapy adherence will help support patients in using their medicines to best effect. In the present document the terms compliance and adherence are used with equal meaning.

NCT ID: NCT00464464 Completed - Depression Clinical Trials

Coping With Depression in Parkinson's Disease

Start date: April 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of a cognitive-behavioral treatment, that includes a caregiver-focused social support intervention, for depression in persons with Parkinson's disease. Individuals who are unable to travel to the study site, but are interested in participating and meet all other eligibility requirements, will be allowed to participate over the phone.

NCT ID: NCT00462007 Completed - Parkinson's Disease Clinical Trials

Study to Evaluate Initiation of Stalevo in Early Wearing-off

SENSE
Start date: September 2006
Phase: Phase 4
Study type: Interventional

An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The study will consist of 2 consecutive periods: screening period and study treatment period. Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will be determined by the subject's current, separately administered standard levodopa/DDCI treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be switched to an equivalent dose of Stalevo® without changing the number of doses per day. The levodopa daily dose during Stalevo® treatment may be adjusted according to the study subject's clinical response.

NCT ID: NCT00461942 Completed - Parkinson's Disease Clinical Trials

Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients

Start date: April 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Green Tea Polyphenol, an extraction from Green Tea is effective and safe in the treatment of De Novo Parkinson's disease Patients without taking any antiparkinsonism drug

NCT ID: NCT00460954 Completed - Parkinson's Disease Clinical Trials

A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects

Start date: June 2007
Phase: N/A
Study type: Observational

The purpose of this clinical research study is to determine if different dosage regimens of Sinemet® CR (Carbidopa/levodopa) are dose proportional