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Parkinson Disease clinical trials

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NCT ID: NCT02763800 Completed - Parkinson's Disease Clinical Trials

Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202

Start date: September 2000
Phase: Phase 1
Study type: Interventional

The objectives as stated in the study protocol were as follows: - To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202 (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male volunteers). Part A - To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA 3-202 in healthy young males. Part A - To investigate the safety and tolerability of a single multiple dose regimen (dose to be determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B - To characterise the steady state pharmacokinetic and pharmacodynamic profile of a single multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in healthy elderly volunteers. Part B

NCT ID: NCT02763787 Completed - Parkinson's Disease Clinical Trials

Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202

Start date: April 2000
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety and tolerability of single oral rising doses of BIA 3-202 up to 800 mg (proposed doses 10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg) in groups of 9 healthy male adult subjects, to characterise the preliminary pharmacokinetics of single rising oral doses of BIA 3-202 in healthy male adult subjects, to investigate the effects of single doses of BIA 3-202 on COMT activity in human erythrocytes and to investigate the effect of food on the pharmacokinetics of a single dose of BIA 3-202.

NCT ID: NCT02763137 Completed - Parkinson Disease Clinical Trials

Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients

LDCD-001
Start date: July 30, 2014
Phase: Phase 2
Study type: Interventional

This is a phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa (LD/CD) vs.semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson's disease (PD) who suffer motor fluctuations.The objective of this study is to assess the plasma pharmacokinetics (PK) of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD. For purposes of this study continuous intra-oral administration of LD/CD is defined as oral administration of LD/CD at 5-10 minute intervals. Secondary objectives are to assess the safety and tolerability of continuous intra-oral administration of LD/CD and the effect on PD motor function of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD.

NCT ID: NCT02761707 Completed - Parkinson's Disease Clinical Trials

Biomarkers in Neural Disorders

Start date: June 2016
Phase:
Study type: Observational

This study seeks to establish the sensitivity and specificity of what appears to be a unique brainstem biomarker of Parkinson's Disease (PD) - an electrically induced olygosynaptic nasotrigeminal reflex response - in differentiating early stage PD from normal controls and from patients with various other neurodegenerative diseases. This study will additionally compare the biomarker to olfactory testing.

NCT ID: NCT02756676 Completed - Parkinson Disease Clinical Trials

Impact of Rehabilitation in Quality of Life in PD

Start date: April 2015
Phase: N/A
Study type: Interventional

This study is aimed to evaluate the impact of an intensive, multidisciplinary rehabilitative program on quality of life in patients with Parkinson's Disease.

NCT ID: NCT02753621 Completed - Parkinson Disease Clinical Trials

Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease

Parkinsonics
Start date: December 1, 2015
Phase: Phase 2
Study type: Interventional

The overall objective of this study is to observe the effect of group Vocal performance training and performance experience on patients' reported symptoms and quality of life. The effectiveness of PD medications varies significantly in different patients depending on their symptoms. By using music-based interventions to improve symptoms that may be inadequately treated by medications, the investigators hope to improve quality of life in PD patients. "Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in Parkinson disease" (PD) is a controlled crossover behavioral intervention study of once weekly choral classes for patients with idiopathic PD (progressing toward a group performance) and once weekly discussion/support group meetings.

NCT ID: NCT02750982 Completed - Stroke Clinical Trials

Laughter Therapy Effects on Mood, Stress and Self-efficacy in People With Neurological Diseases.

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

This is a prospective investigation of the effects of Laughter therapy (LT) on perceived stress, self-efficacy, mood and other wellness measures in people with the following neurological conditions: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury, Huntington's Disease, multiple sclerosis, Parkinson's Disease, post-stroke, spinal cord injury.

NCT ID: NCT02749214 Completed - Parkinson's Disease Clinical Trials

Defining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes

Start date: February 2016
Phase:
Study type: Observational

The purpose of this study is to determine the potential for a Parkinson's Disease (PD) -specific breath signature as a non-invasive screening tool for identifying PD patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological disorders include any disorder involving the brain or the nervous system, for example memory disorders, stroke, movement disorders and many other conditions. The study will lay the foundation for future studies in which breath fingerprinting could be used as a screening technique. Investigators will also be looking at how the breath fingerprint correlates with inflammatory proteins in the blood.

NCT ID: NCT02744911 Completed - Parkinson Disease Clinical Trials

Development of Software to Provide the SpeechVive Device Via the Internet

Start date: January 26, 2018
Phase: N/A
Study type: Interventional

Telehealth, increasingly recognized in the neurology field as a solution to access issues for people with Parkinson's disease, improves access to speech therapy, particularly those living in rural areas or with travel barriers. The SpeechVive device, developed by SpeechVive, Inc., is a treatment solution that is easy to use and effective. In an NIH funded study, the SpeechVive device improved communication in 90% of individuals with PD by improving volume, articulation, and speech rate. The investigators propose to eliminate the one drawback of the SpeechVive device, namely that it currently must be programmed by a speech-language pathologist for each patient in person. The overall goal of this project is to develop a telehealth platform for the SpeechVive device that will enable video conferencing for treatment and remote programming of the SpeechVive device for each patient. Once the platform has been developed, the investigators will conduct a study to examine effectiveness and the patient and caregiver satisfaction with telepractice using the SpeechVive device.

NCT ID: NCT02741947 Completed - Parkinson Disease Clinical Trials

Levodopa Benserazide Generic Formulation Versus the Originator

FARM9X59Y4
Start date: April 2014
Phase: Phase 4
Study type: Interventional

The trial was an experimental two-centers, randomized, double-blind, two-sequence, non-inferiority cross-over study. Screened subjects already treated with Levodopa/Benserazide (LDB) (Madopar®) who agreed to participate in the study entered a 4 weeks period if not on stable regimen of Madopar® (run-in period). Following the run-in period, there were two maintenance periods of 4 weeks each, for a total duration of 8 weeks. Patients were assigned randomly (1:1) by a computerized randomization system to one of two formulation sequences maintaining the dose stabilized during the run in: - generic-originator - originator-generic At the end of maintenance period 1, the patients in each formulation group underwent an overnight switch to the same dose of the alternative formulation. The dose was kept stable during the whole length of trial. Clinical evaluations were performed at the end of each period. The tablets were encapsulated to maintain the blindness. A pharmacokinetic study with a fixed dose (100+25 mg) was performed in a sub-population of 14 subjects. Population: out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5 years, receiving L-dopa/benserazide. The total duration of the trial was approximately 8 weeks for patient divided in two maintenance periods of 4 weeks each.