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Parkinson Disease clinical trials

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NCT ID: NCT04990284 Active, not recruiting - Parkinson Disease Clinical Trials

eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.

ADOPTION
Start date: November 29, 2021
Phase: Phase 4
Study type: Interventional

This is a randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study in Parkinson's disease (PD) patients to evaluate the add-on efficacy of opicapone 50 mg or an extra dose of levodopa (L-DOPA) 100 mg as first strategy for the treatment of wearing-off.

NCT ID: NCT04986995 Active, not recruiting - Parkinson Disease Clinical Trials

OpicApone Sleep dISorder

OASIS
Start date: June 9, 2021
Phase: Phase 4
Study type: Interventional

The aim of this study is to To investigate in an exploratory manner the efficacy of 50 mg opicapone when administered with the existing treatment of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI), in Parkinson's disease (PD) patients with end-of-dose motor fluctuations and associated sleep disorders

NCT ID: NCT04978597 Active, not recruiting - Parkinson Clinical Trials

Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study)

EPSILON
Start date: May 31, 2021
Phase: Phase 3
Study type: Interventional

Opicapone (OPC) is a third generation catechol O methyltransferase (COMT) inhibitor (COMTi) developed by BIAL-Portela & Cª, S.A. It is approved as adjunctive therapy to preparations of L-DOPA/DDCI in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. Carbidopa and benserazide are both DDCIs used in association with L DOPA. When OPC is co administered with L DOPA/DDCI, peripheral COMT is inhibited and thus L DOPA plasma levels increase, increasing L DOPA bioavailability. The purpose of this Phase III study is to explore the potential of OPC to enhance the clinical benefit of L-DOPA in L DOPA treated patients in the early stages of Parkinson's Disease (PD) (patients without end-of-dose motor fluctuations, 'non fluctuators').

NCT ID: NCT04976959 Active, not recruiting - Parkinson Disease Clinical Trials

High Fiber in Parkinson's Disease

Start date: July 8, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the research is to determine the effects of a high-fiber nutritional supplement (HFS) on the bacteria, viruses, and fungi that live in different regions of the body in those with Parkinson's disease (PD). We will compare the bacteria, viruses, and fungi of those with PD to those without PD (healthy controls). We will also examine the effects of transplanting stool from humans into laboratory mice with or without Parkinson-like pathology to understand how the microbiome influences the brains of animals. We can use this information to get a better understanding of how changing the microbiome might help humans.

NCT ID: NCT04976127 Active, not recruiting - Parkinson Disease Clinical Trials

Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients

NEON
Start date: December 7, 2021
Phase: Phase 1
Study type: Interventional

This study is an open-label, single ascending dose escalation followed by a multiple administration dose at the maximal suitable dose (MSD). The investigational Medicinal Product (IMP) is given as an add-on therapy. Talineuren consists of GM1 (monosialotetrahexosylganglioside), the pharmacologically active ingredient, associated with a proprietary lipid formulation assembled as liposomes. The primary objective is to demonstrate the safety of TLN administration intravenously in Parkinson patients. Secondary objectives are the determination of the maximal suitable dose based on the safety profile and preliminary efficacy, as well as the determination of the pharmacokinetics (PK) profile.

NCT ID: NCT04956770 Active, not recruiting - Parkinson Disease Clinical Trials

Study on Feasibility of Targeted Epidural Spinal Stimulation (TESS) to Improve Mobility in Patients With Parkinson's Disease

STIMO-PARK
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

The purpose of the STIMO-PARKINSON study is to evaluate the safety and preliminary efficacy of Targeted Epidural Spinal Stimulation (TESS) system to induce modulation in leg muscle recruitment in patients with advanced Parkinson's disease, and its capacity to improve key gait and balance deficits when employed in the context of a rehabilitation process of 3 to 5 months.

NCT ID: NCT04922190 Active, not recruiting - Parkinson Disease Clinical Trials

Promoting Physical Activity Engagement for People With Early-mid Stage Parkinson's Disease (Engage-PD)

Engage-PD
Start date: March 15, 2020
Phase: Phase 1
Study type: Interventional

Engage-PD is a single cohort evaluation of implementation of a telehealth-delivered physical activity coaching program for people with early-mid stage Parkinson's disease. The program utilizes a physical or occupational therapist to provide one-on-one coaching for individuals with early-mid stage Parkinson's disease to provide individualized structured support to facilitate and optimize exercise uptake as part of an effective self-management program. The structure of the coaching program is based on previous research in neurodegenerative disease including Parkinson's disease and Huntington's disease.

NCT ID: NCT04904068 Active, not recruiting - Parkinson Disease Clinical Trials

Functional Neuroimaging in Parkinson's Disease

Start date: September 15, 2020
Phase:
Study type: Observational

The study uses magnetic resonance imaging (MRI) to better understand changes in the brain underlying motor symptoms affecting upper and lower limbs in Parkinson's disease.

NCT ID: NCT04802733 Active, not recruiting - Clinical trials for Advanced Parkinson's Disease

Phase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson's Disease

Start date: May 3, 2021
Phase: Phase 1
Study type: Interventional

This clinical trial is designed to test whether surgically injecting nerve cells that make dopamine into the brain of Parkinson's disease patients is safe, and to monitor for potential side effects.

NCT ID: NCT04783129 Active, not recruiting - Parkinson Disease Clinical Trials

Multidisciplinary Health Educational Program Based on Centered People Care Model in Parkinson's Disease

AMPARO
Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to compare the effects of two similar long-term interprofessional programs, one of them delivers by in-person classes, and another delivers by online classes on the quality of life of people with Parkinson's. Method: People with PD will be randomized into 3 groups: (1) Face-to-face group, in which participants, in groups of 10 persons, followed a multidisciplinary health education program composed of 10 monthly face-to-face lectures; (2) Remote group, in which individuals followed the same lectures delivered by online; and (3) Control group, in which participants followed no lecture. The participants will be evaluated before (BED) and after (ABP) the education program conclusion (10 lectures). Health quality of life was adopted as a primary outcome. Independence in daily living activities, motor and non-motor symptoms severity, and global cognitive capacity was adopted as secondary measures, Besides, all participants will be asked to answer a survey to evaluate the knowledge improvement of key learning points of lectures. The results will be analyzed by ANOVA for repeated measures.