A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications
RecruitingThis is an observational study in which data are collected and studied from Parkinson's disease patients who have movement symptoms despite taking standard Parkinson's medications. In observational studies, observations are made without any changes to the participant's healthcare or treatment plan. No investigational product will be administered in this study, as participants will be treated with the standard of care that medical experts currently consider most appropriate. Parkinson's disease (PD) is a condition that affects the brain and causes problems with movement and other body functions. The symptoms of Parkinson's disease can worsen over time. People with Parkinson's disease may experience shaking (tremor), slow movements, stiff muscles, trouble walking, and problems with balance. They can also have other symptoms, such as difficulty thinking clearly, changes in mood, or difficulty sleeping. Parkinson's disease mostly affects older adults, but it can happen to younger people too. There is no cure, but treatments can help manage the symptoms and improve quality of life. While doctors and researchers know that Parkinson's disease affects people in different ways and can worsen over time, there are still many things they don't fully understand-especially for people who experience movement symptoms despite taking their usual Parkinson's medicines. Earlier studies did not follow these patients long enough or collect all the important information needed. This study is being done to fill those gaps. The main purpose of this study is to better understand how Parkinson's disease changes over time in patients who experience movement symptoms while taking standard oral Parkinson's medications, what challenges patients and their care partners face, and how their treatments are working in real life. To do this, researchers will collect data on: * Sociodemographics (e.g. age, gender, race/ethnicity, insurance provider). * Medical history and vital signs (e.g. comorbidities, family history of Parkinson's, height, weight, blood pressure). * Medications and treatments (e.g. Parkinson's and non-Parkinson's medications and other treatments, rehabilitation therapy sessions, use of mobility assistance devices). * Movement symptoms (e.g. tremor, slow movement, balance). * Non-movement symptoms (e.g. cognition, mood, sleep, activities of daily living). * Molecular data (e.g. genetics, α-synuclein). * Burden of care (e.g. economic cost). Data will come from questionnaires or rating scales conducted by the doctor with the patient during study visits, diaries and logs completed by the patient, medical records, health insurance claims records, blood samples and skin biopsies, a digital device that records movement/non-movement symptoms, and questionnaires completed by the care partner. Data will be collected from December 2025 to December 2032. Each participant may be followed for up to 5 years.
Phase—
TypeObservational
Age45 Years – 75 Years
WherePhoenix, Arizona, United States + 25 more
SponsorBayer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Cortical-Basal Ganglia Speech Networks
NCT04286308 ·
Parkinson Disease, Essential Tremor, Dystonia
RecruitingIn this research study the researchers want to learn more about brain activity related to speech perception and production.
PhaseNA
TypeInterventional
Age18 Years – 85 Years
WhereBoston, Massachusetts, United States
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
RecruitingThe purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
PhasePhase 3
TypeInterventional
Age50 Years – 85 Years
WhereBirmingham, Alabama, United States + 173 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
RecruitingThe objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.
PhasePhase 2
TypeInterventional
Age45 Years – 75 Years
WherePhoenix, Arizona, United States + 45 more
SponsorAskBio Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
NCT04165070 · Carcinoma, Non-Small-Cell Lung
RecruitingThe purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 45 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
RecruitingStudy BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).
PhasePhase 3
TypeInterventional
Age45 Years – 75 Years
WhereSun City, Arizona, United States + 41 more
SponsorBlueRock Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
RecruitingThe purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease. The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated. Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.
Phase—
TypeObservational
Age18 Years
WhereAliso Viejo, California, United States + 84 more
SponsorBoston Scientific Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease
RecruitingFreezing-of-gait (FoG) in Parkinson Disease (PD) is one of the most vivid and disturbing gait phenomena in neurology. Often described by patients as a feeling of "feet getting glued to the floor," FoG is formally defined as a "brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk." This debilitating gait phenomena is very common in PD, occurring in up to 80% of individuals with severe PD. When FoG arrests walking, serious consequences can occur such as loss of balance, falls, injurious events, consequent fear of falling, and increased hospitalization. Wearable robots are capable of augmenting spatiotemporal gait mechanics and are emerging as viable solutions for locomotor assistance in various neurological populations. For the proposed study, our goal is to understand how low force mechanical assistance from soft robotic apparel can best mitigate gait decline preceding a freezing episode and subsequent onset of FoG by improving spatial (e.g. stride length) and temporal features (e.g. stride time variability) of walking. We hypothesize that the ongoing gait-preserving effects can essentially minimize the accumulation of motor errors that lead to FoG. Importantly, the autonomous assistance provided by the wearable robot circumvents the need for cognitive or attentional resources, thereby minimizing risks for overloading the cognitive systems -- a known trigger for FoG, thus enhancing the repeatability and robustness of FoG-preventing effects.
PhaseNA
TypeInterventional
Age18 Years – 90 Years
WhereAllston, Massachusetts, United States + 1 more
SponsorHarvard Medical School (HMS and HSDM)
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
RecruitingThe goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.
PhasePhase 2
TypeInterventional
Age40 Years – 80 Years
WhereSun City, Arizona, United States + 69 more
SponsorNeuron23 Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Validation of DystoniaNet Deep Learning Platform for Diagnosis of Isolated Dystonia
NCT05317390 · Dystonia, Drug Induced Dystonia,
Parkinson Disease RecruitingThis research involves retrospective and prospective studies for clinical validation of a DystoniaNet deep learning platform for the diagnosis of isolated dystonia.
PhaseNA
TypeInterventional
AgeAny
WhereBoston, Massachusetts, United States
SponsorMassachusetts Eye and Ear Infirmary
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations
RecruitingThis is a Phase 2 study in people with Parkinson's disease who experience motor fluctuations while taking levodopa. The study will evaluate how effective two different doses of the study drug AP-472 are when added to levodopa treatment, compared with a placebo. The study will last about 12 weeks. Participants will be randomly assigned to receive one of the two doses of AP-472 or a placebo. Neither the participants nor the study staff will know which treatment is given. The study includes a screening period, a 4-week period during which Parkinson's medications must remain stable, and an 8-week treatment period. During the treatment period, limited adjustments to levodopa are allowed if needed.
PhasePhase 2
TypeInterventional
Age30 Years – 80 Years
WhereLittle Rock, Arkansas, United States + 24 more
SponsorAppello Pharmaceuticals, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Dance and Energy Expenditure Among Adults With Parkinson's
RecruitingThe first purpose of the study is to develop and test new methods for quantifying dance among adults with a diagnosis of Parkinson's using various kinds of cameras, wearable activity monitors, and questionnaires. The second reason we are conducting the study is to better understand the relationship between the intensity of dance classes specifically designed for adults with Parkinson's and individual-level factors like the kinds of routine activities one does beyond dancing and one's health status. Participants in the study may be asked to engage in any of the following activities: * complete a small number of assessments on their physical and cognitive functioning * complete their routine group-based dance classes, specifically designed for adults with a diagnosis of Parkinson's, while being recorded Depending upon the group that a participant joins, one may also be asked to: * wear an activity monitor on their waist while engaged in their daily business as usual for nine (9) days * complete an iDXA scan * describe their perceptions on how the use of technology can integrated into their dancing
PhaseNA
TypeInterventional
Age18 Years – 85 Years
WhereBoston, Massachusetts, United States
SponsorNortheastern University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease
RecruitingThe objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.
Phase—
TypeObservational
Age30 Years – 99 Years
WhereMiami, Florida, United States + 7 more
SponsorInSightec
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)
NCT06952504 · Endometrial Cancer
RecruitingResearchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. * EC is a type of cancer that starts in the tissues inside the uterus (womb) * pMMR indicates that certain normal proteins are present in the cancer cells * Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery * Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.
PhasePhase 3
TypeInterventional
Age18 Years
WhereMobile, Alabama, United States + 252 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Abbott DBS Post-Market Study of Outcomes for Indications Over Time
NCT04071847 · Movement Disorders,
Parkinson Disease, Essential Tremor
RecruitingThe purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.
Phase—
TypeObservational
AgeAny
WhereTucson, Arizona, United States + 47 more
SponsorAbbott Medical Devices
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
RecruitingA study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease. The study will consist of a 48-week double-blind treatment phase followed by a 48-week open-label phase.
PhasePhase 2 / Phase 3
TypeInterventional
Age40 Years – 80 Years
WhereBirmingham, Alabama, United States + 14 more
SponsorBiohaven Therapeutics Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
NCT06312176 · Breast Neoplasms
RecruitingThe purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
PhasePhase 3
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 258 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
NCT07002034 · Adjustment Disorder
RecruitingThe purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.
PhasePhase 2
TypeInterventional
Age18 Years – 80 Years
WhereBirmingham, Alabama, United States + 29 more
SponsorReunion Neuroscience Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer
NCT06989112 · Endometrial Cancer
RecruitingDESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.
PhasePhase 3
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 249 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
RecruitingThe Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.
Phase—
TypeObservational
Age30 Years
WhereBirmingham, Alabama, United States + 49 more
SponsorMichael J. Fox Foundation for Parkinson's Research
▾Tap for detailsClick for full details — eligibility, all locations, contacts