Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson’s Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study

Neurology and Therapy, Год журнала: 2023, Номер 12(6), С. 1937 - 1958

Опубликована: Авг. 26, 2023

Foslevodopa/foscarbidopa, a soluble formulation of levodopa/carbidopa (LD/CD) prodrugs for the treatment Parkinson's disease (PD), is administered as 24-hour/day continuous subcutaneous infusion (CSCI) with single site. The efficacy and safety foslevodopa/foscarbidopa versus oral immediate-release LD/CD was previously demonstrated in patients PD 12-week, randomized, double-blind, phase 3 trial (NCT04380142). We report results separate 52-week, open-label, registrational (NCT03781167) that evaluated safety/tolerability CSCI advanced PD. Male female levodopa-responsive ≥ 2.5 hours "Off" time/day received at individually optimized therapeutic doses (approximately 700–4250 mg LD per 24 hours) 52 weeks. primary endpoint safety/tolerability. Secondary endpoints included changes from baseline normalized "On" time, percentage reporting morning akinesia, Movement Disorder Society Unified Disease Rating Scale (MDS-UPDRS), Sleep Scale–2 (PDSS-2), 39-item Questionnaire (PDQ-39), EuroQol 5-dimension questionnaire (EQ-5D-5L). Of 244 enrolled patients, 107 discontinued, 137 completed treatment. Infusion site events were most common adverse (AEs). AEs mostly nonserious (25.8% reported serious AEs) mild/moderate severity. At week 52, time without troublesome dyskinesia improved (mean [standard deviation (SD)] change dyskinesia, 3.8 [3.3] hours; −3.5 [3.1] hours). experiencing akinesia dropped 77.7% to 27.8% 52. quality (PDSS-2) life (PDQ-39 EQ-5D-5L) also improved. Foslevodopa/foscarbidopa has potential provide safe efficacious, individualized, 24-hour/day, nonsurgical alternative ClinicalTrials.gov identifier NCT03781167.

Язык: Английский

---

Toward objective monitoring of Parkinson's disease motor symptoms using a wearable device: wearability and performance evaluation of PDMonitor®

Frontiers in Neurology, Год журнала: 2023, Номер 14

Опубликована: Май 16, 2023

Parkinson's disease (PD) is characterized by a variety of motor and non-motor symptoms. As progresses, fluctuations in the response to levodopa treatment may develop, along with emergence freezing gait (FoG) induced dyskinesia (LiD). The optimal management symptoms their complications, depends, principally, on consistent detection course, leading improved decisions. During last few years, wearable devices have started be used clinical practice for monitoring patients' PD-related symptoms, during daily activities. This work describes results 2 multi-site studies (PDNST001 PDNST002) designed validate performance wearability new device, PDMonitor®, For studies, 65 patients 28 healthy individuals (controls) were recruited. Specifically, Phase I first study, participants device 2-6 h clinic while neurologists assessed exhibited parkinsonian every half hour using Unified Disease Rating Scale (UPDRS) Part III, as well Abnormal Involuntary Movement (AIMS) severity assessment. goal was data gathering. On other hand, II second study (PDNST002), day-to-day variability evaluated, former control subjects latter. In both cases, number days, being unsupervised free perform any kind produced estimations majority fluctuations. Statistical analysis demonstrated that accuracy correlation between expert evaluations high. result, confirmed effectiveness system continuous telemonitoring solution, easy facilitate decision-making disease.

Язык: Английский

---

Assessing Eligibility for Apomorphine Therapy in Parkinson's Disease: The Telemonitoring Potential

Movement Disorders Clinical Practice, Год журнала: 2025, Номер unknown

Опубликована: Фев. 11, 2025

Abstract Background Although there are established guidelines for the selection of suitable candidates, objective and timely referral use apomorphine remains challenging. Objectives This research examined how telemonitoring may facilitate referrals continuous subcutaneous infusion in Parkinson's disease (PD). Methods A Blind Rater a multi‐disciplinary team (MDT) including an expert PD nurse, neurologist, geriatrician determined pump treatment eligibility 20 patients with PD. The MDT considered data physical examination to determine eligibility. used only (PDMonitor®) evaluate Results results show that using wearable sensors appropriateness is similar complete method combines motor symptom monitoring clinical evaluation. blind rater had 0.89 Cohen's kappa coefficient, which suggests high rate agreement. best‐performing metric differentiating who were recommended (APO) from those non‐recommended (non‐APO) therapy, was device‐reported percentage time “ON” state, takes into consideration “OFF” dyskinesia time. APO group lower values this could be differentiated non‐APO accurately (85%). Conclusions Using therapy might improve evaluation and, therefore help their quality life.

Язык: Английский

---

Outcomes of Focused Ultrasound Thalamotomy in Tremor Syndromes

Movement Disorders, Год журнала: 2023, Номер 39(1), С. 173 - 182

Опубликована: Ноя. 14, 2023

Abstract Background The current literature comparing outcomes after a unilateral magnetic resonance image–guided focused ultrasound (MRgFUS) thalamotomy between tremor syndromes is limited and remains possible preoperative factor that could help predict the long‐term outcomes. Objective aim was to report on different MRgFUS thalamotomy. Methods A total of 66 patients underwent for November 2018 May 2020 at St Vincent's Hospital Sydney. Each patient's syndrome classified prior treatment. Clinical assessments, including hand score (HTS) Quality Life in Essential Tremor Questionnaire (QUEST), were performed baseline predefined intervals 36 months. Results 63 patients, comprising 30 essential (ET), 24 dystonic (DT), 9 Parkinson's disease (PDT) returned least one follow‐up. In ET months there 61% improvement HTS 50% QUEST compared baseline. This comparison PDT where an initial benefit observed, which waned each follow‐up, remaining significant only up until 12 DT similar results observed patients: 43% Conclusion These support use treatment DT, appears have expected outcome diagnosed with ET. Patients should be warned risk failure. © 2023 Authors. Movement Disorders published by Wiley Periodicals LLC behalf International Parkinson Disorder Society.

Язык: Английский

---

Attitudes Toward the Adoption of Remote Patient Monitoring and Artificial Intelligence in Parkinson’s Disease Management: Perspectives of Patients and Neurologists

Patient, Год журнала: 2024, Номер 17(3), С. 275 - 285

Опубликована: Янв. 5, 2024

Early detection of Parkinson's Disease (PD) progression remains a challenge. As remote patient monitoring solutions (RMS) and artificial intelligence (AI) technologies emerge as potential aids for PD management, there's gap in understanding how end users view these technologies. This research explores neurologist perspectives on AI-assisted RMS.

Язык: Английский

---

Cognitive Outcomes of Advanced Therapies in Parkinson's Disease: A Systematic Review of Apomorphine and Levodopa–Carbidopa Intestinal Gel Therapies

European Journal of Neurology, Год журнала: 2025, Номер 32(2)

Опубликована: Фев. 1, 2025

ABSTRACT Background Parkinson's disease (PD) treatments, such as apomorphine (APO) and levodopa–carbidopa intestinal gel (LCIG), represent advanced therapeutic options for managing motor symptoms. However, clear selection criteria well‐defined cognitive outcomes are lacking. This systematic review specifically aimed to address these gaps by assessing the impact of APO LCIG in PD patients. Methods A was conducted following PRISMA guidelines, with searches PubMed, Web Science, Scopus, Embase. Two authors screened studies based on key inclusion criteria, including at least two tests, a follow‐up 6 months or more. The risk bias evaluated using Newcastle–Ottawa Scale (NOS). Results Fifteen were identified (7 8 LCIG). generally preserved function over 12‐month follow‐up, some decreases visuospatial memory executive functions. LCIG, 28‐month showed more extensive decline, particularly patients pre‐existing impairments. Variability tests made direct comparisons difficult. Discussion may have favorable profile than LCIG. differences duration, moderate bias, inconsistent assessments warrant cautious interpretation. Improved patient comprehensive evaluations recommended future practice.

Язык: Английский

---

The device-aided intrajejunal delivery of levodopa–entacapone–carbidopa intestinal gel the treatment of Parkinson’s disease: overview of efficacy and safety

Expert Review of Medical Devices, Год журнала: 2025, Номер unknown

Опубликована: Май 7, 2025

Device-aided therapies (DATs) have been developed to provide continuous drug delivery (CDD) people with advanced Parkinson's disease (PD) whose symptoms can no longer be effectively managed oral or transdermal therapy. Intrajejunal infusion of levodopa - carbidopa intestinal gel (LCIG), delivered via the CADD Legacy 1400 pump, is an established CDD option, while entacapone (LECIG), Crono LECIG a more recent addition range DAT options in Europe. This article explores rationale for development infusion, role formulation, and attributes specifications pump device. Clinical real-world data reporting its efficacy, safety tolerability PD patients from European centers are reviewed, focus on practical benefits that smaller, lighter quieter device who wish start treatment intrajejunal infusion. offers another valuable option consider suitable providing both good long-term clinical favorable experience patients.

Язык: Английский

---

Access to device-aided therapies in advanced Parkinson’s disease: navigating clinician biases, patient preference, and prognostic uncertainty

Journal of Neural Transmission, Год журнала: 2023, Номер 130(11), С. 1411 - 1432

Опубликована: Июль 12, 2023

Abstract Device-aided therapies (DAT), which include deep brain stimulation and pump-based continuous dopaminergic with either levodopa or apomorphine, are among the major advances in clinical management of Parkinson’s disease (PD). Although DAT being increasingly offered earlier course, their classical indication remains advanced PD. Theoretically, every patient should be transition to when faced refractory motor nonmotor fluctuations functional decline. Worldwide reality is far from these ideal, and, therefore, question “real-world” equal opportunity access for PD patients PD—even within a single health care system. Differences care, referral pattern (timing frequency), as well physician biases (unconscious/implicit conscious/explicit bias), patients’ preferences health-seeking behaviour considered. Compared DBS, little information available concerning infusion therapies, neurologists’ attitudes towards them. This viewpoint aims thought-provoking assist clinicians moving through process selection, by including decision algorithm own biases, perspective, ethical concerns current unknowns surrounding prognosis DAT-related long-term side effects given patient.

Язык: Английский

---

Infusion Therapies in the Treatment of Parkinson’s Disease

Journal of Parkinson s Disease, Год журнала: 2023, Номер 13(5), С. 641 - 657

Опубликована: Июнь 13, 2023

Oral levodopa is the gold-standard therapy for treating Parkinson’s disease (PD) but after a few years of treatment therapeutic window narrows, and patients often experience various treatment-related complications. Patients in this advanced PD stage may benefit from alternative therapy, such as continuous intrajejunal delivery levodopa-carbidopa intestinal gel (LCIG; or carbidopa-levodopa enteral suspension), levodopa-carbidopa-entacapone gel, subcutaneous apomorphine infusion. Consideration initiation infusion therapies are suggested before onset major disability. The present review summarizes clinical evidence management, discusses available screening tools PD, provides considerations around optimal use therapy.

Язык: Английский

---

Unilateral gamma knife thalamotomy for tremor safety and efficacy in multimodal assessment: a prospective case-control study with two-year follow-up

Neurologia i Neurochirurgia Polska, Год журнала: 2024, Номер 58(3), С. 283 - 291

Опубликована: Май 14, 2024

Unilateral gamma knife thalamotomy (GKT) is a treatment option for pharmacoresistant tremor of various aetiologies. There have been to date no randomised controlled trials performed assess its safety and efficacy. Our aim was summarise two-year multimodal observation patients with caused by Parkinson's Disease (PD) or essential (ET).

Язык: Английский

---