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Opicapone (Ongentys) - To treat patients with Parkinson’sdisease experiencing “off” episodes Drug Approval Package: ONGENTYS U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: ONGENTYS Company: Neurocrine Biosciences, Inc. Application Number: 212489 Approval Date: 04/24/2020 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application Review
Personalized iPSC-Derived Dopamine Progenitor Cells for Parkinson'sDisease. We report the implantation of patient-derived midbrain dopaminergic progenitor cells, differentiated in vitro from autologous induced pluripotent stem cells (iPSCs), in a patient with idiopathic Parkinson'sdisease. The patient-specific progenitor cells were produced under Good Manufacturing Practice conditions and characterized as having the phenotypic properties of substantia nigra pars compacta neurons; testing (...) in a humanized mouse model (involving peripheral-blood mononuclear cells) indicated an absence of immunogenicity to these cells. The cells were implanted into the putamen (left hemisphere followed by right hemisphere, 6 months apart) of a patient with Parkinson'sdisease, without the need for immunosuppression. Positron-emission tomography with the use of fluorine-18-L-dihydroxyphenylalanine suggested graft survival. Clinical measures of symptoms of Parkinson'sdisease after surgery stabilized or improved
Isradipine Versus Placebo in Early ParkinsonDisease: A Randomized Trial. Studies suggest that dihydropyridine calcium-channel blockers may be associated with reduced risk for Parkinsondisease (PD).To assess the effect of isradipine, a dihydropyridine calcium-channel blocker, on the rate of clinical progression of PD.Multicenter, randomized, parallel-group, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT02168842).57 Parkinson Study Group sites in North America.Patients (...) with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment.5 mg of immediate-release isradipine twice daily or placebo for 36 months.The primary outcome was change in the Unified Parkinson'sDisease Rating Scale (UPDRS) parts I to III score measured in the antiparkinson medication "ON" state between baseline and 36 months. Secondary outcomes included time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor
Diagnosis and Treatment of ParkinsonDisease: A Review. Parkinsondisease is the most common form of parkinsonism, a group of neurological disorders with Parkinsondisease-like movement problems such as rigidity, slowness, and tremor. More than 6 million individuals worldwide have Parkinson disease.Diagnosis of Parkinsondisease is based on history and examination. History can include prodromal features (eg, rapid eye movement sleep behavior disorder, hyposmia, constipation), characteristic (...) movement difficulty (eg, tremor, stiffness, slowness), and psychological or cognitive problems (eg, cognitive decline, depression, anxiety). Examination typically demonstrates bradykinesia with tremor, rigidity, or both. Dopamine transporter single-photon emission computed tomography can improve the accuracy of diagnosis when the presence of parkinsonism is uncertain. Parkinsondisease has multiple disease variants with different prognoses. Individuals with a diffuse malignant subtype (9%-16
: Affiliations 1 Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Clintrex, Sarasota, FL, USA. Electronic address: firstname.lastname@example.org. 2 Department of Neurology, Emory University, Atlanta, GA, USA. 3 Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH, USA. 4 Department of Neurology, University of South Florida, Tampa, FL, USA. 5 Barrow Neurological Institute, Phoenix, AZ, USA. 6 Parkinson'sDisease and Movement Disorders (...) and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA. 7 University of Kansas Medical Center, University of Kansas, Kansas City, KS, USA. 8 Clintrex, Sarasota, FL, USA. 9 Sunovion, Marlborough, MA, USA. PMID: 31818699 DOI: Item in Clipboard Full-text links Cite Abstract Background: Many patients with Parkinson'sdisease have potentially disabling off episodes that are not predictably responsive to levodopa. In this study, we assessed the safety and efficacy of apomorphine sublingual film
Assessment of an Objective Method of Dyskinesia Measurement in Parkinson'sDisease. The goal of this study was to validate an objective method of measuring levodopa induced dyskinesia in Parkinson'sdisease (PD).To characterize agreement between the clinician-based measure and a force plate, we assessed dyskinesia in PD subjects participating in a randomized and blinded clinical trial of an adenosine A2A anatagonist. Convergent validity and intra-class correlations were evaluated between
Integrated Analysis of Droxidopa for the Treatment of Neurogenic Orthostatic Hypotension in Patients with ParkinsonDisease. Neurogenic orthostatic hypotension (nOH) is associated with neurodegenerative conditions, may cause symptoms of end-organ hypoperfusion, increases fall risk, and can negatively impact quality of life. Droxidopa is approved for the treatment of symptomatic nOH in adults. As the largest subpopulation of patients with nOH has a diagnosis of Parkinsondisease (PD
and Uncertainties Conclusions and Reasons Analysis of Condition ? The condition treated was advanced Parkinson'sdisease which is operationally defined as patients taking levodopa and experiencing OFF episodes. Istradefylline was given to these patients as adjunctive treatment. The pivotal trials were adequate for investigating effects on istradefylline on adult patients with advanced Parkinson'sdisease. Current Treatment Options ? There are many approved treatments as adjunctive therapy for patients (...) Istradefylline (Nourianz) - Parkinson'sdisease CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022075Orig1s000 CLINICAL REVIEW(S) (b) (4) Clinical Review Natalie Branagan, MD NDA 022075 Nourianz/istradefylline CLINICAL REVIEW Application Type NDA Application Number(s) 022075 Priority or Standard Class 2 Resubmission Submit Date(s) February 27, 2019 Received Date(s) February 27, 2019 PDUFA Goal Date August 27, 2019 Division/Office DNP Reviewer Name(s) Natalie Branagan, MD Review
of group assignments. Both interventions were home based, requiring 30-45 min training three times per week for 6 months. Both groups received a motivational app and remote supervision. Home trainers were enhanced with virtual reality software and real-life videos providing a so-called exergaming experience (ie, exercise enhanced by gamified elements). The primary outcome was the between-group difference in the Movement Disorders Society-Unified Parkinson'sDisease Rating Scale (MDS-UPDRS) motor (...) Effectiveness of home-based and remotely supervised aerobic exercise in Parkinson'sdisease: a double-blind, randomised controlled trial High-intensity aerobic exercise might attenuate the symptoms of Parkinson'sdisease, but high-quality evidence is scarce. Moreover, long-term adherence remains challenging. We aimed to evaluate the effectiveness of aerobic exercise-gamified and delivered at home, to promote adherence-on relieving motor symptoms in patients with Parkinson'sdisease with mild
with Parkinson’sdisease, the cells in the brain that produce dopamine, a neurotransmitter important for controlling movement, begin to die and the amount of dopamine in the brain decreases. Inbrija contains levodopa which converts into dopamine in the brain and helps to restore dopamine levels, thereby improving the symptoms of the condition. Because Inbrija is inhaled, it can supply extra levodopa (and hence dopamine) quickly when needed during an ‘off’ period. What benefits of Inbrija have been shown (...) malignant syndrome or rhabdomyolysis. For the full list of side effects and restrictions, see the package leaflet. Why is Inbrija authorised in the EU? Studies show that Inbrija is effective at reducing symptoms during ‘off’ periods in patients with Parkinson’sdisease on levodopa/dopa-decarboxylase-inhibitor treatment. The safety of the medicine is in line with other similar medicines. Because it is inhaled, Inbrija provides rapid relief of symptoms, which improves patients’ quality of life
and written form. n Discussions should aim to achieve a balance between providing realistic information and promoting optimism. n Families and caregivers should be informed about the condition and available support services. DIAGNOSIS AND PROGRESSION n Parkinsondisease should be suspected in anyone with tremor, stiness, slowness, balance problems or gait disorders. n CT or MRI brain scanning should not be routinely used to diagnose Parkinsondisease. n Patients, especially young, who request genetic (...) to achieve a balance between providing realistic information and promoting optimism. n Families and caregivers should be informed about the condition and available support services. DIAGNOSIS AND PROGRESSION n Parkinsondisease should be suspected in anyone with tremor, stiness, slowness, balance problems or gait disorders. n CT or MRI brain scanning should not be routinely used to diagnose Parkinsondisease. n Patients, especially young, who request genetic testing should be assessed by a movement
Safinamide (Xadago) for the treatment of adult patients with idiopathic Parkinson'sdisease Safinamide (Xadago®) for the treatment of adult patients with idiopathic Parkinson'sdisease | Report | National Health Care Institute You are here: Safinamide (Xadago®) for the treatment of adult patients with idiopathic Parkinson'sdisease Search within English part of National Health Care Institute Search Safinamide (Xadago®) for the treatment of adult patients with idiopathic Parkinson'sdisease
Safinamide (Onstryv) - idiopathic Parkinson'sdisease Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1
effect of land-based therapies plus aquatic therapy in patients with PD who have FOG.The objective was to investigate the effectiveness of a multidisciplinary, intensive, motor-cognitive rehabilitation treatment (MIRT) in improving FOG and whether implementation with aquatic therapy (MIRT-AT) adds further benefits.The design consisted of a single-blind, parallel-group, 1:1 allocation ratio, randomized trial.The Department of ParkinsonDisease, Movement Disorders and Brain Injury Rehabilitation (...) Land Plus Aquatic Therapy Versus Land-Based Rehabilitation Alone for the Treatment of Freezing of Gait in ParkinsonDisease: A Randomized Controlled Trial Freezing of gait (FOG) is one of the most disabling symptoms of Parkinsondisease (PD). Different land-based rehabilitation approaches based on motor and cognitive strategies can be effective in treating FOG. Although there are data about the efficacy of aquatic therapy in ameliorating this phenomenon, no study has explored the combined
Randomized trial of care management to improve Parkinsondisease care quality To test effects on care quality of Chronic Care Model-based Parkinsondisease (PD) management.This 2-group stratified randomized trial involved 328 veterans with PD in southwestern United States. Guided care management, led by PD nurses, was compared to usual care. Primary outcomes were adherence to 18 PD care quality indicators. Secondary outcomes were patient-centered outcome measures. Data sources were telephone (...) of the changes over time was in the positive Patient Health Questionnaire-2 depression screen for intervention minus usual care (-11.52 [95% CI -20.42, -2.62]).A nurse-led chronic care management intervention, Care Coordination for Health Promotion and Activities in Parkinson'sDisease (CHAPS), substantially increased adherence to PD quality of care indicators among veterans with PD, as documented in the EMR. Of 8 secondary outcomes assessed, a screening measure for depressive symptomatology was the only
Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With ParkinsonDisease: Randomized Controlled Pilot Study Declining physical activity commonly occurs in people with Parkinsondisease (PD) and contributes to reduced functional capacity and quality of life.The purpose of this study was to explore the preliminary effectiveness, safety, and acceptability of a mobile health (mHealth)-mediated exercise program designed to promote sustained physical (...) . Daily steps and moderate-intensity minutes were measured using a step activity monitor for 1 week at baseline and again at 12 months. Secondary outcomes included the 6-Minute Walk Test, ParkinsonDisease Questionnaire 39 mobility domain, safety, acceptability, and adherence.Both groups increased daily steps, moderate-intensity minutes, and 6-Minute Walk Test, with no statistically significant between-group differences observed. In the less active subgroup, changes in daily steps and moderate
Bright light therapy for depression in Parkinsondisease: A randomized controlled trial To assess the efficacy of bright light therapy (BLT) in reducing depressive symptoms in patients with Parkinsondisease (PD) and major depressive disorder (MDD) compared to a control light.In this double-blind controlled trial, we randomized patients with PD and MDD to treatment with BLT (±10,000 lux) or a control light (±200 lux). Participants were treated for 3 months, followed by a 6-month naturalistic
Trunk Exercises Improve Gait Symmetry in ParkinsonDisease: A Blind Phase II Randomized Controlled Trial. Deficits in step-to-step symmetry and trunk muscle activations have been linked to falls in Parkinsondisease. Given such symptoms are poorly managed with anti-parkinsonian medications, alternate therapies are needed. This blind phase II randomized controlled trial sought to establish whether exercise can improve step-to-step symmetry in Parkinson disease.Twenty-four Parkinsondisease (...) , active interventions seem more suited to increasing independence and quality of life for people with Parkinson disease.Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME CME OBJECTIVES: Upon completion of this article, the reader should be able to do the following: (1) Describe the effect deficits in trunk muscle function have on gait in individuals with Parkinsondisease; (2) Identify the benefits of targeted trunk exercises on step-to-step symmetry