Continuous Subcutaneous Levodopa Delivery for Parkinson’s Disease: A Randomized Study

Autor:	Shir Fuchs Orenbach, Werner Poewe, Ryan Case, Sheila Oren, Fabrizio Stocchi, Aaron Ellenbogen, Tami Yardeni, Alberto J. Espay, Liat Adar, Mika Leinonen, C. Warren Olanow
Jazyk:	angličtina
Rok vydání:	2021
Předmět:	0301 basic medicine Research Report Male Levodopa Dyskinesia Drug-Induced Parkinson's disease Population Severity of Illness Index law.invention subcutaneous levodopa infusion Antiparkinson Agents 03 medical and health sciences Cellular and Molecular Neuroscience 0302 clinical medicine Randomized controlled trial law Outcome Assessment Health Care Clinical endpoint Medicine Humans Infusions Parenteral Single-Blind Method Adverse effect education Aged ND0612 education.field_of_study business.industry Carbidopa Parkinson Disease Middle Aged medicine.disease Motor fluctuations Drug Combinations 030104 developmental biology Dyskinesia Anesthesia Parkinson’s disease Feasibility Studies Female Neurology (clinical) medicine.symptom business 030217 neurology & neurosurgery medicine.drug
Zdroj:	Journal of Parkinson's Disease
ISSN:	1877-718X 1877-7171
Popis:	Background: ND0612 is a continuous, subcutaneous levodopa/carbidopa delivery system in development for patients with Parkinson’s disease (PD) experiencing motor fluctuations Objective: Evaluate the efficacy and safety of two ND0612 dosing regimens in patients with PD. Methods: This was a 28-day open-label study (NCT02577523) in PD patients with ≥2.5 hours/day of OFF time despite optimized treatment. Patients were randomized to treatment with either a 24-hour infusion (levodopa/carbidopa dose of 720/90 mg) or a 14-hour ‘waking-day’ infusion (levodopa/carbidopa dose of 538/68 mg plus a morning oral dose of 150/15 mg). Supplemental oral doses of levodopa were permitted for patients in both groups if required. In-clinic assessments of OFF time (primary endpoint) and ON time with or without dyskinesia were determined by a blinded rater over 8 hours (normalized to 16 hours). Results: A total of 38 patients were randomized and 33 (87%) completed the study. Compared to baseline, OFF time for the overall population was reduced by a least squares (LS) mean[95% CI] of 2.0[– 3.3, – 0.7] hours (p = 0.003). ON time with no/mild dyskinesia (no troublesome dyskinesia) was increased from baseline by a LS mean of 3.3[2.0, 4.6] hours (p
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2bc344a714dac14a6a201e6e49579834 http://europepmc.org/articles/PMC7990424 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
Nepřihlášeným uživatelům se plný text nezobrazuje	K zobrazení výsledku je třeba se přihlásit.