Otrimed Clinical Research, Edgewood, New York, United States
Research Article
Safety and Efficacy of Novel Epidural Clonidine Micropellets for Lumbosacral Radiculopathy
Author(s): Nagy A Mekhail*, Ali R Rezai, Pragya B Gupta, W Porter McRoberts, Gregory J Fiore, Bryan A Jones, Lou-Anne G Acevedo-Moreno, Chris J Gilligan and Ramsin M Benyamin
Background: Chronic back and leg pain is a leading cause of disability and results in a significant health care expenditure. Options such as physical therapy, corticosteroids Epidural Injections (ESI) or spine surgery have limited long term benefit and may cause significant morbidity. Clonidine has anti-neuropathic pain and anti-inflammatory properties. A novel, slow-release biodegradable polymer (Poly (D, L-lactide) clonidine micropellets deliver sustained, high clonidine levels and may provide prolonged pain relief with minimal systemic side effects. Methods: A pilot multicenter investigation of the safety, pharmacokinetics (PK) and effectiveness of clonidine micropellets in patients with chronic lumbosacral radiculopathy. Three sequential cohorts of 18 subjects each received a single epidural injection of clonidine 0.325 mg, 0.975 mg or 1.95 mg (1, 3 or 6 micropellets, respectively.. Read More»
DOI:
10.37421/jcnn.2020.3.109
Journal of Clinical Neurology and Neurosurgery received 2 citations as per Google Scholar report