Mecasin treatment in patients with amyotrophic lateral sclerosis: study protocol for a randomized controlled trial

Abstract

BackgroundAmyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that causes paralysis of limb, swallowing, and breathing muscles. Riluzole, the Food and Drug Administration-approved drug for ALS, provides minimal benefit, prolonging patient life by only 2–3 months. Previous studies have found a neuro-protective and anti-neuroinflammatory effect of Mecasin, with retrospective studies providing suggestive evidence for a beneficial effect of Mecasin. The aim of this study was to develop a protocol to determine the proper dosage of Mecasin.MethodsThis is a phase II-A, multi-center, randomized study with three arms. Thirty-six patients with ALS will be randomly assigned to one of three groups, each receiving the standard treatment with 100 mg of riluzole in addition to one of 1.6 g of Mecasin, 2.4 g of Mecasin, or a placebo. The Primary outcome is the Korean version of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised result after 12 weeks of treatment. Secondary outcomes include results of the Short Form Health Survey-8, Medical Research Council Scale, Visual Analogue Scale for Pain, Hamilton Rating Scale for Depression, Fatigue Severity Scale, Patient Global Impression of Change, pulmonary function test, forced expiratory volume in 1 s and its ratio to forced vital capacity, creatine kinase, and body weight. The frequencies of total adverse events and serious adverse events will be described and documented. The trial protocol has been approved by the Institutional Review Board of the Wonkwang University Gwangju and Sanbon Hospital (2016–5-4 and 2016–34-01, respectively). An Investigational New Drug status (30731) was granted by the Korea Food and Drug Administration.DiscussionThis trial will aim to identify the optimal dosage of Mecasin. Additionally, it will test the efficacy and safety of Mecasin in conjunction with standard treatment, riluzole, for alleviating the functional decline in patients with ALS.Trial registrationKorean National Clinical Trial Registry CRIS; KCT0001984. Registered on 28 July 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2557-z) contains supplementary material, which is available to authorized users.

Acetylcholinesterase Inhibitors in the Treatment of Neurodegenerative Diseases and the Role of Acetylcholinesterase in their Pathogenesis

“…In addition, the mixture of these herbs reduces microglia activation and proliferation. There are also registered clinical trials in patients with ALS who are taking a mixture of these herbs and the standard treatment received for ALS [435].…”

Tracking a Fast-Moving Disease: Longitudinal Markers, Monitoring, and Clinical Trial Endpoints in ALS

“…In clinical trials, muscle strength is often estimated by handheld dynamometry (HHD) ( 134 ), manual muscle testing (MMT) ( 105 ), scoring systems such as the Medical Research Council (MRC) Scale for muscle strength ( 135 ) and some studies also report limb circumference ( 136 ). Respiratory function in ALS is typically monitored by sniff nasal inspiratory pressure (SNIP), SVC, or FVC in addition to measures such as early morning arterial blood gas (ABG) and overnight pulse-oximetry ( 137 , 138 ).…”

The impact of ankle kinesio taping on pain management in patients with acute ankle sprain

“…These include the modulation of muscle function, the enhancement of cutaneous proprioception, the facilitation of improved local circulation, and the support of precise joint positioning. [9,10] Furthermore, KT offers enhanced patient comfort compared to conventional rigid bandages, allowing for a broader range of joint motion due to its inherent elasticity. [11] While KT has been applied in the management of ankle injuries by sports physicians and practitioners of complementary medicine, its adoption into the standard practices of Emergency Physicians (EPs) has not yet occurred.…”