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Subcutaneous efgartigimod PH20 in generalized myasthenia gravis: A phase 3 randomized noninferiority study (ADAPT-SC) and interim analyses of a long-term open-label extension study (ADAPT-SC+).
Neurotherapeutics
September 2024
Department of Neuroimmunology and Neuromuscular Diseases, Fondazione Istituto Neurologico Carlo Besta, Milan, Italy.
ADAPT-SC (NCT04735432) was designed to evaluate noninferiority of subcutaneous (SC) efgartigimod PH20 to intravenous (IV) efgartigimod in participants with generalized myasthenia gravis (gMG). ADAPT-SC+ (NCT04818671) is an open-label extension study designed to assess long-term safety, tolerability, and efficacy of efgartigimod PH20 SC. Adult participants in ADAPT-SC were randomly assigned to receive a treatment cycle of 4 once-weekly administrations of efgartigimod PH20 SC 1000 mg or efgartigimod IV 10 mg/kg, followed by 7 weeks of follow-up.
View Article and Find Full Text PDFCoadministration of intravenous calcium along with neostigmine for rapid neuromuscular blockade recovery: A systematic review and meta-analysis.
J Anaesthesiol Clin Pharmacol
April 2023
Department of Anesthesiology and Critical Care, AIIMS, Bhubaneswar, Odisha, India.
Postoperative residual curarization (PORC) and the impact of the coadministration of intravenous calcium along with an acetylcholinesterase inhibitor on it are not well addressed. Extensive electronic database screening was done until October 7, 2022 after enlisting the protocol of this systematic review in PROSPERO (CRD42021274879). Randomized controlled trials (RCTs) evaluating the impact of intravenous calcium and neostigmine coadministration on neuromuscular recovery were included in this meta-analysis.
View Article and Find Full Text PDFEffect of coadministration of 10 mg/kg calcium chloride and neostigmine on extubation time: A randomized controlled trial.
Rev Esp Anestesiol Reanim (Engl Ed)
June 2024
Department of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Introduction And Objectives: Some studies investigating the effect of calcium on neostigmine-induced recovery of neuromuscular blockade have shown that this combination promotes neuromuscular recovery, but does not significantly affect the incidence of postoperative residual curarization and time to extubation. This study aimed to evaluate the effects of 10 mg/kg calcium chloride co-administered with neostigmine on early recovery and time to extubation.
Patients And Methods: This prospective, randomized, double-blinded, placebo-controlled study included 88 ASA I-II patients aged between 18 and 65 years who were scheduled for elective surgery lasting at least 1 h under general anaesthesia in which 10 mg/kg of calcium chloride or the same volume of normal saline was co-administered with 5 μg/kg of neostigmine at the end of surgery.
Evaluation and Application of a PET Tracer in Preclinical and Phase 1 Studies to Determine the Brain Biodistribution of Minzasolmin (UCB0599).
Mol Imaging Biol
April 2024
UCB Pharma, Braine L'Alleud, Belgium.
Purpose: Minzasolmin (UCB0599) is an orally administered, small molecule inhibitor of ASYN misfolding in development as a potential disease-modifying therapy for Parkinson's disease. Here we describe the preclinical development of a radiolabeled tracer and results from a phase 1 study using the tracer to investigate the brain distribution of minzasolmin.
Procedures: In the preclinical study, two radiolabeling positions were investigated on the S-enantiomer of minzasolmin (UCB2713): [C]methylamine UCB2713 ([C-N-CH]UCB2713) and [C]carbonyl UCB2713 ([C-CO]UCB2713).
Translatability of preclinical to early clinical tolerable and pharmacologically active dose ranges for central nervous system active drugs.
Transl Psychiatry
March 2023
Centre for Human Drug Research, Leiden, The Netherlands.
The primary purpose of this study was to assess the translatability of preclinical to early clinical tolerable and pharmacologically active dose ranges for central nervous system (CNS) active drugs. As a part of this, IBs were reviewed on reporting quality. Investigator's Brochures (IBs) of studies performed at the Centre for Human Drug Research (CHDR) reporting statistically significant results of CNS activity related to the drug's mechanism of action were included.
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