This trial was a phase 2 placebo-controlled, double-blind, randomized, controlled trial in patients with acute ischemic stroke within 4. The primary objective of this trial was to examine the efficacy and safety of redasemtide. The incidence of adverse events was similar between the redacemtide group and the placebo group, confirming the favorable tolerability of redasemtide.
Redasemtide is a development-stage regeneration-inducing medicine that regenerates tissue damaged by injury or disease by administration of a drug without using living cells. Shionogi is advancing development of this compound in dystrophic epidermolysis bullosa, chronic liver disease, knee osteoarthritis and cardiomyopathy, in addition to acute ischemic stroke.
Initial unemployment claims unexpectedly jumped last week. The multi-center, double-blinded, randomized controlled trial enrolled subjects that were up to 10 years post-stroke with moderate to severe upper extremity impairment.
Subjects in the study were randomized to either the Paired VNS group intense physical therapy paired with active VNS or Control group intense physical therapy paired with sham VNS and did 6 weeks of in-clinic therapy followed by 3 months of home-based therapy. After in-clinic therapy, subjects in the Paired VNS group showed a 5.
After 3 months of home-based therapy, the number of participants achieving a clinically meaningful response in upper limb impairment after Paired VNS was approximately twice that of controls. The study showed that participants who received Paired VNS had clinically meaningful improvements in both motor impairment and function compared to controls.
In particular, the clinically meaningful response rate doubled with paired VNS for both impairment and functional outcomes. The safety of VNS implants has been well established in other clinical areas. We're excited by the prospect of safe and established surgical procedures that may help restore hand and arm function after stroke. Steve Cramer , Professor of Neurology at UCLA and Medical Director of Research at California Rehabilitation Institute in Los Angeles , observed, "Patients with chronic stroke have limited options for therapy, so it is encouraging to see these positive results in stroke patients up to 10 years post-stroke".
Stimulation of the vagus nerve triggers release of brain neuromodulators including acetylcholine and norepinephrine that strengthens motor circuits associated with movement, enabling the brain to effectively relearn the task. Efforts to obtain marketing authorizations from regulatory authorities in both the U. MicroTransponder, Inc. An experienced team of scientists and engineers has developed a neurostimulation technology platform to treat neurological conditions, including post-stroke motor rehabilitation and tinnitus.
MicroTransponder is rapidly expanding its team and seeks talented individuals with a passion for stroke rehabilitation and neuromodulation. MicroTransponder makes no claims that the investigational device is safe or effective.
Limited by Federal law to investigational use. The Oracle of Omaha knows how to beat inflation. So ride his coattails. Clinicians, patients and policymakers should reconsider interpretations and decisions regarding management of acute ischaemic stoke that were based on ECASS III results. Clinical Bottom Line: There have been only two randomized clinical trials to show benefit of systemic alteplase vs placebo in acute ischemic stroke.
After balancing for baseline differences in patients between the two groups, re-analysis of these two trial questions the validity and robustness of alteplase. Save my name, email, and website in this browser for the next time I comment. Time limit is exhausted. All rights reserved. Disclaimer Website by Innov8 Place. July 27, PMID: Clinical Question: Does removing confounders and effect modifiers in patients from the original NINDS trials change the outcomes of alteplase given within 3 hours of symptom onset for acute ischemic stroke?
However, when cumulative change in NIHSS score from baseline to 90 days are evaluated, much of the difference between tPA and placebo disappears, suggesting confounders in the above graph Distribution of baseline, 90d, and change in NIHSS by treatment At baseline, patients in the placebo group where more neurologically impaired compared to tPA group top panel.
Final outcomes were highly dependent on stroke severity This re-analysis shows that most patients who survive improve in neurologic status, regardless of treatment. This is not the case for patients with a baseline NIHSS value between roughly 5 and 22, where there is a trend toward better outcomes for tPA compared to placebo.
The reverse was true for patients with mild or more severe initial stroke scores. If the patients are starting with higher mRS i. After balancing for these two confounders: No statistical difference in treatment effect of tPA vs placebo in any of the outcomes There was an increase in symptomatic ICH with alteplase vs placebo Strengths: Applied 3 analytical approaches including multivariable modeling, matching, and stratified analysis to adjust for potential confounders Prespecified outcomes of clinical importance to avoid selective reporting Prespecified analytical methods to avoid selective analysis Limitations: Reanalysis is limited to the quality of the trial data from ECASS III Reanalysis cannot produce new conclusions but can only increase or decrease the certainty in the unadjusted analysis Discussion: The fragility index of the original ECASS III trial is 1 Only one patient would have to have a different outcome to change the study form positive to negative In the original ECASS III trial, baseline NIHSS score was lower in the alteplase group mean
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