Kendall

Researchers are evaluating the potential of GB-0895, an investigational drug, as an additional treatment for adolescents and adults with severe asthma that is not well controlled by inhaled corticosteroids and other common asthma medications. This global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of GB-0895 over one year, with an optional extension phase. The study includes participants aged 12 to 80 years with documented severe uncontrolled asthma despite current therapy. Participants will be randomly assigned to receive either GB-0895 or a placebo through subcutaneous injections every six months during the 52-week treatment period. The study also includes phases for screening and run-in before treatment, followed by a follow-up period lasting up to 38 weeks after treatment ends. An optional open-label extension allows participants to continue receiving GB-0895 at specified weeks after the initial treatment phase. During the study, participants will attend visits every 1 to 2 months after the first month to monitor health and treatment effects. Assessments include lung function tests, asthma symptom questionnaires, quality of life evaluations, and tracking of asthma exacerbations. Researchers will closely monitor safety and treatment responses through these evaluations and collect data on various health measures to understand the drugs impact on severe asthma over the course of the study.

Researchers are evaluating real-world treatment patterns, effectiveness, and side effects of xanomeline and trospium chloride KarXT in adults diagnosed with schizophrenia in the United States. The study aims to understand how these medications are used and their impact on patients, including treatment switches and titration over time. Participants diagnosed with schizophrenia who have started treatment with KarXT will be observed according to the product label for up to 20 weeks. The study includes those newly starting KarXT or switching from other antipsychotic treatments, with data collected on dosing changes, adverse events, symptom improvement, and treatment continuation. During the study, participants will undergo regular clinical assessments, including monitoring of weight, psychiatric symptoms using the Clinical Global Impressions - Improvement score, and recording any schizophrenia-related relapses or hospital visits. Researchers will track medication adherence, reasons for stopping treatment, and use of antiemetic medications for gastrointestinal symptoms, with baseline and follow-up data collected up to 20 weeks.

This research aims to compare the effects of two inhalers, budesonidealbuterol metered-dose inhaler BDA MDI and albuterol sulfate metered-dose inhaler AS MDI, both used as needed, in adolescents aged 12 to 17 years with asthma. The study focuses on their impact on the annual rate of severe asthma attacks in participants who have a documented diagnosis of asthma and at least one severe exacerbation in the past year. This is a randomized, double-blind, multicenter Phase IIIb trial. Participants are randomly assigned in equal numbers to receive either BDA MDI 160180 micrograms 2 puffs of 8090 micrograms or AS MDI 180 micrograms 2 puffs of 90 micrograms as needed, alongside their usual maintenance asthma therapy. The study includes a 7 to 28-day screening period, a 52-week treatment period, and a safety follow-up lasting 7 to 14 days after treatment ends. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered at a separate visit after safety follow-up. During the study, participants will be monitored through regular assessments including lung function tests such as peak expiratory flow, evaluation of asthma exacerbations, and safety checks for adverse events. The main outcome measured is the annualized rate of severe asthma exacerbations over the 52-week treatment. Safety follow-up and pharmacokinetic evaluations will further assess drug concentrations and participant well-being. Overall participation lasts from screening through safety monitoring after treatment completion.

Researchers are investigating treatments for patients who have experienced a deep brain bleed called intracerebral hemorrhage, a type of stroke caused by a blood vessel bursting inside the brain. This trial, named REACH, compares the usual medical care to an early, minimally invasive surgical procedure for removing the blood clot. The goal is to determine if this less invasive surgery improves recovery and outcomes compared to standard treatments, which may also include surgeries to relieve brain pressure. Participants are randomly assigned to one of two groups. One group receives surgical management involving a small skull opening to evacuate the clot within 24 hours of stroke symptom onset, performed by trained neurosurgeons following detailed clinical guidelines. The other group receives medical management according to established stroke care guidelines, including intensive care admission, blood pressure control, and treatments to prevent further bleeding or complications. Both groups follow specific clinical standardization guidelines tailored to their treatment. During the study, participants will be monitored closely with evaluations such as brain imaging and clinical scales. Researchers will assess outcomes like the modified Rankin Scale score 180 days after randomization to measure recovery, hospital mortality, changes in hematoma volume, adverse events, and duration of intensive care and mechanical ventilation. The study includes follow-up assessments up to six months, with ongoing safety and recovery monitoring throughout the hospital stay and after discharge.