Krasnik

Researchers are studying the long-term safety and tolerability of KarXT and KarX-EC in adolescents with schizophrenia and children and adolescents with autism-related irritability. This Phase 3, open-label study evaluates these treatments to better understand their effects over extended periods in these young populations. The trial is led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Participants receive KarXT as the study drug, with dosing specified on certain days. The study includes two groups adolescents aged 13 to 17 years with schizophrenia receiving KarXT alone, and children and adolescents aged 5 to 17 years with irritability associated with autism spectrum disorder receiving KarXT combined with KarX-EC. The treatment period extends up to 54 weeks, during which safety and tolerability are closely monitored. During the study, participants are regularly evaluated for treatment-emergent adverse events, serious adverse events, and adverse events of special interest. Additional assessments include monitoring for procholinergic and anticholinergic symptoms, suicidal ideation and behavior, and movement disorders using validated rating scales. The total participation duration spans up to 54 weeks, encompassing treatment and observation to track long-term effects and safety outcomes.

Researchers are evaluating the impact of the Accu-Chek SmartGuide continuous glucose monitoring CGM system compared with traditional self-monitoring of blood glucose SMBG in adults with Type 1 or insulin-dependent Type 2 diabetes who use multiple daily insulin injections. This open-label, randomized, multi-center clinical device study aims to see how the CGM system affects the time participants blood glucose levels stay within the target range of 70-180 mgdL. The study is sponsored by Hoffmann-La Roche and focuses on measuring blood glucose control improvements. Participants are assigned to one of two groups one uses the Accu-Chek SmartGuide CGM solution, which includes a sensor applicator and smartphone apps providing real-time glucose data and analysis the other group continues standard care with SMBG devices while wearing a blinded CGM sensor intermittently during assessment periods. The blinded sensors record data without providing feedback to participants. The study includes baseline, assessment periods A, B, and C occurring over several weeks to compare glucose control over time. During the study, participants will have their blood glucose monitored continuously or through SMBG devices, complete questionnaires on diabetes distress and fear of hypoglycemia, and have laboratory tests including HbA1c at multiple time points. Researchers will track various glucose metrics such as time in range, hypoglycemia events, and glycemic variability. The study duration extends through several assessment periods up to approximately 26 weeks, with ongoing evaluations to assess the usability and impact of the CGM system on diabetes management.

Researchers are evaluating the effects of intravenous ferric carboxymaltose FCM compared with a placebo on death risk, heart failure events, NT-proBNP levels, and quality of life in patients who recently had an acute myocardial infarction AMI and have iron deficiency. This phase 4, multicenter, randomized, double-blind, placebo-controlled clinical trial aims to assess these outcomes over a follow-up period ranging from 8 to 36 months. Participants are randomly assigned to receive either an intravenous 15-minute infusion of 1000 mg FCM diluted in saline or a placebo infusion of saline alone. The first dose is given on the day of randomization, with follow-up visits at 4, 8, 12, 18, 24, and 30 months to reassess participants and possibly repeat treatment if safety criteria are met. During the study, participants undergo evaluations including monitoring of death rates, heart failure events such as unplanned hospitalizations or emergency visits, changes in NT-proBNP concentration, and quality of life measured by the EQ-5D questionnaire. Safety and treatment effects are tracked throughout the follow-up period, which can last up to 36 months from the start of participation.