Krasnik

Researchers are assessing the long-term safety and tolerability of two treatments, KarXT and KarX-EC, for adolescents with schizophrenia and children and adolescents with irritability related to autism spectrum disorder. This Phase 3, multicenter, open-label study includes participants aged 5 to 17 years and aims to monitor how these treatments are tolerated over time in these specific populations. Participants receive KarXT or a combination of KarXT and KarX-EC at specified doses on designated days. The study includes adolescents aged 13 to 17 years with schizophrenia and children and adolescents aged 5 to 17 years with autism-related irritability. Treatment is administered openly, meaning both researchers and participants know the treatment being given. Throughout the study, researchers will evaluate participants for any treatment-emergent adverse events, adverse events of special interest, and serious adverse events for up to 54 weeks. Safety assessments include monitoring physical examinations, vital signs, and ECGs. Participants must have completed earlier related studies without safety concerns to join, and their health will be closely monitored during the study to ensure safety and tolerability.

Researchers are evaluating the impact of the Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution on blood sugar control in adults with Type 1 or insulin-dependent Type 2 diabetes who use multiple daily insulin injections. The study aims to compare the change in the percentage of time blood glucose levels stay within the target range of 70 to 180 mg/dL between those using the CGM device and those using traditional self-monitoring of blood glucose (SMBG). This open-label, randomized, multi-center trial focuses on how the CGM may affect overall glucose management. Participants are randomly assigned to one of two groups: one group uses the Accu-Chek SmartGuide CGM device along with two smartphone apps that display and analyze real-time glucose data, while the other group wears the CGM sensor with blinded apps and relies on their own SMBG devices or a provided Accu-Chek Instant meter for calibration. The CGM sensor is worn intermittently during assessment periods in the control group. Both groups participate over specified baseline and assessment periods to track changes. During the study, participants will be monitored for changes in the time their blood glucose stays within the target range, comparing baseline weeks to assessment weeks. Researchers will gather glucose readings from the devices and apps, and participants will be assessed through lab tests such as HbA1c, with ongoing safety monitoring. The total duration includes baseline and subsequent assessment periods, allowing detailed comparison of glucose control using CGM technology versus traditional blood glucose monitoring.

Researchers are evaluating the effects of intravenous ferric carboxymaltose (FCM) compared to placebo in patients who recently experienced an acute myocardial infarction (AMI) and have iron deficiency. This phase 4, multicenter, randomized, double-blind, placebo-controlled trial aims to assess whether FCM impacts mortality, heart failure events, serum NT-proBNP levels, and quality of life over a follow-up period of up to 36 months. The study specifically looks at the number and timing of heart failure events, changes in heart failure biomarkers, and quality of life using the EQ-5D questionnaire.