Sungai Petani

Researchers are evaluating the effects of evenamide as an additional treatment for patients with treatment-resistant schizophrenia who have not responded well to their current stable antipsychotic medications. This Phase III trial aims to compare the safety, tolerability, and effectiveness of adding evenamide at a dose of 15 mg twice daily versus a placebo over a 12-week period. The study plans to enroll about 400 participants, randomly assigning them equally into two groups. Participants will receive either evenamide capsules or matching placebo capsules twice daily as an add-on to their existing antipsychotic treatment for 12 weeks. The study is designed as a randomized, double-blind, placebo-controlled trial to ensure unbiased assessment of outcomes. After the treatment period, there is a 30-day safety follow-up to monitor adverse events. During the study, participants will undergo evaluations including the Positive and Negative Syndrome Scale PANSS to assess symptom changes, and monitoring for treatment-emergent adverse events. Additional assessments include severity of illness, global improvement ratings, social performance, and quality of life questionnaires conducted from baseline through week 12. Safety is closely monitored throughout the treatment and follow-up periods. The total participation lasts for approximately 12 weeks plus the 30-day safety follow-up.

Researchers are evaluating palazestrant OP-1250 compared to standard endocrine therapies for adults with ER-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy combined with a CDK46 inhibitor. This international phase 3 trial aims to assess the safety and effectiveness of palazestrant versus fulvestrant or aromatase inhibitors such as anastrozole, letrozole, or exemestane. Participants are randomly assigned to receive either palazestrant daily on a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or the standard-of-care endocrine therapy including fulvestrant administered on specific days or one of the aromatase inhibitors given daily on similar cycles. The trial includes an initial dose-selection period with about 120 participants, followed by a larger randomized phase with approximately 390 participants receiving the selected dose of palazestrant or standard treatment. Throughout the study, participants will be monitored for adverse events, dose adjustments, and drug discontinuations up to 16 weeks. Researchers will measure progression-free survival for up to two years and overall survival for up to four years after randomization. Regular assessments will include clinical evaluations and safety monitoring to observe the effects and tolerability of the treatments during the trial.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

Researchers are studying an experimental drug called REGN7508 and comparing it to Acetylsalicylic Acid ASA in adults undergoing elective, one-sided total knee replacement surgery. The study aims to evaluate how well REGN7508 prevents Venous Thromboembolism VTE and related conditions after surgery. This Phase 3 trial also investigates potential side effects, the amount of the study drug in the blood over time, and whether the body develops antibodies against the drug. Participants are randomly assigned to receive either REGN7508 with a placebo or ASA with a placebo. All treatments are given according to the study protocol. The trial is double-blinded and multicenter, ensuring neither participants nor researchers know who receives which treatment. The study period includes monitoring up to 90 days to assess safety and drug levels. During the trial, participants will be closely monitored for symptomatic VTE, death, bleeding events, and adverse effects through day 30 to day 90 visits. Blood samples will be collected to measure drug concentration and antibody development. Researchers will evaluate the time to events such as deep vein thrombosis, pulmonary embolism, and overall safety outcomes. The entire study is expected to last until July 2027.