Molnlycke

Researchers are evaluating roxadustat, an oral medicine, to treat anemia in children and teenagers with chronic kidney disease (CKD). Anemia is a condition where the body has a low level of red blood cells. Currently, anemia is often treated with injections called erythropoietin stimulating agents (ESAs), but these have some safety concerns. Roxadustat is already licensed for adults with CKD, and this study aims to learn how it affects anemia in younger patients, providing a potential alternative to injections. Participants in this open-label Phase 3 study will take roxadustat three times a week for up to 52 weeks. The study starts with 10 teenagers taking a fixed dose for 4 weeks to determine the best dose, followed by 10 children doing the same. After dosing is established, the rest of the children and teenagers will take roxadustat at the suitable dose. Blood samples will be taken regularly, and doses may be adjusted to keep hemoglobin levels just below the normal range. Visits occur every 2 weeks for the first month, then every 4 weeks, with a final visit 4 weeks after treatment ends. During the study, participants will have their vital signs checked, including blood pressure, temperature, and heart rate. Those on dialysis will have fluid levels monitored. Blood and urine tests will be done regularly, including checks for hemoglobin, iron, liver enzymes, and heart function through ECGs. Medical exams occur before treatment and at 6 and 13 months. Researchers will monitor safety, treatment effects, and hemoglobin changes throughout the study.

Researchers are evaluating the safety and effectiveness of low-dose and high-dose atogepant in children and adolescents aged 6 to 17 who experience episodic migraine. Migraines are moderate to severe headaches often accompanied by symptoms such as throbbing pain, nausea, and sensitivity to light and sound. While several treatments exist for adults, options for younger patients are limited, making this Phase 3 study important to understand how atogepant works in this younger population. Participants aged 6 to 17 will be randomly assigned to one of six groups to receive either placebo, low-dose atogepant, or high-dose atogepant tablets taken once daily by mouth for 12 weeks. The exact doses for children aged 6 to 11 will be decided after a pharmacokinetic substudy. After 12 weeks, participants may either have a follow-up visit 4 weeks after stopping the treatment or join an extension study to continue taking atogepant for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and to monitor for any side effects. They will also complete questionnaires to evaluate how treatment affects their migraines. The main outcomes measured are changes in the number of monthly migraine days over 12 weeks and the number of participants experiencing adverse events during the first 16 weeks. About 450 participants will be enrolled across roughly 100 sites worldwide.

Researchers are studying relatively healthy 40-year-old adults to see if feedback and support after functional and medical examinations help inactive middle-aged people become more physically active. The study aims to find out if this intervention improves physical function, reduces pain, enhances quality of life, and lowers risk factors for lifestyle-related illnesses compared to standard medical feedback alone. This research is designed as a randomized controlled trial focused on lifestyle-related conditions. Participants undergo baseline and 1-year follow-up assessments that include standard medical and new functional examinations. Physical activity levels are measured objectively using accelerometers. The intervention group receives detailed feedback on their functional profile, including cardiovascular fitness, strength, mobility, balance, and posture, along with motivational interviewing and support to set realistic lifestyle goals. The control group receives feedback and advice only from the standard medical examination, including weight, blood pressure, and blood tests. During the study, participants will have their physical activity and sedentary behavior measured and monitored over one year. Researchers will assess changes in activity levels, function, motivation, health benefits, and quality of life. The study also tracks risk factors for lifestyle-related illnesses. The total participation involves initial and 1-year follow-up visits with medical and functional testing, feedback sessions, and goal-setting support for those in the intervention group.