Molnlycke

Researchers are evaluating roxadustat, an oral medicine, for treating anemia in children and teenagers with chronic kidney disease CKD. Anemia involves low red blood cell levels, and current treatments often use injections called erythropoietin stimulating agents ESAs with iron, but these have safety concerns. This Phase 3 open-label study aims to understand how roxadustat affects anemia in this young population, offering a potential alternative to ESA injections. Participants will take roxadustat orally or via gastric tube three times a week for up to 52 weeks. The study begins with a fixed dose for 4 weeks, during which blood hemoglobin levels are regularly checked to adjust dosing as needed to maintain target levels just below normal. The study starts with 10 teenagers and 10 children who receive fixed doses to determine appropriate dosing for others. After this, the remaining children and teenagers will take the optimized dose. Children and teenagers will visit the clinic frequently every 2 weeks during the first month and then every 4 weeks until the treatment ends, with a final visit 4 weeks after stopping roxadustat. At visits, vital signs, fluid status for dialysis patients, blood and urine tests, and medical exams will be conducted, including electrocardiograms at specific intervals. Researchers will monitor hemoglobin, iron levels, safety, growth, and quality of life over the study period, which may last up to 56 weeks including follow-up.

Researchers are evaluating the safety and effectiveness of atogepant, a medication approved for adults with migraine, in children and teens aged 6 to 17 who have a history of episodic migraine. This Phase 3 study addresses the limited approved treatments available for pediatric migraine sufferers and aims to better understand atogepants impact on this younger population. Participants will be randomly assigned to one of six groups based on age and dosage. Children aged 6 to 11 will participate in a pharmacokinetic substudy to determine the appropriate dose before receiving either placebo, low-dose, or high-dose atogepant tablets once daily for 12 weeks. Teens aged 12 to 17 will be randomized to receive placebo, low-dose, or high-dose atogepant tablets daily for 12 weeks. After this period, participants may have a follow-up visit 4 weeks after their last dose or join an extension study to continue atogepant treatment for an additional 52 weeks. During the study, participants will attend regular hospital or clinic visits for medical evaluations, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in the number of migraine and headache days, medication use, quality of life, and migraine-related disability. Safety will be monitored through adverse event reporting up to 16 weeks. The total study duration includes the 12-week treatment period with possible extension and follow-up assessments.

Researchers are evaluating how functional examinations and personalized feedback impact physical activity and health in relatively healthy 40-year-olds who are physically inactive. The study aims to find out if motivational interviewing and detailed functional profiles encourage participants to increase their activity levels and improve health measures such as pain, function, quality of life, and risk factors for lifestyle-related illnesses. Participants are randomly assigned to one of two groups. One group receives medical and functional health examinations, physical activity measurement via accelerometers, a detailed functional profile, personalized feedback, and support with goal setting for lifestyle changes. The control group undergoes similar examinations and measurements but only receives feedback based on the medical exam without the functional profile or additional motivational support. During the study, participants will have health and function assessments at the start and after one year, including questionnaires and measurements of fitness, strength, balance, mobility, posture, pain, and quality of life. Researchers will monitor changes in physical activity and sedentary behavior, motivation, and various health indicators. The total participation time spans one year with comparisons made between baseline and follow-up results.