Penticton

This trial investigates whether eptinezumab can reduce the number of migraine days in children and teenagers aged 6 to 17 with episodic migraine. The study focuses on pediatric participants who have had migraine headaches for at least six months, aiming to evaluate the preventive treatment potential of this medication. This is a Phase 3 randomized, double-blind, placebo-controlled study designed to assess both the effectiveness and safety of eptinezumab given intravenously. Participants will receive either eptinezumab or a placebo, both administered as a solution through an infusion. The study includes a screening period where migraine and headache frequency are recorded using an electronic diary. The main measurement is the change from baseline in the average number of monthly migraine days over the first 12 weeks of treatment. During the study, participants and their caregivers will complete headache diaries to track migraine occurrences. Researchers will monitor migraine frequency and evaluate safety throughout the trial. The primary outcome is the difference in migraine days per month compared to the start of the study, assessed over the 12-week treatment period. This study helps understand how well eptinezumab may prevent episodic migraine in the pediatric population.

Researchers are evaluating whether eptinezumab can reduce the number of migraine days in young people aged 12 to 17 who have chronic migraine. The study is a Phase 3, randomized, double-blind, placebo-controlled trial designed to compare eptinezumab with a placebo in preventing chronic migraine in adolescents. Participants must have a history of chronic migraine for at least six months as defined by recognized headache disorder guidelines. Participants will receive a single intravenous infusion of either eptinezumab at doses of 100 mg or 300 mg, adjusted by body weight to match adult exposure, or a placebo solution. The study includes a 4-week screening period, followed by a 12-week double-blind treatment period, and then an 8-week safety follow-up. Participants are randomly assigned in a 1:1:1 ratio to one of the three groups. Throughout the study, participants will complete headache diaries to record migraine frequency and characteristics. Researchers will measure the change from baseline in monthly migraine days averaged over the first 12 weeks of treatment to assess efficacy. Safety monitoring continues through the follow-up period, with the total participation lasting approximately 24 weeks from screening through follow-up.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.