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Found 3 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are assessing the long-term safety of eptinezumab in children and adolescents aged 6 to 17 who have chronic or episodic migraine. This Phase 3 extension study invites participants who completed prior migraine studies (19356A or 19357A) to continue treatment and monitoring. The study focuses on understanding how safe eptinezumab is when used over an extended period in this young population. Participants who completed the initial 12-week lead-in studies will join this open-label extension study. Those who previously received 100 mg or 300 mg doses of eptinezumab will continue with the same weight-adjusted dose. Participants who had placebo will be randomly assigned to receive either 100 mg or 300 mg of eptinezumab, also adjusted for weight. The medication is given as a concentrate for solution for infusion. During the study, researchers will monitor participants from baseline through week 44 to track any treatment-emergent adverse events. Safety assessments will guide ongoing participation, with particular attention to any serious reactions or liver-related test abnormalities encountered in the preceding studies. This extended observation aims to provide comprehensive safety data on eptinezumab use in young patients with migraine.
Actively Recruiting
Researchers are collecting detailed, real-world information over time about people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called METex14 skipping alteration. This study aims to understand how treatments for this type of lung cancer are used and how well they work and how safe they are in everyday clinical practice across multiple countries. It is a disease registry that observes patients without changing their treatment plans. Participants in this registry will continue to receive their usual cancer treatments as decided by their doctors, with no additional procedures or therapies imposed by the study. The registry gathers data on each participant's demographics, clinical features including biomarker information, treatment patterns, and outcomes related to effectiveness and safety. The study is non-interventional, meaning treatments are not assigned by the study but follow routine clinical care. Throughout the study, researchers will monitor and record best overall tumor response, tumor response using standard criteria (RECIST 1.1), overall survival, and the number of participants experiencing adverse events or reactions. This data collection will continue for up to approximately 4.9 years, enabling long-term follow-up of outcomes and safety in this patient population.