Erlinsbach

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 NT1. This study focuses on participants who have already been exposed to TAK-861 doses in previous clinical trials. The goal is to monitor how TAK-861 affects symptoms such as excessive daytime sleepiness and cataplexy episodes over a long period. All participants in this trial will receive TAK-861 tablets. Those who previously received a placebo will be randomly assigned to one of the TAK-861 dose groups. The study is a long-term extension conducted worldwide and is expected to last approximately five years or until the product is approved or the study is stopped. Participants may switch doses as needed and will attend multiple clinic visits, some of which can be done at home. Throughout the trial, participants will be regularly assessed for safety by tracking any treatment-emergent adverse events. Researchers will also measure changes in sleep latency, sleepiness scores, and cataplexy rates compared to baseline data from earlier trials. Follow-up assessments will take place four weeks after the final dose to monitor ongoing effects and ensure participant safety.

Researchers are studying TAK-861 to evaluate its effectiveness and safety for treating narcolepsy type 1 with cataplexy. This phase 3 trial aims to determine whether TAK-861 helps control symptoms and if its benefits last over time, as well as to monitor any side effects related to taking or stopping the drug. Participants will first take TAK-861 openly for several months during the open-label treatment period. Those who meet certain criteria will then be randomly assigned to continue TAK-861 at the same dose or switch to placebo for up to 4 weeks in a double-blind randomized withdrawal period. If symptoms worsen during this period, participants may stop treatment and join a long-term extension study or be followed for 4 weeks after their last dose. During the study, participants will undergo assessments including the Epworth Sleepiness Scale, Maintenance of Wakefulness Test, cataplexy rate tracking, cognitive tests, and patient-reported outcomes. Safety will be monitored throughout the trial, which lasts approximately 31 weeks from screening to study end. The study is conducted at multiple centers worldwide.

Researchers are evaluating the effects of a digital lifestyle intervention on health-related quality of life HRQoL in survivors of non-small cell lung cancer NSCLC. Lung cancer survivors often experience ongoing symptoms like fatigue and breathing difficulties after treatment, which can lower their physical and psychological functioning. This study aims to support survivors beyond treatment by promoting physical activity, healthy eating, and breathing and relaxation exercises. Participants will be randomly assigned to either use a self-management mobile application focused on physical activity, nutrition, and breathingrelaxation for three months or receive usual care without changes to their planned treatments. The mobile app includes personalization and interactive features and one virtual appointment to help users get familiar with it and set appropriate goals. The intervention is based on behavior change techniques such as goal setting, feedback, and monitoring. Throughout the study, participants will be assessed on changes in overall and lung cancer-specific quality of life, physical activity, exercise capacity, psychological distress, fatigue, nutrition risks, and self-rated health over three months. Researchers will monitor these outcomes regularly to understand the interventions impact. The study period lasts three months, during which participants will complete questionnaires and other evaluations related to their health and well-being.