Staudach Egerndach

Researchers are evaluating the optimal doses of E2086, an oral tablet, compared to a matching placebo in adults with narcolepsy to reduce excessive daytime sleepiness. This phase 2 randomized, double-blind, placebo-controlled trial focuses on measuring sleepiness using the Mean Sleep Latency (MSL) from four maintenance of wakefulness tests (MWTs). Participants include adults diagnosed with narcolepsy type 1 or type 2, with specific clinical and diagnostic criteria based on the 2023 International Classification of Sleep Disorders. Participants receive either E2086 or placebo tablets during the study. The treatment period lasts four weeks, during which participants complete the MWTs to assess changes in sleep latency. The study monitors the effect of the drug on daytime sleepiness compared to placebo and evaluates safety and tolerability. During the trial, participants will undergo assessments including sleep diaries, clinical history reviews, and MWTs at baseline and week 4. Researchers will measure changes in mean sleep latency to evaluate treatment effect. Safety monitoring includes tracking adverse events and clinical observations throughout the study. The total participation time includes screening, treatment, and follow-up assessments as required by the protocol.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and early effectiveness of the drug AZD9574 alone and combined with other anti-cancer treatments in adults with advanced solid cancers that have come back or progressed. This modular phase I/IIa study is open-label, multi-center, and involves dose escalation and expansion to assess treatments across various cancer types including breast, ovarian, pancreatic, prostate, glioma, and others, with about 695 participants planned. The study includes multiple modules: Module 1 tests AZD9574 monotherapy in cancers with specific gene mutations; Module 2 combines AZD9574 with temozolomide for glioma; Module 3 is a PET sub-study in Sweden; Module 4 combines AZD9574 with trastuzumab deruxtecan for HER2-positive and HER2-low breast cancers; and Module 5 combines AZD9574 with datopotamab deruxtecan for other solid tumors. Treatments are given orally or intravenously depending on the drug. Dose escalation and expansion phases are included, with up to 12 treatment cycles in some modules. Participants will have regular assessments including laboratory tests, ECGs, vital signs, imaging scans, tissue biopsies, and questionnaires to monitor safety, treatment effects, and disease status. Adverse events, dose-limiting toxicities, and performance status changes are tracked from first dose through approximately three years of follow-up. Female participants of childbearing potential and male participants have specific contraception requirements. Overall participation duration varies by module and treatment cycles.