Bodmin

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

Researchers are working to create two important resources focused on People with Intellectual Disabilities (PwID) who also have epilepsy. The first part aims to build a secure research database using de-identified medical information from participants at three NHS sites in England and Wales. This database will include clinical details, epilepsy history, and medications, all with personal identifiers removed. The goal is to see if it is possible to identify eligible participants, gather complete data, and find any issues that could affect data quality, which will guide a larger future study across more sites. The second part of the study focuses on developing a research register of individuals with PwID and epilepsy who are willing to participate in future research. Participants will be invited to consent to share their personal and clinical data securely. This register will help researchers identify and contact potential participants for other ethically approved studies, promoting collaboration and data sharing across projects to improve patient care. This part will also evaluate recruitment processes, screening rates, and how other researchers can access the register for approved studies. Participants will be involved through their medical record data, and those consenting to the register may be contacted for future research. The study will monitor the ability to collect complete datasets and track recruitment and screening rates at each site. The entire project is planned to continue until May 2025 and aims to enhance research capabilities for people with intellectual disabilities and epilepsy by creating valuable, accessible data resources.