A Phase I Study inNiemann Pick: CTD Holdings

The Challenge

Aptus Clinical was asked by CTD Holdings to join their International Project Team to support the development of TRAPPSOL® CYCLO® for the treatment of Niemann
Pick type C

The Solution

The Aptus Clinical team of experts work flexibly to support the project needs. Initially this focused on providing strategic input into the development plan for TRAPPSOL® CYCLO® and putting in place quality management infrastructure to support the compliant conduct of the study. Global Project Management and Clinical Operations support for site set-up, recruitment and monitoring is the current focus

The Outcome

The Aptus Clinical team is in place and has secured UK ethics approval and NIHR adoption. Two UK sites have been set up, with a third paediatric site underway. Recruitment commenced  in June 2017. The team also identified other CRO partners to support the sites in Sweden, Italy and Israel. Recruitment is planned to close in the summer of 2018, with the last patient completing the study 12 months later

The Feedback

The client is delighted with the study progress to date and is anticipating early completion of the recruitment phase