The Sponsor is a global pharmaceutical company focused on developing next-generation drugs to treat a number of CNS disorders. With headquarters in the US, the company has a diverse pipeline of products which it is committed to bringing to the US and global markets.
The Sponsor needed to end a long standing OLEX study, that was set up after its phase 3 trials had ended. However, the company wanted to continue providing drug access to patients, to fill the lag period before the product becomes commercially available.
This would involve closing out the OLEX study and transferring 861 patients, located across 19 different countries, into a new program.