XePOHCAS - Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 02 Oct 2017
At a glance
- Drugs Xenon (Primary)
- Indications Chronic brain damage
- Focus Registrational; Therapeutic Use
- Acronyms XePOHCAS
- Sponsors NeuroproteXeon
- 02 Oct 2017 According to a Mallinckrodt plc media release, assuming full completion of the trial, the company expects the regulatory submission to be a drug and delivery device combination and anticipates receiving U.S. regulatory approval in late 2020.
- 02 Oct 2017 According to a Mallinckrodt plc media release, the Special Protocol Assessment that has been approved by the FDA allows for an interim analysis at 50% of trial completion of the primary endpoint follow up, and if the primary and secondary endpoints are positive at that review the trial would be halted for success. If the primary or secondary endpoints are futile at that point, the trial will be stopped for futility.
- 02 Oct 2017 According to a Mallinckrodt plc media release, the FDA has granted a Special Protocol Assessment for this trial and the company expects to initiate this trial in 2018.