Aladote: approval from data safety monitoring committee

Sep 14, 2017

The Aladote study in patients treated for paracetamol overdose is now open for recruitment for the next dosage group.

The data safety monitoring committee gave the approval to initiate the next cohort in the open-label, randomised, rising dose design, proof-of-principle  safety and tolerability study with Aladote in patients treated with NAC for paracetamol overdose.

The study is conducted at the University of Edinburgh, Queen’s Medical Research Institute in Scotland and will involve a total of 24 patients assigned into one of 3 dosing cohorts of 8 patients.

The first cohort receiving the lowest dose of the study drug has been completed and after reviewing the safety data the monitoring committee, in a meeting held on September 13, approved to continue with recruitment for the middle dose group.