The ADVANCE Clinical Study for AMN
The ADVANCE trial is a phase 2/3 randomized, double-blind, placebo-controlled, clinical study with an open-label extension that has been designed to assess the efficacy and safety of MIN-102 as a treatment for adrenomyeloneuropathy (AMN) in male patients with X-linked adrenoleukodystrophy.
The study is divided into two parts. The first part is a blinded placebo-controlled part with a 2:1 (active:placebo) randomization ratio and consists of two years of treatment where different efficacy and safety parameters are evaluated. This first part is followed-up by an open-label extension part where all participants completing part 1 will be eligible to receive MIN-102. This potentially pivotal study has been designed with input from both EMA and FDA as well as EU and US clinical experts in X-ALD and patient advocacy groups.
Over 100 patients are taking part in the ADVANCE study, which is anticipated to provide results by the end of 2020.
For further information visit: https://clinicaltrials.gov/ct2/show/NCT03231878?term=NCT03231878&rank=1