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Axsome Therapeutics accelerates the completion of its ADVANCE-1 trial of AXS-05 in AD agitation

Friday 20 March 2020

On 20 March, the company Axsome Therapeutics, which develops therapies for the management of central nervous system disorders, announced that it is accelerating the completion of its ADVANCE-1 trial of AXS-05.

The Phase II/III ADVANCE-1 study is a multicenter, randomised, double-blind and controlled trial to evaluate the efficacy and safety of AXS-05 in people with agitation associated with Alzheimer’s disease (AD). In the original protocol of the trial, approximately 435 research participants over 65 years old were to be enrolled to receive the drug or the placebo for 5 weeks.

To ensure the safety of research participants during the COVID-19 outbreak, the company is concluding participant’s enrolment early. The decision was made in compliance with the new guidance from the US Food and Drug Administration, which reports the potential impact of the COVID-19 pandemic on the conduct of clinical trials and the safety of research participants.

More than 90% of research participants are estimated to have completed the study. Topline results should be available in the second quarter of 2020.