DAZALS

In this study, an investigational oral drug named dazucorilant (also called CORT113176) is being studied in people living with ALS (also known as MND) to understand its safety (side effects) and to determine if dazucorilant can slow down the worsening of the disease. The effects of dazucorilant will be compared to the effects of a placebo. This study is sponsored by Corcept Therapeutics.

Dazucorilant

Unbalanced levels of cortisol (a stress hormone) have been reported in people with ALS. Long exposure to higher levels of cortisol may increase inflammation in the nervous system. Dazucorilant is a small molecule that modulates cortisol activity which may reduce the neurotoxic effects of prolonged cortisol exposure. Therefore, it may slow functional loss and disease progression.

Study design

DAZALS is a phase 2 double-blind, randomized, placebo-controlled study. This means that the efficacy of dazucorilant is compared to a placebo. The placebo looks exactly like dazucorilant but contains no active drug. Participants will be randomly assigned to either the placebo or dazucorilant. You will have a two-thirds (2/3) chance of receiving dazucorilant. Neither you nor your study doctor or the study staff will know which treatment you are receiving.

During the study there will be 10 research visits over a period of 28 weeks. 7 visits will take place at the research centre and 3 visits will be by telephone. At the last visit in week 24, you can choose to continue with dazucorilant as part of an open-label study period. You will then continue visits both at the research centre and by telephone for up to 140 weeks. If you do not wish to participate in the open-label extension or are not eligible, you will be asked to continue study visits over the phone for up to 132 weeks.

The study drug (refers to both dazucorilant and placebo) is a softgel capsule packaged in a blister card. Study drug (4 capsules in total) should be taken by mouth once a day with food and 240 ml water, at approximately the same time each day.

Can I participate in the study?

The main criteria to participate in this study are:

• You are diagnosed with ALS.
• You are able to swallow capsules.
• If you are taking an approved treatment for ALS, you must be on a stable dose of that treatment prior to entering this study.

Registration and more information

If you are interested in this study and fit the above criteria, please contact one of the participating TRICALS centres below (contact details can be found by clicking on ‘read more’). They can provide you with more information and discuss any questions you may have. If you experience difficulty contacting a centre, you may reach out directly to the TRICALS operational team at info@tricals.org for support in this process.