<p>The North Midlands MND Care and Research Network is based at University Hospitals North Midlands NHS Trust which has sites at Royal Stoke University Hospital and County Hospital, Stafford. It cares for patients with ALS throughout Staffordshire and parts of Cheshire.</p>



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Consultant Neurologist

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Thomas Lambert has been a Consultant Neurologist at University Hospitals North Midlands [&hellip;]

Thomas Lambert - TRICALS

Consultant Neurologist and Co-Director of North Midlands MND Care and Research Network Centre.

Jonathan Partridge has been a consultant neurologist at UHNM since 2008 and [&hellip;]

Jonathan Partridge - TRICALS

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<h2>Dazucorilant</h2>
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.
<h2>Study design</h2>
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.
<h2>Can I participate in the study?</h2>
The main criteria to participate in this study are:
<ul>
 	<li>You are diagnosed with ALS.</li>
 	<li>You are able to swallow capsules.</li>
 	<li>If you are taking an approved treatment for ALS, you must be on a stable dose of that treatment prior to entering this study.</li>
</ul>
<h2>Registration and more information</h2>
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.

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DAZALS trial

Industry trial

Current trials

Thomas Lambert

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North Midlands MND Care and Research Network Centre

Royal Stoke University Hospital

Royal Stoke University Hospital is a large teaching hospital and the main [&hellip;]

Royal Stoke University Hospital - TRICALS

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Thomas Lambert

Current trials

DAZALS trial