What side effects are associated with this type of intervention?

The most common treatments for ALS include riluzole and edaravone. Riluzole can cause side effects such as nausea, weakness, decreased lung function, and liver damage. Edaravone is associated with side effects like bruising, gait disturbance, headache, and allergic reactions. For treatments similar to CORT113176 (dazucorilant), which is a Selective Glucocorticoid Receptor Modulator, potential side effects may include those commonly seen with glucocorticoid treatments, such as increased risk of infections, impaired glucose tolerance, and weight gain. However, specific side effects for dazucorilant are still being studied.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Amyotrophic Lateral Sclerosis (ALS), including riluzole and edaravone. Riluzole is believed to reduce damage to motor neurons by decreasing the release of glutamate, while edaravone is thought to act as an antioxidant, reducing oxidative stress. There are no FDA-approved treatments specifically classified as Selective Glucocorticoid Receptor Modulators (SGRMs) for ALS. The ongoing study of CORT113176 (dazucorilant) represents an exploration into new therapeutic mechanisms for managing ALS symptoms.

What other types of research exist?

Promising novel alternatives to CORT113176 (dazucorilant) for ALS patients include dexpramipexole, which has been studied in phase III trials, and cannabinoids, which have shown potential in treating related symptoms and co-morbidities. Additionally, N-acetylcysteine has been explored in pilot trials for its neuroprotective properties. Emerging genetic therapies and neuroprotective agents are also being actively researched.

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Corticosteroid

Dazucorilant for ALS (DAZALS Trial)

Phase 2

Waitlist Available

Research Sponsored by Corcept Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of a clinically significant non-ALS neurologic disorder

Currently using glucocorticoids or have a history of regular systemic glucocorticoid use within the last 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medication called dazucorilant to see if it can help people with ALS. ALS is a serious disease with few treatment options, so new treatments are needed. The medication might work by slowing down the disease or making symptoms less severe.

Who is the study for?

This trial is for men and women over 18 with ALS, either sporadic or familial. Participants must be on a stable dose of riluzole/edaravone if taking them. Excluded are those with significant non-ALS neurological disorders, prior glucocorticoid modulator treatments, swallowing issues, recent systemic glucocorticoid use, need for diaphragm pacing systems or ventilation support, pregnant/breastfeeding women, and individuals with HIV or hepatitis B/C.

What is being tested?

The study tests the safety and effectiveness of dazucorilant in ALS patients. It involves two different doses of dazucorilant (300 mg and 150 mg) compared to a placebo to see which works better at managing symptoms.

What are the potential side effects?

Potential side effects may include reactions similar to those seen with other drugs affecting the body's hormone balance such as changes in blood sugar levels, mood alterations, increased risk of infections due to immune system suppression, muscle weakness or bone density loss.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious nerve disorder that is not ALS.

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I am currently using or have used glucocorticoids regularly in the past year.

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I cannot swallow pills.

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I have been treated with medications that affect cortisol receptors.

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I use a breathing aid like a ventilator or oxygen.

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I do not have HIV or active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: CORT113176 (Dazucorilant) 300 mgExperimental Treatment1 Intervention

300 mg of dazucorilant will be administered once daily.

Group II: CORT113176 (Dazucorilant) 150 mgExperimental Treatment1 Intervention

150 mg of dazucorilant will be administered once daily.

Group III: Placebo (matched to study drug)Placebo Group1 Intervention

Placebo will be administered once daily.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Amyotrophic Lateral Sclerosis (ALS) include Riluzole, Edaravone, and investigational drugs like Dazucorilant. Riluzole works by inhibiting glutamate release, which is thought to reduce excitotoxicity that leads to motor neuron death. Edaravone acts as a free radical scavenger, reducing oxidative stress, which is implicated in the progression of ALS. Dazucorilant, a selective glucocorticoid receptor modulator, aims to modulate the body's stress response and inflammation, potentially offering neuroprotection. These mechanisms are crucial as they target different pathways involved in ALS progression, offering hope for slowing disease progression and improving quality of life for patients.

Combinatory Biomarker Use of Cortical Thickness, MUNIX, and ALSFRS-R at Baseline and in Longitudinal Courses of Individual Patients With Amyotrophic Lateral Sclerosis.[Clenbuterol in amyotrophic lateral sclerosis. No indication for a positive effect].