Dazucorilant for ALS (DAZALS Trial)

Recruiting in Palo Alto (17 mi)

+35 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Corcept Therapeutics

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Exclusion Criteria

I have a serious nerve disorder that is not ALS.

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

I cannot swallow pills.

I have been treated with medications that affect cortisol receptors.

I use a breathing aid like a ventilator or oxygen.

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

Participant Groups

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.

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.