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Corticosteroid

Dazucorilant for ALS (DAZALS Trial)

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights

DAZALS Trial Summary

This trial will test a new drug to see if it helps treat ALS and is safe to use.

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.Check my eligibility
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.See study design
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.

DAZALS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs.
Secondary outcome measures
Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Change from Baseline to Week 24 in Percent Slow Vital Capacity
Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer).

DAZALS 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.

Find a Location

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor
68 Previous Clinical Trials
6,152 Total Patients Enrolled
Grace Mann, PhDStudy DirectorCorcept Therapeutics
1 Previous Clinical Trials
39 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently enlisting participants?

"At the present time, this clinical trial is searching for suitable patients. It was originally posted on November 15th 2022 and has since been updated as recently as October 25th 2023."

Answered by AI

What is the total cohort of participants involved in this experiment?

"Affirmative. According to the records on clinicaltrials.gov, this research study is actively seeking participants and has been since November 15th 2022. Thus far, 27 different medical centres have recruited 198 patients for the trial which was last updated on October 25th 2023."

Answered by AI

How many locations have been established for this trial's implementation?

"Presently, 27 medical centres are enrolling patients for this trial. These sites span a range of locations from Valencia to Barcelona and many in between; thus, it is important to select the closest site so as to limit transportation requirements if you decide to join."

Answered by AI

Has the Federal Drug Administration certified CORT113176 (Dazucorilant) for a 300 mg dosage?

"CORT113176 (Dazucorilant) 300 mg is rated as a 2 on the safety scale, seeing that there are some supportive clinical data regarding its security but none indicating it's effectiveness."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
278

Why did patients apply to this trial?

My time is running out. I need help before ALS takes my life from me.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
2022. "Dazucorilant in Patients With Amyotrophic Lateral Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05407324.
All > Lou Gehrigs Disease > Als
~52 spots leftby Oct 2024
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