At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Dazucorilant 300 mg (drug), Dazucorilant 150 mg (drug), Placebo (other), Dazucorilant (drug)
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- Dazucorilant 300 mg — drug: 300 mg of dazucorilant will be administered once daily in 4 capsules of 75 mg dazucorilant/capsule. · Dazucorilant 150 mg — drug: Dazucorilant and placebo will be administered once daily in 4 capsules, 2 capsules with 75 mg dazucorilant/capsule, and 2 capsules of placebo equivalent. · Placebo — other: Placebo will be administered once daily in capsules of placebo equivalent. · Dazucorilant — drug: Dazucorilant will be administered once daily in 75-mg capsules.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 279
- Started
- 2022-11-15
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for amyotrophic lateral sclerosis
- • Phase2 - 279 participants
- • The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with amyotrophic lateral sclerosis
Where?
- • Stoke-on-Trent - 263
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).
More detail
In Part 1, eligible ALS patients will be randomized to one of three treatment arms (1:1:1) across North America and Europe for a 24-week double-blind treatment period. Patients who complete participation (i.e., complete all visits) in the double-blind treatment period will be eligible for participation in a 132-week open-label extension (OLE) study. A daily dose of 300 mg dazucorilant will be used in the OLE period. Patients who complete the double-blind treatment period and who do not enter the OLE will enter the 132-week follow-up period. In Part 2, eligible ALS patients will receive open-label treatment to evaluate dose titration and tolerability of dazucorilant. The dose titration will begin with an initial 75 mg once daily dose, and the dose will be titrated up as tolerated in 75 mg increments until the 300 mg once daily target dose is reached and maintained for 3 weeks. Patients who complete participation in the dose-titration treatment period will be eligible to continue treatment with dazucorilant 300 mg once daily in a 52-week open-label extension portion of the study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ tofersen
What the study is looking for
- ✓Part 2 only: Use of ultra high-dose methylcobalamin for the treatment of ALS is permitted provided the patient has...
Who cannot take part
- ✗History of a clinically significant non-ALS neurologic disorder
- ✗Inability to swallow capsules.
- ✗Blood blood clotting cell count \<150,000/mm\^3.
- ✗Women who are pregnant, planning to become pregnant, or are breastfeeding.
- ✗Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, or on any form of oxygen...
See the full criteria
Where Is This Study? (1 UK site)
263
Stoke-on-Trent ST4 6QG, United Kingdom
