Phase 2 Motor Neurone Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Adults aged 18 or older who have been diagnosed with ALS (either inherited or not inherited from a family member).
- In Part 1 of the study: people whose ALS is expected to progress at a certain rate, measured by a specific scoring system called the ENCALS risk profile (score between -6 and -3) (confirm with trial site).
- In Part 2 of the study: people whose ALS is expected to progress at a certain rate, measured by a different scoring system called the TRICALS risk profile (score between -7 and -3) (confirm with trial site).
- People already taking riluzole, edaravone, and/or sodium phenylbutyrate with taurursodiol, as long as the dose has been stable for a set period before the study begins (note: sodium phenylbutyrate with taurursodiol is not allowed in Part 2).
- In Part 2 only: people with a specific genetic mutation (in the SOD1 gene) who are not currently receiving or eligible to receive a drug called tofersen, or who previously tried tofersen but stopped due to safety or effectiveness concerns.
- In Part 2 only: people taking a very high dose of a vitamin B12 treatment (methylcobalamin) for ALS, as long as the dose has been stable for at least 11 weeks before the study starts.
Who may not be able to join:
- People who have a significant neurological condition other than ALS.
- People who are unable to swallow capsules.
- People with a low blood platelet count (below 150,000/mm³), which can affect how the blood clots.
- People with poor kidney function, based on a specific kidney test result (eGFR of 30 or below); in Part 2, people who recently had a sudden decline in kidney function must have recovered to their normal kidney function before joining.
- People who have HIV, or an active or ongoing hepatitis B or hepatitis C infection (in Part 2, this also applies to people with a known history of these conditions).
- Women who are pregnant, planning to become pregnant, or currently breastfeeding.
- People who are already using breathing support devices, such as a non-invasive breathing machine, a ventilator connected through the throat, or any form of supplemental oxygen.
- People who are currently being treated for cancer (with some exceptions for certain early-stage or well-controlled skin or cervical cancers), or who have a cancer history where life expectancy is less than 2 years.
- People who currently need or are expected to need a diaphragm pacing system (a device that helps the breathing muscle work).
- People who have previously been treated with a type of drug called a glucocorticoid receptor modulator or antagonist (confirm with trial site).
- People who have recently used certain steroid medications (including tablets, inhalers, or strong skin creams/ointments) within a time period based on how long that specific steroid stays in the body; people who stop steroids should have another treatment option available if their condition gets worse during the study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Sophia Majeed, PharmD, PhD, Corcept Therapeutics Incorporated
Phone: (650) 249-9965
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
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; Incidence of treatment-emergent AEs and SAEs; Incidence of treatment-emergent AEs leading to dose interruptions, dose reductions, and/or discontinuations of study drug
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.