Phase 2 Motor Neurone Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 80 years old, of any gender
• People whose ALS symptoms first began no less than 6 months ago and no more than 2 years ago
• People who have received a formal ALS diagnosis that meets a specific international diagnostic standard (the El Escorial revised criteria, 2000), at any of the recognised diagnostic levels
• People who score at least 2 on every section of a standard ALS functioning scale (ALSFRS-R), and specifically score 4 on the sections related to breathing difficulty, nighttime breathing, and respiratory problems
• People whose body mass index (BMI) falls between 18 and 30
• People whose lung breathing capacity (measured as %FVC) is 70% or above at the start of the trial
• People who have been taking riluzole or edaravone at standard doses for at least 30 days, or who are on regular intravenous edaravone with a plan to switch to the oral form — and who are able to keep their medication type and dose unchanged throughout the trial
• People who are able to use reliable contraception starting 2 weeks before joining the trial and continuing until the end of the follow-up period (applies to people who could become pregnant)
• People who are able to sign a consent form themselves or through a legal representative, and who are able to follow the trial's requirements for taking medication and attending follow-up appointments

Who may not be able to join:

• People whose condition has been assessed and found not to be ALS based on clinical tests such as nerve studies, MRI, or blood tests
• People who have abnormal nasal anatomy, nasal injury, severe nasal inflammation, or any nasal condition that could affect how the study drug is delivered through the nose
• People who require a feeding tube inserted through the nose
• People whose blood test results fall outside acceptable ranges, including low red blood cell levels, low white blood cell counts, low platelet counts, low protein levels, or significantly elevated liver enzyme levels (confirm specific values with trial site)
• People with severely reduced kidney function, or other known serious kidney disease
• People who test positive for certain infectious diseases, including active hepatitis B (with detectable virus in the blood), hepatitis C, syphilis, or HIV
• People who have had a heart attack or heart procedure in the past 6 months, or who have advanced heart failure
• People who currently have a serious local or widespread infection, a weakened immune system, or who are taking medication that suppresses the immune system
• People who have other serious systemic illnesses, including immune disorders, blood clotting disorders, or cancer
• People who have received a vaccine within 1 month before the trial starts, or who would need to be vaccinated during the trial or follow-up period
• People with a known allergy to the study drug or similar drugs
• People who have taken part in another clinical trial and received an experimental treatment within the past 3 months
• People who are unable to have an MRI scan, for example due to metal implants in their body, or who are unable to tolerate MRI, for example due to severe claustrophobia
• People who are pregnant or breastfeeding, or people who could become pregnant and are unwilling or unable to use appropriate contraception
• People who are unwilling or unable to follow the procedures required by the trial
• People considered unsuitable for any other reason, as determined by the trial investigators

Important: Always verify eligibility with the trial site directly before applying.