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:

• You have been diagnosed with ALS (Lou Gehrig's disease) using a specific set of recognised diagnostic guidelines called the Gold Coast criteria
• Your ALS symptoms started no more than 18 months ago
• You are between 18 and 75 years old
• Your ALS functioning score (a standard measure of daily abilities across 12 areas) is 30 or above (confirm with trial site)
• Your lung breathing capacity is at least 70% of what is considered normal
• You have been taking Riluzole (50 mg twice a day) for at least 30 days before the study starts, and you are expected to continue this dose throughout the study
• You are willing and able to follow all the requirements of the study
• You are willing to sign a consent form before any study procedures begin
• Women who could become pregnant must agree to use at least one reliable form of birth control (such as hormonal contraception, an IUD, surgical sterilisation, or complete abstinence) starting 30 days before treatment and throughout the study
• Men in the study must agree to use condoms combined with an effective contraceptive method used by their female partner, if their partner could become pregnant

Who may not be able to join:

• You have another brain or nervous system degenerative disease in addition to ALS
• You have significant memory or thinking problems, or dementia
• You have a psychiatric (mental health) condition that could affect your participation in the study
• You have taken high-dose vitamin B3 supplements in the 30 days before joining the study
• You have serious heart disease
• You have moderate to severe lung disease, such as emphysema or advanced COPD (stage III or IV)
• You have asthma that is not well controlled
• You currently have active cancer
• You have any other serious illness — physical or mental — that could put you at risk or affect the study results
• You have a confirmed genetic mitochondrial disease (a condition affecting how your cells produce energy)
• You already have a tracheostomy (a breathing tube in your throat) or a gastrostomy (a feeding tube in your stomach)
• You have taken part in another clinical trial using an experimental treatment within the past 30 days (or longer, depending on the previous treatment)
• You have any significant abnormal laboratory test results that could affect your safety or ability to take part
• You have an allergy to NAC or any ingredient in the study drug or the supplement being tested (confirm with trial site)
• In the opinion of the study doctor, you have a very short life expectancy
• Women who are pregnant or breastfeeding, or who could become pregnant and are less than 2 years past menopause or have not had surgical sterilisation
• You are not willing to use reliable contraception during the study

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