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 are 18 years old or older at the time of signing the consent form.
• You have been officially diagnosed with ALS (Lou Gehrig's disease).
• Your ALS muscle weakness began no more than 24 months (2 years) before your screening visit.
• You have had genetic testing confirming you do not carry the SOD1 or FUS gene mutations (people with other ALS-related gene mutations may still be considered — confirm with trial site).
• Your lung breathing capacity (measured sitting down) is at least 50% of what would be expected for someone of your sex, age, and height.
• You are healthy enough to attend all study visits and complete all study procedures, in your doctor's opinion.
• You are willing and able to use effective birth control during the study and for 5 months after your last dose of the study treatment.
• If you are taking riluzole, you have been on a stable dose for at least 30 days before the study starts and plan to stay on that dose throughout.
• If you are taking edaravone, you have been taking it for at least 60 days (2 treatment cycles) before the study starts and plan to continue throughout.
• You are able to understand the study's purpose and risks and are willing to sign a consent form.

Who may not be able to join:

• You have taken another experimental drug, biological treatment, or used an experimental device within the past month (or within 5 half-lives of that treatment, whichever is longer), or have ever received small interfering RNA therapy, stem cell therapy, or gene therapy.
• You are currently enrolled in another interventional clinical trial.
• You have had issues with drug or alcohol misuse within the past 6 months that could affect your participation, in your doctor's opinion.
• You currently have an active infection that is not being properly treated.
• You have an ongoing medical condition (such as severe weight loss or severe anaemia) that could interfere with the study, in your doctor's opinion.
• You have another nerve or muscle condition that is expected to worsen during the study or affect certain test results, in your doctor's opinion.
• You are currently pregnant or breastfeeding.
• You have significant memory or thinking problems, dementia, psychosis, thoughts of suicide, a recent suicide attempt, or untreated severe depression within the past 90 days.
• You have a history of allergies to a wide range of anaesthetics.
• You have had a tracheostomy (a surgical opening in the throat for breathing).
• You have a condition or physical factor that puts you at increased risk of uncontrolled bleeding, including bleeding disorders (such as haemophilia or Von Willebrand's disease), liver disease, or physical abnormalities near the lower spine area (confirm with trial site).
• You need to take blood-thinning or anti-clotting medications that cannot be safely paused around the time of a spinal fluid (lumbar puncture) procedure.
• You have an implanted device that drains fluid from around your brain or spinal cord, or an implanted catheter in your central nervous system.
• Your blood test results show abnormalities that your doctor feels would make participation unsafe.
• You are unable or unwilling to follow the study's requirements.
• There are other reasons your doctor feels would make participation unsuitable.

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