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 diagnosed with ALS according to the Gold Coast Criteria (a standard set of diagnostic guidelines used by neurologists)
• For the Phase 1b part of the trial: people whose first ALS symptoms began no more than 48 months (4 years) before the start of the study
• For the Phase 2 part of the trial: people whose first ALS symptoms began no more than 24 months (2 years) before the start of the study — first symptoms include weakness in the arms, legs, trunk, or problems with speech or swallowing
• People aged 18 to 80 years at the time of signing the consent form
• People who are able to eat and drink by mouth and do not rely on a feeding tube (such as a PEG or G-tube) at the time of screening
• People whose lung breathing capacity (measured by a test called slow vital capacity) is at least 60% of the expected level for their age and body size
• People taking riluzole (a common ALS medication) who have been on a stable dose for at least 60 days before the screening blood test
• People taking edaravone (another ALS medication) who have completed at least one full treatment cycle before screening
• People who are willing to follow the contraception requirements set out in the study protocol during the trial period
• People who are able to give their informed consent and follow the study requirements

Who may not be able to join:

• People who have a tracheostomy (a breathing tube in the throat) or who need mechanical ventilation (breathing machine support) for more than 22 hours a day for more than one week
• People who have a serious uncontrolled medical condition other than ALS — such as significant heart, lung, liver, kidney, digestive, hormonal, blood, or neurological conditions — that could affect how the study drug works in the body or affect safety, as determined by the investigator
• People with a history of cancer, except for certain types of treated skin cancer with no signs of spread (confirm with trial site for specific details)
• People who are pregnant, test positive for pregnancy at screening or on the first study day, or are breastfeeding on the first study day
• People with a spinal condition or deformity that may prevent a lumbar puncture (a procedure to collect fluid from around the spine)
• People with certain abnormal blood clotting test results, a very low platelet count, or who are currently taking blood-thinning medications such as warfarin, heparin, or direct oral anticoagulants
• People with a history of severe heart failure (classified as Class III or IV by standard medical guidelines)
• People who are unable to swallow or take oral (by mouth) medications at the time of screening
• People currently taking part in another clinical drug trial, or who have received an experimental drug within the past 30 days or 5 half-lives of that drug (whichever is longer) before screening
• People with a known allergy or sensitivity to the study drug NB-4746 or any of its ingredients
• People who have previously received the study drug NB-4746 at any time
• People currently taking or planning to take tofersen for ALS
• People for whom the investigator believes participation could compromise safety or affect the reliability of study results, for any reason
• People transitioning to the open-label extension (a further phase of the study) who do not do so within 30 days of completing the main study will need to be re-screened for some criteria (confirm with trial site)

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