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 who are able to understand the study information and are willing to sign a consent form.
• Adults aged 18 to 85 years old at the time of signing the consent form.
• People who have a confirmed diagnosis of familial or sporadic ALS, meeting specific diagnostic standards set by the World Federation of Neurology.
• People whose ALS symptoms began less than 36 months (3 years) ago.
• People whose lung function (breathing capacity) is at least 50% of the expected normal level.
• People who are able to swallow tablets whole, without crushing them.
• Women who are not pregnant, not breastfeeding, do not plan to become pregnant during the study, and agree to use an appropriate form of contraception for the duration of the study.
• Men who, if their partner could become pregnant, agree to use a reliable form of contraception during the study and agree not to donate sperm during this period.
• People who are already taking standard ALS medications (such as Riluzole, Edaravone, or Albrioza) must have been on a stable dose of that medication for at least 30 days before joining the trial, and must agree to keep that dose the same throughout the study.
• For those who choose to take part in an optional tissue biopsy: people with normal blood platelet and clotting test results, or people on blood-thinning medications who are willing to pause those medications for a period before and after the biopsy, as directed by the study doctor.

Who may not be able to join:

• People who have untreated or uncontrolled narrow-angle glaucoma, stomach emptying problems (gastric retention), difficulty passing urine (urinary retention), or liver disease.
• People with a known history of severe allergic reactions, including anaphylaxis, to a type of medication called antimuscarinics.
• People who have also been diagnosed with another neurological condition such as Multiple Sclerosis, Parkinson's disease, Myasthenia Gravis, or Alzheimer's disease.
• People with severe liver impairment, classified as Child-Pugh B or C, or who have abnormal liver enzyme levels.
• People who have a history of, or test positive for, the hepatitis C virus at the screening visit.
• People with active or ongoing hepatitis B or hepatitis C infection.
• People with any other medical condition that, in the trial doctor's judgement, could interfere with participation, increase risk, or affect how results are assessed.
• People with any other uncontrolled medical condition besides ALS, as determined by the trial doctor.
• People who are currently enrolled in another clinical trial and receiving an investigational (experimental) treatment, including stem cell or gene therapy.
• People who have taken an experimental drug within 1 month, or within 5 half-lives of that drug (whichever is longer), before starting this study.
• People who have previously been treated with darifenacin (the study drug).
• People with a history of drug or alcohol misuse, as determined by the trial doctor using standard diagnostic guidelines.
• Women who are pregnant, breastfeeding, or planning to conceive during the course of the study.
• People with an abnormal heart tracing (ECG) at the screening visit that the trial doctor believes could put them at risk by joining the study.
• People currently taking certain medications that strongly affect how the body processes drugs, including some anticonvulsants (carbamazepine, phenytoin), certain antibiotics (rifampin), or wakefulness-promoting agents (modafinil).
• People currently taking certain medications that strongly block a specific liver enzyme, including some antibiotics (clarithromycin), antifungal medications (ketoconazole, itraconazole), certain antidepressants (nefazodone), or certain HIV medications (nelfinavir, ritonavir).
• People who are taking, or have taken within 30 days before the trial, certain heart or psychiatric medications that interact with a specific liver enzyme, including flecainide, thioridazine, or tricyclic antidepressants.
• People who have received botulinum toxin (Botox-type) injections in the past 6 months.
• People who are taking, or have taken within 30 days before the trial, certain bladder medications called antimuscarinics, such as fesoterodine, oxybutynin, solifenacin, tolterodine, or trospium.
• For those who choose to take part in the optional muscle biopsy only: people taking blood-thinning medications (with the possible exception of aspirin, at the doctor's discretion), or people who are at risk of increased or uncontrolled bleeding from a muscle biopsy.
• For those who choose to take part in the optional muscle biopsy only: people with bleeding risk factors, such as abnormal blood vessels or other abnormalities near the biopsy site, or abnormal platelet or clotting test results.

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