Early Phase 1 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:

• Adults aged 18 or older.
• People who have been diagnosed with ALS (also called Lou Gehrig's disease) that meets a specific set of recognised diagnostic standards called the "El Escorial criteria" — covering possible, probable, or definite ALS diagnoses.
• People whose lungs are working at more than 60% of expected capacity, as measured by a standard breathing test called forced vital capacity (FVC).
• People who are able to swallow tablets by mouth. A feeding tube is allowed, but the trial medication must be taken by swallowing — not through the tube.
• People who are experiencing significant symptoms of depression, as shown by a score above 22 on a specific depression questionnaire called the ADI-12.

Who may not be able to join:

• People with severe difficulties speaking, including those who cannot speak, rely on speech-assist devices, or can only communicate by writing or texting.
• People who are not able to give their own informed consent to participate.
• People who use a tracheostomy (a breathing tube in the throat), or who rely on continuous CPAP or BiPAP breathing support machines.
• People with a known diagnosis of frontotemporal dementia (a type of brain condition affecting thinking and behaviour).
• People with certain heart or blood vessel conditions, including an abnormal heart rhythm reading on an ECG (such as atrial fibrillation), uncontrolled high blood pressure, a resting heart rate above 90 beats per minute, chest pain (angina), a mini-stroke (TIA) within the last 6 months, a previous stroke, or active circulation problems in the legs or lungs.
• People with epilepsy or a history of seizures.
• People with significant kidney disease, where kidney function falls below a certain level as measured by a standard calculation (confirm with trial site).
• People with insulin-dependent diabetes, or people taking tablets for diabetes who have a history of low blood sugar episodes.
• People who are pregnant, currently breastfeeding, or who are not using an effective method of contraception (such as hormonal methods, intrauterine devices, condoms, diaphragm, sterilisation, or abstinence).
• People who regularly take certain antidepressant medications that may interact with the trial drug, including some atypical antidepressants (such as mirtazapine, trazodone, vortioxetine, or vilazodone), tricyclic antidepressants (such as amitriptyline or nortriptyline), or monoamine oxidase inhibitors (MAOIs such as phenelzine or tranylcypromine).
• People who regularly take certain other medications that may interact with the trial drug, including Nuedexta, efavirenz, disulfiram (Antabuse), or certain other specific drugs (confirm with trial site for the full list).
• People who have been diagnosed with, or have a history of, schizophrenia, a psychotic disorder, or Bipolar I Disorder (as defined by standard psychiatric diagnostic guidelines), unless the condition was caused by a substance or a medical condition.
• People who have a parent, sibling, or child diagnosed with schizophrenia, a psychotic disorder, or Bipolar I Disorder (unless caused by a substance or medical condition).

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