Phase 3 Motor Neurone Disease Trial, Recruiting

Written by an AI model from the 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 have been diagnosed with Motor Neurone Disease (MND), including ALS (possible, probable, or definite), Primary Lateral Sclerosis, or Progressive Muscular Atrophy
• People who are over 18 years old
• Women who could become pregnant must have a negative pregnancy test within 7 days before, or at, their first trial visit
• Women who could become pregnant and men who are fertile must use an appropriate form of contraception from the time they agree to join until 4 weeks after finishing treatment
• People who are willing and able to follow the trial procedures and complete questionnaires
• People who can give written consent to join (if hand or arm movement is difficult, verbal consent given in front of a witness who can sign is accepted)

Who may not be able to join:

General criteria:

• People who have been diagnosed with Frontotemporal Dementia combined with MND (FTD-MND), or any other significant psychiatric condition that prevents them from giving informed consent
• People with current significant alcohol use (assessed by the trial doctor)
• People who are currently experiencing active thoughts of suicide, as assessed by a standard rating scale
• People currently taking part in another clinical trial or using another experimental treatment or device
• Women who are pregnant or breastfeeding
• People whose liver function blood tests (ALT, ALP, bilirubin, or GGT) are more than 3 times the normal upper limit
• People whose kidney function (measured by creatinine clearance or eGFR) is below 35 ml/min
• People with thyroid hormone levels outside a specific range (TSH below 0.2 mU/L, or free T4 above 25 pmol/L if tested)
• People whose heart rhythm measurement (QT interval on an ECG) is above 500 ms
• People diagnosed with certain heart rhythm problems, significant heart block (at the trial doctor's discretion), or who have had a heart attack within the last 6 weeks
• People who the lead investigator believes will not be able to follow the trial procedures

For the Amantadine treatment arm specifically:

• People currently in the manic phase of bipolar disorder
• People with a confirmed history of peptic ulcer (confirmed by endoscopy)
• People with active epilepsy
• People already taking amantadine
• People with a known allergy or sensitivity to amantadine or its ingredients, including hereditary fructose intolerance, or any medical history that makes amantadine unsuitable

For the Tacrolimus treatment arm specifically:

• People with poorly controlled high blood pressure (above 180/100 mmHg)
• People with poorly controlled diabetes (HbA1c above 6.4% or 48 mmol/mol)
• People with certain heart conditions, including hypertrophic cardiomyopathy, a personal or family history of prolonged QT interval, heart failure, slow heart rhythms, or abnormal electrolyte levels
• People with bleeding disorders, significant blood or immune system conditions — including immune deficiency, low red blood cell count (anaemia), or low platelet count — or people currently using other immune-suppressing treatments including steroids
• People with an active or long-term infection (at the trial doctor's discretion)
• People with a history of Hepatitis B or C
• People with a history of lymphoma or a currently active cancer
• People at risk of dehydration due to difficulty eating or drinking and no access to fluids given through a drip
• People for whom tacrolimus is medically contraindicated according to the medication's official prescribing information
• People taking certain other medications that are known to interact with tacrolimus, including (but not limited to) some antifungals, HIV medications, rifampicin, phenytoin, carbamazepine, barbiturates, certain antibiotics, digoxin, statins, some stomach acid medications, ergotamine, some antidepressants, and herbal supplements such as St. John's Wort (confirm full list with trial site)
• People who are unable to swallow capsules
• People already taking tacrolimus
• People with a known allergy or sensitivity to tacrolimus or its ingredients, including lactose or gelatin intolerance, or any medical history that makes tacrolimus unsuitable
• People who have received a live vaccine within the four weeks before starting tacrolimus — this includes vaccines such as live flu spray (Fluenz Tetra), shingles (Zostavax), chickenpox (Varilrix/Varilvax), oral typhoid, and yellow fever vaccines

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