Phase 3 Motor Neurone Disease Trial, Completed

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 given their consent to participate, either in writing or verbally
• People who have been diagnosed with ALS (also known as Motor Neurone Disease) that meets specific recognised diagnostic standards, supported by a nerve and muscle electrical test (EMG) reviewed by a specialist
• People who are able to swallow capsules and are expected to continue to do so throughout the study
• People whose lung breathing capacity (measured while sitting) falls between 60% and 90% of what would be expected for someone of their age, height, and sex
• People whose ALS symptoms (such as muscle weakness or speech difficulties) first appeared between 12 and 48 months before joining the study
• People who are able to perform a breathing test lying down in a consistent and reliable way, as judged by the study doctor
• People who are taking riluzole and/or edaravone, provided the dose has been stable for at least 4 weeks before screening and will not change during the study — or people who are not taking these medications, provided they do not start them during the study

Who may not be able to join:

• People where other causes of muscle weakness have not been ruled out
• People who have also been diagnosed with another brain or nervous system condition, such as Parkinson's disease or Alzheimer's disease
• People who have used any form of breathing assistance (ventilation) in the 3 months before screening, or who are using it at the time of screening
• People who have used a diaphragm pacing system (a device to help the breathing muscle) within the 3 months before screening
• People who have received any stem cell or gene therapy for ALS
• People with a known allergy or sensitivity to the study drug, levosimendan
• People who have received levosimendan within 3 months before screening, or who have previously taken part in this trial or an earlier related trial (called LEVALS)
• People who have used the medications tirasemtiv or reldesemtiv within 1 month before screening
• People who have taken part in another clinical trial using an experimental treatment within 30 days before screening, or within 5 half-lives of that treatment (whichever is the longer period)
• People who have had botulinum toxin (e.g. Botox) treatment within 3 months before screening
• People with a significant psychiatric diagnosis, notable memory or thinking difficulties, or clear signs of dementia that could affect their ability to follow study procedures
• People with a lung condition such as asthma or COPD that requires regular medication
• People with certain serious heart valve problems, or specific types of heart muscle disease (confirm with trial site)
• People who have been hospitalised for a heart-related event such as a heart attack, heart failure, irregular heartbeat, or stroke within 3 months before screening
• People with a history of a specific dangerous heart rhythm disorder called Torsades de Pointes, or a diagnosed long QT syndrome
• People with a history of life-threatening abnormal heart rhythms, unless a reliable treatment such as an implanted heart device (ICD) or a medical procedure has been used to prevent it recurring
• People with a history of certain types of heart electrical conduction problems (second or third degree AV block, or sinus node disease), unless treated with a pacemaker
• People whose heart rate is consistently above 100 beats per minute when measured at rest during screening
• People whose resting blood pressure (the top number) is below 90 mmHg at screening
• People whose blood potassium level is outside the range of 3.7 to 5.5 mmol/l at screening
• People with severe kidney problems, a high creatinine level in the blood, or who are on dialysis
• People with a blood haemoglobin (iron-carrying protein) level below 10 g/dl, or who have donated blood or lost a significant amount of blood in the 60 days before screening
• People with significant liver problems, as determined by the study doctor
• People with a body mass index (BMI) of 18.5 or below (a measure of weight relative to height)
• Women who are breastfeeding, or women of reproductive age who do not have a negative pregnancy test and who are not committed to using a highly effective form of contraception during the study and for 1 month after the last dose (women who are postmenopausal, surgically sterilised, or have had a hysterectomy are not subject to this requirement)
• People who the study doctor considers to have been actively suicidal in the 3 months before screening
• People with a known history of HIV infection
• People with any other significant medical condition that, in the study doctor's opinion, could affect the study results or pose a health risk to the participant

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