Motor Neurone Disease Adaptive Trial Testing Amantadine and Tacrolimus Treatments A Multi-Arm Randomized Study for Adults With ALS and Related Motor Neuron Diseases

What this Trial Is About

Researchers are investigating whether certain approved drugs can slow the progression and improve survival in people with motor neuron disease MND, including amyotrophic lateral sclerosis and related subtypes. This trial uses a multi-arm adaptive design, allowing new drugs to be added and ineffective ones to be dropped over time. The study began with memantine, trazodone, and placebo arms, with amantadine and tacrolimus added later, and the first two drugs removed due to lack of benefit. Participants are randomly assigned to one of several groups, including amantadine, tacrolimus, or matching placebos taken once daily as either oral solutions or capsules. The adaptive approach enables evaluation of each drug against placebo efficiently. The trial started in February 2020 and continues recruiting with ongoing adjustments to treatments based on emerging results. During participation, individuals will be monitored over 18 months with regular assessments including ALS functional rating scales, survival analysis, cognition, respiratory function, clinical staging, anxiety and depression evaluations, quality of life measurements, and safety monitoring. Data collection involves questionnaires and clinical tests to track disease progression and treatment effects, with careful attention to tolerability and adverse events throughout the study period.

Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial