At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of MND (ALS, Primary Lateral Sclerosis, Progressive Muscular Atrophy)
- ✓Age over 18 years
- ✓Negative pregnancy test within 7 days prior to or at baseline visit for women of childbearing potential
- ✓Appropriate contraception from consent to 4 weeks after treatment for women of childbearing potential and fertile men
- ✕Frontotemporal Dementia (FTD-MND) or other significant psychiatric disorder preventing informed consent
- ✕Current alcoholism at investigator's discretion
- ✕Active suicide ideation on Columbia-Suicide Severity Rating Scale
- ✕Concurrent investigational devices and medications including biological therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial
In Brief
A Phase 3 clinical trial evaluating Memantine Hydrochloride Oral Solution, Trazodone Hydrochloride oral solution, and 4 other interventions for Motor Neuron Disease, Amyotrophic Lateral Sclerosis. Currently recruiting, targeting 1,150 participants across 22 sites.
Detailed Summary
MND-SMART is investigating whether selected drugs can slow down the progression of motor neuron disease (MND) and improve survival. The study is 'multi-arm' meaning more than one treatment will be tested at the same time. The trial started with 3 arms; drug 1 (memantine), drug 2 (trazodone) and placebo (dummy drug). A third drug, amantadine, was added in April 2023. A fourth drug, tacrolimus, was added in March 2025 in Edinburgh and across all sites in April 2025. The first two drugs, memantine and trazodone, were removed from the trial in September 2023 due to lack of benefit. The trial currently has 4 recruiting arms; amantadine, liquid placebo (matched to amantadine), tacrolimus, and tablet placebo (matched to tacrolimus). This allows the evaluation of each drug versus placebo. Participants will be randomly allocated between the treatment arms they are eligible for. Medicines being tested are already approved for use in other conditions. MND-SMART has an 'adaptive' design. This means medicines being studied can change according to emerging results. Treatments shown to be ineffective can be dropped and new drugs can be added over the duration of the study. This will allow many treatments, over time, to be efficiently and definitively evaluated. The medicines being tested have been selected following a rigorous process involving a systematic, unbiased, and comprehensive review of past clinical trials data, as well as information from pre-clinical research (studies in laboratories), for MND and other related neurodegenerative disorders. Drugs have been ranked for inclusion in MND-SMART by a group of independent MND experts according to set criteria. These include consideration of how the drugs work, their safety profiles, and the quality of previous studies. New drugs will be selected for investigation in MND-SMART based on continuous review of constantly updated scientific evidence as well as findings from state-of-the-art human stem cell based drug discovery platforms. These can be added by substantial amendment to the protocol.
Study Details
Timeline
Interventions
Memantine hydrocholoride taken once daily
Trazodone Hydrochloride taken once daily
Placebo taken once daily
Amantadine Hydrochloride taken once daily
Tacrolimus 1Mg overencapsulated tablet taken once daily
Placebo taken once daily