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Study identifier: NCT04302870 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial

Condition: Motor Neuron Disease, Amyotrophic Lateral Sclerosis  ·  Sponsor: University of Edinburgh

PhasePhase 2/Phase 3
Planned participants1150
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 labo…

This description comes directly from the study's public registry record.

Talk to the study team

Professor Chandran  ·  0131 465 9612  ·  siddharthan.chandran@ed.ac.uk

Amy Stenson  ·  0131 242 9122  ·  astenson@exseed.ed.ac.uk

Always discuss trial participation with your own doctor first.

Locations (22)

Southern Health and Social Care Trust, Craigavon Area HospitalPortadown, County Armagh, United KingdomRecruiting
Aberdeen Royal InfirmaryAberdeen, United KingdomRecruiting
University Hospitals of Birmingham NHS Foundation TrustBirmingham, United KingdomRecruiting
University Hospitals Sussex NHS Foundation TrustBrighton, United KingdomRecruiting
West Suffolk NHS Foundation TrustBury St Edmunds, United KingdomRecruiting
Cambridge University Hospitals NHS Foundation TrustCambridge, United KingdomRecruiting
Cardiff and Vale University Local Health BoardCardiff, United KingdomRecruiting
Clinical Research Centre , Ninewells HospitalDundee, United KingdomRecruiting
Anne Rowling Regenerative Neurology ClinicEdinburgh, United KingdomRecruiting
Royal Devon and Exeter HospitalExeter, United KingdomRecruiting
Queen Elizabeth University Hospital Clinical Research FacilityGlasgow, United KingdomRecruiting
NHS Highland Clinical Research Facility, Raigmore HospitalInverness, United KingdomRecruiting

+ 10 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04302870