At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Memantine Hydrochloride Oral Solution (drug), Trazodone Hydrochloride oral solution (drug), Placebo oral solution (drug), Amantadine Hydrochloride Oral Solution (drug)
- How long the study runs
- Study runs about 130 months (dates as stated)
- About the drug or intervention
- Memantine Hydrochloride Oral Solution — drug: Memantine hydrocholoride taken once daily · Trazodone Hydrochloride oral solution — drug: Trazodone Hydrochloride taken once daily · Placebo oral solution — drug: Placebo taken once daily · Amantadine Hydrochloride Oral Solution — drug: Amantadine Hydrochloride taken once daily · Tacrolimus 1Mg Cap — drug: Tacrolimus 1Mg overencapsulated tablet taken once daily · Placebo capsule — drug: Placebo taken once daily
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,150
- Started
- 2020-02-27
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for motor neuron disease, amyotrophic lateral sclerosis
- • Phase2/Phase3 - 1,150 participants
- • MND-SMART is investigating whether selected drugs can slow down the progression of motor neuron disease (MND) and improve survival
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with motor neuron disease, amyotrophic lateral sclerosis
Where?
- • Portadown - Southern Health and Social Care Trust, Craigavon Area Hospital
- • Aberdeen - Aberdeen Royal Infirmary
- • Birmingham - University Hospitals of Birmingham NHS Foundation Trust
- • Brighton - University Hospitals Sussex NHS Foundation Trust
- • +18 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
For further information, please visit: https://mnd-smart.org/
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative pregnancy test within 7 days
What the study is looking for
- ✓Over 18
- ✓Women of childbearing potential according to CTFG guidelines must have a negative pregnancy test within 7 days prior...
- ✓Willing and able to comply with the trial protocol and ability to understand and complete questionnaires
- ✓Written agreement to take part (in the case of limb dysfunction verbal consent can be given in the presence of a witness...
Who cannot take part
- ✗Patients diagnosed with Frontotemporal Dementia (FTD-MND) or any other significant psychiatric disorder that...
- ✗Alcoholism (current self-reported - at the investigator's discretion)
- ✗Active suicide ideation assessed using the Columbia-Suicide Severity Rating Scale
- ✗On concurrent investigational devices and medication (including biological therapy)
- ✗Pregnancy or breast-feeding females
See the full criteria
Where Is This Study? (22 UK sites)
Southern Health and Social Care Trust, Craigavon Area Hospital
Portadown BT63 5QQ, United Kingdom
Rachelle Moore
research.office@southerntrust.hscni.net028 3756 3755 Extension: 63755Aberdeen Royal Infirmary
Aberdeen, United Kingdom
University Hospitals of Birmingham NHS Foundation Trust
Birmingham B15 2TH, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom
West Suffolk NHS Foundation Trust
Bury St Edmunds IP33 2QZ, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 0QQ, United Kingdom
Cardiff and Vale University Local Health Board
Cardiff CF14 4XW, United Kingdom
Clinical Research Centre , Ninewells Hospital
Dundee, United Kingdom
Anne Rowling Regenerative Neurology Clinic
Edinburgh EH16 4SB, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Queen Elizabeth University Hospital Clinical Research Facility
Glasgow, United Kingdom
NHS Highland Clinical Research Facility, Raigmore Hospital
Inverness, United Kingdom
East Suffolk and North Essex NHS Foundation Trust
Ipswich CO4 5JL, United Kingdom
Royal London Hospital
London E1 1FR, United Kingdom
St George's University Hospitals NHS Foundation Trust
London SW17 0QT, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne NE7 7DN, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich NR4 7UY, United Kingdom
University Hospitals of Dorset NHS Trust
Poole, United Kingdom
Clinical Research Facility Salford Royal NHS Foundation Trust
Salford, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Clinical Research Facility University Hospital Southampton
Southampton, United Kingdom
How to Get in Touch
Professor Chandran
Sponsor contactCONTACT
Amy Stenson
Sponsor contactCONTACT
