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Looking for participantsPhase2/Phase3

Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial

Sponsor: University of Edinburgh

NCT ID: NCT04302870

View on ClinicalTrials.gov ↗

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/

Motor Neuron Disease, Amyotrophic Lateral Sclerosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

have a negativeeGFR

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
Participants will be considered eligible for randomisation if they fulfil all the core inclusion criteria and none of the exclusion criteria as defined below. In addition, investigators must simultaneously check and ensure participants do not meet any of the drug specific exclusion criteria. If exclusion criteria are met for an arm, participants can still be considered for other arms and randomised accordingly to eligible arms. Core inclusion criteria: * Confirmed diagnosis of MND. This includes the following subtypes: ALS by El Escorial Criteria (possible, probable, and definite) or Gold Coast Criteria, Primary Lateral Sclerosis, and Progressive Muscular Atrophy * Over 18 * Women of childbearing potential according to CTFG guidelines must have a negative pregnancy test within 7 days prior to, or at, the baseline visit * Women of childbearing potential and fertile men must be using an appropriate method of contraception to avoid any unlikely teratogenic effects of the selected drugs from time of consent, to 4 weeks after treatment inclusive * Willing and able to comply with the trial protocol and ability to understand and complete questionnaires * Written informed consent (in the case of limb dysfunction verbal consent can be given in the presence of a witness who can sign) Core Exclusion Criteria: * Patients diagnosed with Frontotemporal Dementia (FTD-MND) or any other significant psychiatric disorder that prevents informed consent being given. * 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 * If ALT, ALP, bilirubin or GGT \>3 times the upper limit of normal. * If creatinine clearance (creatinine clearance or eGFR) \<35 ml/min. * If TSH \<0.2mU/l (if possible to test free T4, then Serum free T4 \>25pmol/l) * If corrected QT interval on 12 lead ECG \>500 ms * Patient's diagnosed with ventricular arrhythmias, significant heart block (at the investigator's discretion)) or in the immediate recovery period after myocardial infarction (\< 6 weeks). * Patients who the PI considers will not be able to comply with the study protocol. Amantadine Exclusion Criteria: * Patients in the manic phase of bipolar disorder. * Patients with history of proven peptic ulcer confirmed on endoscopy * Patients with active epilepsy * Already taking the IMP in this comparison * Known hypersensitivity, including hereditary fructose intolerance, or adverse reaction to the active substances and their excipients (as per SPCs for this comparison) or any past medical history contraindicating use of the IMP in this comparison Tacrolimus Exclusion Criteria: * Poorly controlled hypertension (Systolic BP\>180 mmHg or Diastolic BP\>100mmHg) * Poorly controlled diabetes (HbA1c\>6.4% or 48mmol/mol) * Hypertrophic cardiomyopathy or history of QT prolongation (including family history), congestive heart failure, bradyarrhythmias, and electrolyte abnormalities * History of bleeding disorders or significant haematological or immune diseases including, congenital or acquired immune deficiency, anaemia (Hb\<130g/L for males and Hb\<120 g/L in females) and thrombocytopenia (platelet count \<150 × 109/L), use of other biological agents and immunosuppressant medications including oral/IV steroids * Active or chronic infection (at PI discretion) * History of Hepatitis B or C * History of lymphoma and active malignancy * Risk of dehydration due to reduced oral intake and lack of parenteral route * Patient's contraindicated to tacrolimus according to SPC section 4.3 * Use of concomitant medications that interacts with tacrolimus according to the SPC, including but not limited to strong CYP3A4 inhibitors (i.e. azoles, protease inhibitors) or CYP3A4 inducers (rifampicin, phenytoin, carbamazepine), barbiturates, macrolides, digoxin, statins, PPI inhibitors, ergotamine, tricyclic antidepressants, herbal supplements (St. John's wort, extracts of Schisandra sphenanthera) * Inability to swallow capsules * Already taking the IMP in this comparison * Known hypersensitivity, including lactose and gelatin intolerance, or adverse reaction to the active substances and their excipients (as per SPCs for this comparison) or any past medical history contraindicating use of the IMP in this comparison * Receipt of a live attenuated vaccine within four weeks prior to receipt of tacrolimus. These include, but are not limited to live influenza vaccine (Fluenz Tetra), Shingles (varicella zoster virus) Zostavax, Varicella (Varilrix, Varilvax), Oral typhoid (Ty21a), and yellow fever vaccines.

Where Is This Study? (22 UK sites)

Southern Health and Social Care Trust, Craigavon Area Hospital

Portadown BT63 5QQ, United Kingdom

Recruiting

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

University Hospitals of Birmingham NHS Foundation Trust

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom

Recruiting
Site contact (verified)
Andrew BarrittPrincipal Investigator

West Suffolk NHS Foundation Trust

Bury St Edmunds IP33 2QZ, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&D Co-ordinator.

R&D@WSH.nhs.uk01284 712790

Cambridge University Hospitals NHS Foundation Trust

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Cardiff and Vale University Local Health Board

Cardiff CF14 4XW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Martin

research.development@wales.nhs.uk029 2074 6986

Clinical Research Centre , Ninewells Hospital

Dundee, United Kingdom

Recruiting

Anne Rowling Regenerative Neurology Clinic

Edinburgh EH16 4SB, United Kingdom

Recruiting
Site contact (verified)

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Recruiting
Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

Queen Elizabeth University Hospital Clinical Research Facility

Glasgow, United Kingdom

Recruiting

NHS Highland Clinical Research Facility, Raigmore Hospital

Inverness, United Kingdom

Recruiting

East Suffolk and North Essex NHS Foundation Trust

Ipswich CO4 5JL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Frances Farnworth

R&D@esneft.nhs.uk01473 704787

Royal London Hospital

London E1 1FR, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

St George's University Hospitals NHS Foundation Trust

London SW17 0QT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

King's College Hospital NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)
Ammar Al-ChalabiPrincipal Investigator

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich NR4 7UY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611

University Hospitals of Dorset NHS Trust

Poole, United Kingdom

Recruiting
Site contact (verified)
Charles HillierPrincipal Investigator

Clinical Research Facility Salford Royal NHS Foundation Trust

Salford, United Kingdom

Recruiting

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Clinical Research Facility University Hospital Southampton

Southampton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

How to Get in Touch

Professor Chandran

Sponsor contact

CONTACT

0131 465 9612 siddharthan.chandran@ed.ac.uk

Amy Stenson

Sponsor contact

CONTACT

0131 242 9122 astenson@exseed.ed.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-03