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Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial

Study acronym: MND-SMART
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv10
  2. Primary completion date: Sep 2026 to Dec 2030 Enrollment target: 800 to 1150 · Completion date: Dec 2026 to Dec 2030 · Interventions: Amantadine Hydrochloride Oral Solution (Drug), Memantine Hydrochloride Oral Solution (Drug), Placebo oral solution (Drug), Trazodone… to Amantadine Hydrochloride Oral Solution (Drug), Memantine Hydrochloride Oral Solution (Drug), Placebo capsule (Drug), Placebo oral solution… · 2 morev9 Show 5 more changesShow less
    • Enrollment target: 800 to 1150
    • Completion date: Dec 2026 to Dec 2030
    • Interventions: Amantadine Hydrochloride Oral Solution (Drug), Memantine Hydrochloride Oral Solution (Drug), Placebo oral solution (Drug), Trazodone… to Amantadine Hydrochloride Oral Solution (Drug), Memantine Hydrochloride Oral Solution (Drug), Placebo capsule (Drug), Placebo oral solution…
    • Eligibility criteria expanded, about 300 words
    • Study arms: 4 to 6

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 20 to 22v8
  4. Re-verified, no change to tracked fieldsv7
  5. Study sites: 19 to 20v6
Show 4 earlier versionsHide 4 earlier versions
  1. Enrollment target: 750 to 800 Study sites: 18 to 19 · Interventions: Memantine Hydrochloride Oral Solution (Drug), Placebo oral solution (Drug), Trazodone Hydrochloride oral solution (Drug) to Amantadine Hydrochloride Oral Solution (Drug), Memantine Hydrochloride Oral Solution (Drug), Placebo oral solution (Drug), Trazodone… · Eligibility criteria expanded, about 9 words · 1 morev5 Show 4 more changesShow less
    • Study sites: 18 to 19
    • Interventions: Memantine Hydrochloride Oral Solution (Drug), Placebo oral solution (Drug), Trazodone Hydrochloride oral solution (Drug) to Amantadine Hydrochloride Oral Solution (Drug), Memantine Hydrochloride Oral Solution (Drug), Placebo oral solution (Drug), Trazodone…
    • Eligibility criteria expanded, about 9 words
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 8 to 18 Study description expanded, about 6 wordsv4 Show 1 more changeShow less
    • Study description expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  3. Secondary endpoints: 7 to 6v3 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 1 to 8 Eligibility criteria expanded, about 26 wordsv2 Show 1 more changeShow less
    • Eligibility criteria expanded, about 26 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Edinburgh
100 trials monitored
See 5 trials at risk
ALS
387 trials monitored
See 18 trials at risk
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.
Trial Details
NCT Number NCT04302870
Lead Sponsor University of Edinburgh
Collaborators: University College, London, University of Warwick, NHS Lothian
Conditions Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Enrollment 1,150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov