Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial (MND-SMART)
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|ClinicalTrials.gov Identifier: NCT04302870|
Recruitment Status : Recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
MND-SMART is investigating whether selected drugs can slow down the progression of motor neurone disease (MND) and improve survival.
The study is 'multi-arm' meaning more than one treatment will be tested at the same time. In the first instance the trial will have 3 arms; drug 1, drug 2 and placebo (dummy drug). This allows the evaluation of drug 1 versus placebo and separately drug 2 versus placebo. Participants will be randomly allocated to either drug 1, drug 2 or placebo. 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 first 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.
|Condition or disease||Intervention/treatment||Phase|
|Motor Neuron Disease, Amyotrophic Lateral Sclerosis||Drug: Memantine Hydrochloride Oral Solution Drug: Trazodone Hydrochloride oral solution Drug: Placebo oral solution||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial|
|Actual Study Start Date :||February 27, 2020|
|Estimated Primary Completion Date :||September 2026|
|Estimated Study Completion Date :||December 2026|
Drug: Memantine Hydrochloride Oral Solution
Memantine hydrocholoride taken once daily
Drug: Trazodone Hydrochloride oral solution
Trazodone Hydrochloride taken once daily
|Placebo Comparator: Placebo||
Drug: Placebo oral solution
Placebo taken once daily
- Change in decline of ALS-FRS(R) over 18months [ Time Frame: 18 months ]Co-primary outcome measure
- Survival [ Time Frame: 18 months ]Co-primary outcome measure
- Cognition and behaviour [ Time Frame: 18 months ]Using Edinburgh Cognitive and Behavioural ALS Screen (ECAS)
- Respiratory function - Forced vital capacity [ Time Frame: 18 months ]Change in FVC
- King's ALS Clinical stage [ Time Frame: 18 months ]Time to reach King's stage IV, scale range I - V
- Changes in anxiety and depression [ Time Frame: 18 months ]Measured using the hospital anxiety and depression scale (HADS), scale range 0 - 42
- Changes in Quality of Life [ Time Frame: 18 months ]Measured using EQ-5D-5L
- Safety and tolerability of IMPs [ Time Frame: 18 months ]Measured using adverse events
- Respiratory function - Sniff nasal inspiratory pressure [ Time Frame: 18 months ]Change in SNIP
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302870
|Contact: Professor Chandran||0131 465 email@example.com|
|Contact: Rachel Dakin||0131 465 9612||rachel.dakin@Ed.ac.uk|
|Anne Rowling Regenerative Neurology Clinic||Recruiting|
|Edinburgh, United Kingdom, EH16 4SB|
|Contact: Judith Newton 0131 242 7985 firstname.lastname@example.org|
|Study Director:||Professor Chandran||University of Edinburgh|