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New treatment option for Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Official title Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial
ClinicalTrials.gov ID: NCT04302870
What this study is testing
What is Memantine Hydrochloride Oral Solution?
Memantine Hydrochloride Oral Solution is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for motor neuron disease, amyotrophic lateral sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants will be considered eligible for randomisation if they fulfil all the core and none of the
You likely can't join if
- as defined below. In addition, investigators must simultaneously check and ensure participants do not meet any of the drug specific exclusion...
- Confirmed diagnosis of MND. This includes the following subtypes: ALS by El Escorial Criteria (possible, probable, and definite) or Gold Coast...
- 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...
- Willing and able to comply with the trial protocol and ability to understand and complete questionnaires
See the full eligibility criteria
- Participants will be considered eligible for randomisation if they fulfil all the core and none of the
- 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...
- 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...
- 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 \ 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Portadown, County Armagh, United Kingdom
- Aberdeen, United Kingdom
- Birmingham, United Kingdom
- Brighton, United Kingdom
- Bury St Edmunds, United Kingdom
- Cambridge, United Kingdom
- Cardiff, United Kingdom
- Dundee, United Kingdom
- Edinburgh, United Kingdom
- Exeter, United Kingdom
- Glasgow, United Kingdom
- Inverness, United Kingdom
- Ipswich, United Kingdom
- London, United Kingdom
- Newcastle upon Tyne, United Kingdom
- Norwich, United Kingdom
- Poole, United Kingdom
- Salford, United Kingdom
- Sheffield, United Kingdom
- Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portadown, County Armagh, United Kingdom; Aberdeen, United Kingdom; Birmingham, United Kingdom; Brighton, United Kingdom; Bury St Edmunds, United Kingdom; Cambridge, United Kingdom and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.