Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Smart trial takes on MND: could existing drugs slow the disease?

NCT ID NCT04302870

Disease control Sponsor: University of Edinburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests several already-approved drugs to see if they can slow down motor neuron disease (MND) and help people live longer. About 1150 adults with MND will be randomly assigned to receive one of the study drugs or a placebo. The trial uses a flexible design, allowing ineffective drugs to be dropped and new ones added over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 1,150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Motor neuron disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis lateral sclerosis motor neuron disorder progressive muscular atrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Motor neuron disease, amyotrophic lateral sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aberdeen Royal Infirmary

    RECRUITING

    Aberdeen, United Kingdom

  • Anne Rowling Regenerative Neurology Clinic

    RECRUITING

    Edinburgh, EH16 4SB, United Kingdom

  • Cambridge University Hospitals NHS Foundation Trust

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Cardiff and Vale University Local Health Board

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Clinical Research Centre , Ninewells Hospital

    RECRUITING

    Dundee, United Kingdom

  • Clinical Research Facility Salford Royal NHS Foundation Trust

    RECRUITING

    Salford, United Kingdom

  • Clinical Research Facility University Hospital Southampton

    RECRUITING

    Southampton, United Kingdom

  • East Suffolk and North Essex NHS Foundation Trust

    RECRUITING

    Ipswich, CO4 5JL, United Kingdom

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • NHS Highland Clinical Research Facility, Raigmore Hospital

    RECRUITING

    Inverness, United Kingdom

  • Newcastle upon Tyne Hospitals NHS Foundation Trust

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    RECRUITING

    Norwich, NR4 7UY, United Kingdom

  • Queen Elizabeth University Hospital Clinical Research Facility

    RECRUITING

    Glasgow, United Kingdom

  • Royal Devon and Exeter Hospital

    RECRUITING

    Exeter, United Kingdom

  • Royal London Hospital

    RECRUITING

    London, E1 1FR, United Kingdom

  • Sheffield Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Sheffield, United Kingdom

  • Southern Health and Social Care Trust, Craigavon Area Hospital

    RECRUITING

    Portadown, County Armagh, BT63 5QQ, United Kingdom

  • St George's University Hospitals NHS Foundation Trust

    RECRUITING

    London, SW17 0QT, United Kingdom

  • University Hospitals Sussex NHS Foundation Trust

    RECRUITING

    Brighton, United Kingdom

  • University Hospitals of Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • University Hospitals of Dorset NHS Trust

    RECRUITING

    Poole, United Kingdom

  • West Suffolk NHS Foundation Trust

    RECRUITING

    Bury St Edmunds, IP33 2QZ, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.