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Could a short pill course save hand function in advanced MS?

NCT ID NCT04695080

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This UK trial tests whether cladribine tablets, taken for just 8-10 days a year over two years, can slow the loss of hand function in people with advanced multiple sclerosis (MS). The study includes 204 participants with significant disability (EDSS 6.5-8.5). Half receive cladribine, half a placebo, and researchers measure hand speed and dexterity after two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cladribine tablets (Mavenclad)
What this could lead to
If it works, this could offer a short-course treatment to slow disability and preserve hand function in people with advanced MS.
What could go wrong
This is a mid-stage trial with only 204 participants. Cladribine is not yet proven for advanced MS, and risks include immune suppression and infection.

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

204 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Dec 2027

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.

Inclusion criteria: 1. pwAMS aged 18+ years with an EDSS of 6.5-8.5 (inclusive) 2. History of bowel cancer screening for men, and women and cervical and breast cancer screening for women as per NHS recommended guidelines https://www.nhs.uk/conditions/nhs-screening/. 3. Ability to complete the 9HPT with at least one upper limb within 180 seconds. The average score of both attempts for each hand should be used to assess eligibility. 4. Confirmation of MS diagnosis according to the McDonald Criteria (2017) Thompson et al. 2018). 5. In the judgement of the investigator, evidence of deterioration of upper limb function during the 2 years running up to the screening date. Exclusion Criteria 1. Participants with known hypersensitivity to Cladribine of any grade (as per CTCAE grading system) should be excluded 2. Any uncontrolled diabetes, arterial hypertension and hypercholesterolaemia as determined by PI or delegated sub-investigator 3. A history of stroke and/or myocardial infarction 4. Moderate to severe renal impairment (creatinine clearance \<60 ml/min) 5. Moderate to severe hepatic impairment (Child-Pugh score \>6) 6. Significant comorbidity, e.g. cardiac failure, renal failure, malignancy, or other health condition that in the view of the PI or delegated sub-investigator precludes participation. Patients who, following discussion with their cancer treatment team, are deemed to be cured from malignancy, may be eligible to participate as per the clinical judgement of the local PI. 7. Pregnancy including planning to father a child or breastfeeding 8. Body weight less \<40kg 9. Unwillingness to use effective contraception throughout the trial period until at least six months after the last administration of IMP. This is not applicable for post-menopausal women 10. Acute infection (uncontrolled) 11. Infection with Human Immunodeficiency Virus 1 and/or 2 12. Active chronic infection (Syphilis, Tuberculosis, Hepatitis). Patients with active TB will be excluded. However, patients who have a positive IGRA, Elispot or Quantiferon test, but exhibit no symptoms for TB and evidence of a normal Chest X Ray, can be included in the study as per judgement of the local PI and after clarification with the CI. 13. Precancerous condition 14. Total lymphocyte count \<1.0\*109/L 15. Seronegativity for varicella zoster virus. Potential participants who are IgG negative may undergo vaccination, and can be screened again once full course has been completed. Seronegativity for all of the following: measles, mumps, rubella. Potential participants who are IgG negative for all 3 viruses, may undergo vaccination and can be screened again once full course has been completed. 16. Relapse within six months before screening 17. Inability to complete an MRI (contraindications for MRI, including but not limited to, MRI-non-compatible pacemaker, cochlear implants, intracranial vascular clips, surgery within 6 weeks of entry in the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, severe anxiety or claustrophobia etc.) or contraindication to Gd administration. 18. Treatment with steroids due to MS relapse/progression within three months of screening. pwAMS who fall in this category may undergo a further screening visit once the three months' window has expired and may be included if no steroid treatment has been administered in the intervening period. If for any reason a participant is unable to have a baseline MRI scan (due for safety reasons), this MRI scan may be omitted and a recent 'historical' MRI scan (collected within the 3 months preceding the first IMP dose dispensing at Baseline visit) can be used at the CI's discretion. This will need to be assessed by the CI case by case basis. The review of the historical MRI scan to exclude PML should be clearly documented in the subject's electronic health records prior to the first IMP dose dispensing at Baseline visit. 19. Treatment with any interferon-beta, glatiramer acetate, teriflunomide, leflunomide or dimethyl-fumarate within three months before screening. 20. Treatment with natalizumab, fingolimod, siponimod, ponesimod, ozanimod (or other Sphingosine-1-phosphate receptor modulators) within three months of screening. 21. Treatment with azathioprine, methotrexate, or cyclosporine within six months before screening. 22. pwAMS treated with teriflunomide will need to undergo accelerated elimination of the compound before being considered (Research and Case Medical Research 2019). 23. Treatment with haematopoietic stem cell transplantation (HSCT), mitoxantrone, cyclophosphamide, cladribine, alemtuzumab, or another B cell depleting compound, such as rituximab, ocrelizumab, ublitiuximab, ofatumumab, or biosimilars, unless the participant concerned has a memory B cell level of ≥20% of the CD19+ population in the peripheral blood. Such a level would normally not be expected earlier than a minimum of six months after the last drug administration. Participants who underwent such treatment will therefore have to be tested for their CD19+/CD27+ memory B cell level at screening. 24. Treatment with fampridine: If they are already on treatment for at least one month, participants should continue throughout the trial. However, starting continuous fampridine treatment after signing the consent sheet will lead to exclusion from treatment with IMP/placebo. 25. Concurrent participation or previous participation within the last 6 months in another clinical trial of an IMP or medical device. 26. Unable to swallow tablets

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Aneurin Bevan University Health Board

    Newport, NP20 2UB, United Kingdom

  • Anne Rowling Clinic, University of Edinburgh

    Edinburgh, EH16 4SB, United Kingdom

  • Cardiff University Hospital

    Cardiff, CF14 4XW, United Kingdom

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS1 3EX, United Kingdom

  • Lewisham and Greenwich NHS Trust

    London, SE13 6LH, United Kingdom

  • Luton and Dunstable Hospital

    Luton, LU4 0DZ, United Kingdom

  • Morriston Hospital, Swansea

    Swansea, SA6 6NL, United Kingdom

  • Nottingham University Hospital (Nottingham University Hospitals NHS Trust)

    Nottingham, NG7 2UH, United Kingdom

  • Queen Elizabeth University Hospital Glasgow

    Glasgow, G51 4TF, United Kingdom

  • Queen's Hospital (Havering and Redbridge University Hospitals NHS Trust)

    London, RM7 0AG, United Kingdom

  • Queens University Belfast (Belfast Health and Social Care Trust)

    Belfast, BT12 6BA, United Kingdom

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • Royal London Hospital

    London, E1 1FR, United Kingdom

  • Salford Royal Hospital NHS Trust

    Manchester, M6 8HD, United Kingdom

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2JF, United Kingdom

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0RE, United Kingdom

  • University Hospital Hairmyres, NHS Lanarkshire

    Glasgow, G75 8RG, United Kingdom

  • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH, United Kingdom

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH, United Kingdom

  • University Hospitals of Coventry and Warwickshire NHS Trust

    Coventry, CV2 2DX, United Kingdom

  • University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • Walton Centre NHS Trust

    Liverpool, L9 7LJ, United Kingdom

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