Could a short pill course save hand function in advanced MS?
NCT ID NCT04695080
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
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204 people
The number who actually took part.
- Started
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Jun 2021
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Aneurin Bevan University Health Board
Newport, NP20 2UB, United Kingdom
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Anne Rowling Clinic, University of Edinburgh
Edinburgh, EH16 4SB, United Kingdom
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Cardiff University Hospital
Cardiff, CF14 4XW, United Kingdom
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Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX, United Kingdom
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Lewisham and Greenwich NHS Trust
London, SE13 6LH, United Kingdom
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Luton and Dunstable Hospital
Luton, LU4 0DZ, United Kingdom
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Morriston Hospital, Swansea
Swansea, SA6 6NL, United Kingdom
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Nottingham University Hospital (Nottingham University Hospitals NHS Trust)
Nottingham, NG7 2UH, United Kingdom
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Queen Elizabeth University Hospital Glasgow
Glasgow, G51 4TF, United Kingdom
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Queen's Hospital (Havering and Redbridge University Hospitals NHS Trust)
London, RM7 0AG, United Kingdom
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Queens University Belfast (Belfast Health and Social Care Trust)
Belfast, BT12 6BA, United Kingdom
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Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
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Royal London Hospital
London, E1 1FR, United Kingdom
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Salford Royal Hospital NHS Trust
Manchester, M6 8HD, United Kingdom
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Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF, United Kingdom
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St George's University Hospitals NHS Foundation Trust
London, SW17 0RE, United Kingdom
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University Hospital Hairmyres, NHS Lanarkshire
Glasgow, G75 8RG, United Kingdom
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University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
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University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH, United Kingdom
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University Hospitals of Coventry and Warwickshire NHS Trust
Coventry, CV2 2DX, United Kingdom
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University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, ST4 6QG, United Kingdom
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Walton Centre NHS Trust
Liverpool, L9 7LJ, United Kingdom
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