Can a pill calm the immune attack in MS? a trial looks inside the spinal fluid
NCT ID NCT03963375
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial tests whether cladribine tablets change key immune cells and nerve damage markers in the spinal fluid of people with relapsing forms of multiple sclerosis. Participants take cladribine as prescribed and undergo up to two lumbar punctures to measure these biomarkers over two years. The goal is to better understand how the drug works inside the central nervous system.
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
- What this could lead to
- If it works, this could clarify how cladribine calms the immune attack on the brain and spinal cord in multiple sclerosis.
- What could go wrong
- This is a small, early-phase biomarker study, not designed to prove clinical benefit. The results may not translate into better outcomes for patients.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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47 people
The number who actually took part.
- Started
-
Oct 2019
- Finished
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May 2025
- 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
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18 to 65 years
- Sex
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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 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. Have a relapsing form of multiple sclerosis (RMS; to include RRMS or active secondary progressive MS) 2. Are willing and able to receive at least 2 lumbar punctures 3. Have an EDSS of 0 to ≤ 5.5 during the screening period 4. Had at least 1 relapse or 1 gadolinium-enhancing or 1 new or enlarged T2 lesion in the last 12 months 5. Have absolute lymphocyte count (ALC) within normal range of the local laboratory or assessed as normal by the investigator within the 3 week screening period and meet all other eligibility criteria for cladribine tablet treatment 6. Capable of giving signed informed consent Exclusion Criteria: 1. Have any contraindication for lumbar puncture 2. Have current malignancy 3. Are infected with human immunodeficiency virus (HIV) 4. Have active chronic infections (e.g. hepatitis or tuberculosis) 5. Have signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML) in MRI 6. Have history of hypersensitivity to cladribine or any of the excipients listed in the cladribine tablets US Prescribing Information 7. Allergy or hypersensitivity to gadolinium and/or any other contraindication to perform a MRI 8. Have any other comorbid conditions that preclude participation 9. Have been previously treated with cladribine 10. Have previously been treated with ocrelizumab, alemtuzumab, rituximab, or daclizumab 11. Have received treatment with natalizumab during the last 6 months 12. Are currently receiving immunosuppressive or myelosuppressive therapy, e.g., methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic treatment with systemic corticosteroids 13. Have received treatment with immunosuppressive or myelosuppressive therapy during the last 6 months 14. Have received chronic treatment with systemic corticosteroids during the last 4 weeks 15. Have moderate or severe hepatic impairment (Child-Pugh score \>6) 16. Have moderate or severe renal impairment (creatinine clearance \<60 mL per minute) 17. Are pregnant or unwilling or unable to use effective contraception during cladribine tablets dosing and for 6 months after the last dose in each treatment course 18. Are intending to breastfeed on a cladribine tablet treatment day and/or during the 10 days after the last cladribine tablet dose.
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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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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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