Experimental MS drug tested in kids, but study halted early
NCT ID NCT03368664
First seen Jun 24, 2026 · Last updated Aug 05, 2026 · Updated 4 times
Summary
This study tested the drug alemtuzumab in children aged 10 to 18 with relapsing-remitting multiple sclerosis (MS) whose disease was still active despite other treatments. The goal was to see if the drug could reduce new brain lesions and improve quality of life. However, the trial was terminated early after enrolling only 16 participants, so the findings are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Alemtuzumab (also known as Lemtrada)
- What this could lead to
- If successful, this could provide a treatment option for children with active MS who have not responded to other therapies.
- What could go wrong
- The trial was terminated early with only 16 participants, so results are limited. Alemtuzumab also carries risks of serious autoimmune reactions and infections.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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16 people
The number who actually took part.
- Started
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Oct 2017
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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10 to 18 years
- 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 : * Participants with RRMS aged from 10 years to \<18 years at study entry was eligible. Participants must meet the criteria of diagnosis of MS as defined by the International Pediatric MS Study Group (IPMSSG) criteria for pediatric MS and the criteria of MS based on 2010 McDonald criteria. * Signed written informed consent/assent obtained from participant and participant's legal representative (parent or guardian) according to local regulations. * Expanded Disability Status Scale (EDSS) score of 0.0 to 5.0 (inclusive) at screening. * At least 2 recorded MS attacks and at least 1 MS attack (relapse) in the last year during treatment with a beta interferon therapy (IFNB) or glatiramer acetate (GA) after being on that therapy for at least 6 months, and was currently still taking the same therapy. * At least 1 of the following: * \>=1 new or enlarging T2 hyperintense lesion or gadolinium enhancing lesion while on that same prior therapy (IFNB or GA), or * Two or more relapses in the prior year, or * Tried at least 2 MS DMTs. Exclusion criteria: * Any progressive or non-relapsing forms of MS. * Conditions/situations such as: * Impossibility to meet specific protocol requirements. * Current participation in another interventional clinical study. Participants who were treated with a comparator agent approved for screening inclusion (INF or GA) may be considered for this trial. * Participant was the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. * Uncooperative participant or any condition that could make the participant potentially non-compliant to the study procedures in the opinion of the Investigator. * Mental condition rendering the participant or parent/guardian unable to understand the nature, scope, and possible consequences of the study. * Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study in the opinion of the Investigator. * History of drug or alcohol abuse. * History of known human immunodeficiency virus (HIV) positivity. * Pregnant or breast-feeding female participants or those who had planned to become pregnant during the study. * Unwilling to agree to use a highly effective contraceptive method when receiving a course of alemtuzumab treatment and for 4 months following that course of treatment (fertile participants only). * Female participants who have commenced menstruating (i.e., are of childbearing potential) and are unwilling or unable to be tested for pregnancy. * Previous treatment with alemtuzumab. * Treatment with natalizumab, daclizumab, fingolimod, methotrexate, azathioprine, cyclosporine, or mycophenolate mofetil in the last 6 months prior to screening, or determined by the treating physician to had residual immune suppression from these or other MS treatments. * Treatment with teriflunomide in the last 12 months except if the participant underwent the recommended elimination procedure as per Summary of Product Characteristics (SmPC). * Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, ocrelizumab, leflunomide, or any cytotoxic therapy. * Previous treatment with any investigational medication (drug that had not been approved at any dose or for any indication). Use of an investigational medication that is subsequently licensed and nonstandard use of a licensed medication (e.g., using a dose other than the dose that is stated in the licensed product labeling or using a licensed therapy for an alternative indication) was not exclusionary. Prior treatment with herbal medications or nutritional supplements was also permitted. * Intolerance of pulsed corticosteroids, especially a history of steroid psychosis. * History of malignancy. * Prior documented history of thrombocytopenia, or platelet count at screening \< lower limits of normal (LLN). * Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS. * Participants with known Type 1 hypersensitivity or anaphylactic reactions to the active substances or any of the excipients, or intolerance of acyclovir or its therapeutic equivalent. * Major systemic disease or other illness that would, in the opinion of the Investigator, compromise participant safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease, or other conditions that might predispose to hemorrhage, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis. * Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the participant's ability to understand the participant information, to give informed consent, to comply with the trial protocol, or to complete the study. * Major psychiatric disorder that is not adequately controlled by treatment in the opinion of the Investigator. * Epileptic seizures that are not adequately controlled by treatment. * Magnetic resonance imaging (MRI)-related conditions: conditions that could interfere with MRI acquisition and/or interpretation of MRI results (eg, claustrophobia, orthopedic implants/treatments, orthodontic treatments etc). * Known bleeding disorder (e.g., dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, clotting factor deficiency). * Prior history of invasive fungal infections. * Active infection, eg, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation. * In the Investigator's opinion, participant is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection). The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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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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Investigational Site Number : 2500001
Le Kremlin-Bicêtre, 94270, France
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Investigational Site Number : 2500002
Strasbourg, 67000, France
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Investigational Site Number : 3800004
Naples, Napoli, 80131, Italy
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Investigational Site Number : 3800005
Cagliari, 09126, Italy
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Investigational Site Number : 6160002
Poznan, Greater Poland Voivodeship, 60-780, Poland
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Investigational Site Number : 6160003
Lodz, Lódzkie, 93-338, Poland
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Investigational Site Number : 6430001
Moscow, 119602, Russia
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Investigational Site Number : 6430002
Saint Petersburg, 197110, Russia
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Investigational Site Number : 6430004
Moscow, 129110, Russia
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Investigational Site Number : 6430005
Saint Petersburg, 197022, Russia
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Investigational Site Number : 7920001
Ankara, 06560, Turkey (Türkiye)
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Investigational Site Number : 7920003
Istanbul, 34093, Turkey (Türkiye)
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Investigational Site Number : 8260002
London, London, City of, WC1N 3JH, United Kingdom
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