Children With Multiple SclerosisREMYELIKIDSNCT05258396
Exploring Cortical Remyelination in Children With Multiple Sclerosis
A study testing MRI without injection of contrast product in people with Children With Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Multiple Sclerosis
- What is being tested?
- MRI without injection of contrast product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Aug 2022to 11 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age between 12 years old and 18 years old
- RR-MS defined by 2017 McDonald criteria
- no relapse the last 4 weeks
- no methylprednisolone or prednisolone the last 4 weeks.
- affiliated to the social security system
- signature of the consent by the 2 holders of parental authority
Show all 9Show fewer
- age between 12 years old and 18 years old
- absence of any neurological
- signature of the consent by the 2 holders of parental authority
Who cannot join
- Parental rejection
- Contre-indication of brain MRI: pace maker, tatoo of the face, claustrophobia….
- Pregnancy, copper intrauterine device
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Service de Neurologie Pédiatrique, Hôpital du Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270
Kumaran Deiva, MD, 01 45 21 31 12 ext. +33, kumaran.deiva@aphp.fr
- Recruiting
CIC Neurosciences - Pitié Salpêtrière
Paris, 75013
Elisabeth Maillart, MD, 01 42 16 19 75 ext. +33, elisabeth.maillart@aphp.fr
Elisabeth Maillart, MD
- Not yet recruiting
Service de Neurologie, GH Pitié Salpêtrière
Paris, 75013
Elisabeth Maillart, MD, 01 42 16 19 75 ext. +33, elisabeth.maillart@aphp.fr
About this study
Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo.
Read the detailed description
Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo.
The investigator team has performed a first study to generate for the first time magnetization transfer ratio (MTR)-based maps of cortical myelin repair in 15 adult patients with MS. The team found that patients with MS showed a high variability in cortical myelin repair, with variable index of cortical remyelination. Moreover, there was a significant correlation between the index of cortical remyelination and clinical scores.
Even if childhood onset MS take longer to reach states of irreversible disability, severe disability will eventually occur at a young age. Moreover, pediatric MS could be responsible for cognitive disorders.
It is therefore of crucial relevance to develop research programs designed to generate novel imaging techniques to measure the efficacy of remyelinating therapies. Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo.
The team has performed a first study to generate for the first time magnetization transfer ratio (MTR) - based maps of cortical myelin repair in 15 adult patients with MS. The investigator team found that patients with MS showed a high variability in cortical myelin repair, with variable index of cortical remyelination. Moreover, there was a significant correlation between the index of cortical remyelination and clinical scores.
Even if childhood onset MS take longer to reach states of irreversible disability, severe disability will eventually occur at a young age. Moreover, pediatric MS could be responsible for cognitive disorders.
It is therefore of crucial relevance to develop research programs designed to generate novel imaging techniques to measure the efficacy of remyelinating therapies.
Finally, another extremely challenging issue in the care of children with MS is the difficulty of the transition between pediatric and adult care. Over last years, at the Pitié-Salpêtrière Hospital, the neurology team created a transition program called JUMP to improve medical, educational and psychosocial outcome for adolescent patients with MS .Taking part in the present study, young patients from 16 to 18 years old could have a direct access to the JUMP program, with the coordination of the dedicated nurses.
- Conditions
- Children With Multiple Sclerosis
- Being tested
- MRI without injection of contrast product
- Keywords
- MRI, MS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI without injection of contrast productOther
MRI without injection of contrast product
| Study group | Role | What they receive |
|---|---|---|
| Patients with MS | Experimental | Children with MS Receives: Other: MRI without injection of contrast product |
| Volunteers | Experimental | matched in age and sex with patients. Volunteers will perform only one brain MRI, as requested by the neurologist Receives: Other: MRI without injection of contrast product |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTR-based individual indices
To investigate the association between MTR-based individual indices of cortical myelin repair in children with MS and one cognitive score (Symbol Digital Modalities Test (SDMT)) at baseline
Measured: 1 day
Secondary outcomes (1)
indices of cortical remyelination
To investigate the association between individual indices of cortical remyelination and neurological disability
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start11 Aug 2022
- Primary completion11 Sep 2026 (estimated)
- Study completion11 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258396
- Sponsor's protocol ID
- APHP210916
- Other IDs
- 2021-A02792-39
- Acronym
- REMYELIKIDS
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Cortical Remyelination in Children With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05258396
- Acronym / sponsor ID
- REMYELIKIDS / APHP210916
- Conditions
- Children With Multiple Sclerosis
- Keywords
- MRI, MS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 11 Sep 2026 (estimated)
- Study completion
- 11 Sep 2026 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo.
Detailed description
Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo.
The investigator team has performed a first study to generate for the first time magnetization transfer ratio (MTR)-based maps of cortical myelin repair in 15 adult patients with MS. The team found that patients with MS showed a high variability in cortical myelin repair, with variable index of cortical remyelination. Moreover, there was a significant correlation between the index of cortical remyelination and clinical scores.
Even if childhood onset MS take longer to reach states of irreversible disability, severe disability will eventually occur at a young age. Moreover, pediatric MS could be responsible for cognitive disorders.
It is therefore of crucial relevance to develop research programs designed to generate novel imaging techniques to measure the efficacy of remyelinating therapies. Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo.
The team has performed a first study to generate for the first time magnetization transfer ratio (MTR) - based maps of cortical myelin repair in 15 adult patients with MS. The investigator team found that patients with MS showed a high variability in cortical myelin repair, with variable index of cortical remyelination. Moreover, there was a significant correlation between the index of cortical remyelination and clinical scores.
Even if childhood onset MS take longer to reach states of irreversible disability, severe disability will eventually occur at a young age. Moreover, pediatric MS could be responsible for cognitive disorders.
It is therefore of crucial relevance to develop research programs designed to generate novel imaging techniques to measure the efficacy of remyelinating therapies.
Finally, another extremely challenging issue in the care of children with MS is the difficulty of the transition between pediatric and adult care. Over last years, at the Pitié-Salpêtrière Hospital, the neurology team created a transition program called JUMP to improve medical, educational and psychosocial outcome for adolescent patients with MS .Taking part in the present study, young patients from 16 to 18 years old could have a direct access to the JUMP program, with the coordination of the dedicated nurses.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with MS | Experimental | Other: MRI without injection of contrast productChildren with MS |
| Volunteers | Experimental | Other: MRI without injection of contrast productmatched in age and sex with patients. Volunteers will perform only one brain MRI, as requested by the neurologist |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- age between 12 years old and 18 years old
- RR-MS defined by 2017 McDonald criteria
- no relapse the last 4 weeks
- no methylprednisolone or prednisolone the last 4 weeks.
- affiliated to the social security system
Key exclusion criteria (3 listed)
- Parental rejection
- Contre-indication of brain MRI: pace maker, tatoo of the face, claustrophobia….
- Pregnancy, copper intrauterine device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI without injection of contrast productMRI without injection of contrast product | Other | Patients with MS, Volunteers |
Primary outcome
MTR-based individual indices
Time frame: 1 day
To investigate the association between MTR-based individual indices of cortical myelin repair in children with MS and one cognitive score (Symbol Digital Modalities Test (SDMT)) at baseline
1 secondary outcome
indices of cortical remyelination
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Children With Multiple Sclerosis
Not yet recruitingPhase 2
A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
Relapsing-remitting Multiple Sclerosis
RecruitingPhase 2
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis
Active, not recruitingPhase 2
A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 3
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Active, not recruitingPhase 3
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI without injection of contrast product in people with Children With Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Maillart, MD, PH (1 42 16 19 75 ext. +33, elisabeth.maillart@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTR-based individual indices (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.