Multiple SclerosisEMOCEMPNCT03087136
A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil
An observational study of Multiple Sclerosis, run by Pontificia Universidade Católica do Rio Grande do Sul at 8 sites in Brazil.
Trial summary
Pediatric Multiple sclerosis (MS) is a chronic inflammatory disease defined by multiple episodes of demyelination of the central nervous system (CNS) separated by time and space as specified in adults not explained by acute disseminated encephalomyelitis (ADEM). Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- anti-aquaporin-4 antibody and anti-myelin oligodendrocyte glycoprotein
- How many people
- 100 participants
- Where
- 8 sitesBrazil
- Study dates
- 1 Mar 2017to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: In this observational study, we will select 8 MS centers in Brazil to recruit at least 100 pediatric patients currently followed on each center with idiopathic inflammatory CNS disorders over a 2-year study period. We will collect retrospective and prospective clinical and MRI data to determine the proportion of patients who fulfill the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for MS, especially on those below 10 years where the use of McDonald 2010 criteria is not recommended routinely. Following the inclusion on the study, subjects will be followed for at least 2 years.
Who may be able to join
- Parents / patient have an understanding, ability and willingness to fully comply with study procedures
- Parents / patient have the ability to provide voluntary written, signed and dated informed consent to participate in the study
- Be 6 months - 18 years of age at screening
- Have clinical evidence of at least 1 attack suggestive of idiopathic inflammatory CNS disorder
- Have at least one brain MRI with available images (for review)
- For the exploratory MRI study, parents / patients have to agree to perform 2 MRI scans (at baseline and at the end of the study). Considering the age of the study subjects, sedation may be required during the acquisition of the MRI.
Who cannot join
- Current evidence or known history of clinically significant infection including:
- Chronic or ongoing active infectious disease requiring long-term systemic treatment such as active hepatitis B or C, HIV or tuberculosis
- Current malignancy or history of malignancy in the past 5 years
- Significant concurrent, uncontrolled medical condition that could affect subject's safety or impair the subject's participation in the study.
- Current participation in any interventional trial.
- Pregnant or breastfeeding
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Instituto de Neurologia de Curitiba
Curitiba, Paraná, 81210310
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020090
Pontifical Catholic University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 9061000
Hospital da Restauração de Recife
Recife, Pernambuco, 50110900
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto / Universidade de São Paulo
Ribeirão Preto, São Paulo, 65470000
Universidade Federal do Estado do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 22290255
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403010
Universidade Federal de Uberlândia
Uberlândia, Minas Gerais, 38405320
About this study
Pediatric Multiple sclerosis (MS) is a chronic inflammatory disease defined by multiple episodes of demyelination of the central nervous system (CNS) separated by time and space as specified in adults not explained by acute disseminated encephalomyelitis (ADEM). Several studies have indicated that at least 5% of MS patients are in the pediatric population, but no prospective study was performed in Brazil. There are particular characteristics of Pediatric MS that differs from the adult population and have been focus of interest in the last years. However, we still lack high evidence data, specially concerning treatment, of this age group.
This is an observational non-interventional multicenter study in pediatric MS patients in which participating subjects will be characterized by their clinical, MRI and immunological features. In this observational study, we will select 8 MS centers in Brazil to recruit at least 100 pediatric patients currently followed on each center with idiopathic inflammatory CNS disorders over a 2-year study period. We will collect retrospective and prospective clinical and MRI data to determine the proportion of patients who fulfill the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for MS,7 especially on those below 10 years where the use of McDonald 2010 criteria is not recommended routinely. Following the inclusion on the study, subjects will be followed for at least 2 years.
Read more
All subjects enrolled in this study will have serum collected to test autoantibodies including anti-AQP4 and anti-MOG using cell-based assays with transfected cells.8 Pediatric patients with positive testing for these autoantibodies will be analyzed separately.
Exploratory MRI sub-study In 10 patients recruited at Hospital São Lucas PUCRS, we will perform an exploratory substudy with advanced MRI using q-space diffusion protocol on a 3-Tesla MRI (GE Signa HDx 3.0T, General Electric, Milwaukee, WI, USA) and a 8-channel head coil to visualize remyelinating brain MS lesions. Normalized leptokurtic diffusion (NLD) data will be acquired using diffusion-weighted echo planar imaging. All MRI scans from this exploratory study will be performed at the Brain Institute of Rio Grande do Sul (BraIns). Only patients with previous brain demyelinating lesions will be included in this exploratory sub-study.
- Conditions
- Multiple Sclerosis
- Being tested
- anti-aquaporin-4 antibody, anti-myelin oligodendrocyte glycoprotein
- Keywords
- multiple sclerosis, pediatric
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-aquaporin-4 antibodyDiagnostic test
Serum anti-aquaporin-4 antibody
anti-myelin oligodendrocyte glycoproteinDiagnostic test
Also called (anti-MOG)
Serum anti-myelin oligodendrocyte glycoprotein
What is being measured
The primary outcome is the main question the study is designed to answer.
Convertion rate to MS
To evaluate the proportion of patients (below and above 10 years-old) with idiopathic inflammatory CNS disorders converting to pediatric MS in Brazilian MS referral centers.
Measured: 2 years
Secondary outcomes (4)
Clinical features
- To compare the clinical and MRI features between pediatric MS patients with disease onset < 10 and > 10 years
Measured: 2 years
epidemiology
- To analyze the influence of latitude, ethnicity and past viral infections on the development of pediatric MS
Measured: 2 years
autoantibodies
- To determine the proportion of patients with pediatric MS and other inflammatory demyelinating CNS disorders with autoantibodies (anti-AQP4 and anti-MOG)
Measured: 2 years
treatments
- To identify the disease-modifying treatments used in pediatric MS cases by the treating physician and the occurrence of adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Mar 2017
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
- Investigators
- Douglas K Sato, Principal investigator, Pontifical Catholic University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087136
- Sponsor's protocol ID
- 61080516.4.1001.5336
- Acronym
- EMOCEMP
- Status last verified
- Jan 2024
- First submitted
- 15 Mar 2017
- Last updated
- 8 Jan 2024
- 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 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil
- ClinicalTrials.gov ID
- NCT03087136
- Acronym / sponsor ID
- EMOCEMP / 61080516.4.1001.5336
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, pediatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 22 Mar 2017 (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.
Pediatric Multiple sclerosis (MS) is a chronic inflammatory disease defined by multiple episodes of demyelination of the central nervous system (CNS) separated by time and space as specified in adults not explained by acute disseminated encephalomyelitis (ADEM). Several studies have indicated that at least 5% of MS patients are in the pediatric population, but no prospective study was performed in Brazil. There are particular characteristics of Pediatric MS that differs from the adult population and have been focus of interest in the last years. However, we still lack high evidence data, specially concerning treatment, of this age group.
This is an observational non-interventional multicenter study in pediatric MS patients in which participating subjects will be characterized by their clinical, MRI and immunological features. In this observational study, we will select 8 MS centers in Brazil to recruit at least 100 pediatric patients currently followed on each center with idiopathic inflammatory CNS disorders over a 2-year study period. We will collect retrospective and prospective clinical and MRI data to determine the proportion of patients who fulfill the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for MS,7 especially on those below 10 years where the use of McDonald 2010 criteria is not recommended routinely. Following the inclusion on the study, subjects will be followed for at least 2 years.
All subjects enrolled in this study will have serum collected to test autoantibodies including anti-AQP4 and anti-MOG using cell-based assays with transfected cells.8 Pediatric patients with positive testing for these autoantibodies will be analyzed separately.
Exploratory MRI sub-study In 10 patients recruited at Hospital São Lucas PUCRS, we will perform an exploratory substudy with advanced MRI using q-space diffusion protocol on a 3-Tesla MRI (GE Signa HDx 3.0T, General Electric, Milwaukee, WI, USA) and a 8-channel head coil to visualize remyelinating brain MS lesions. Normalized leptokurtic diffusion (NLD) data will be acquired using diffusion-weighted echo planar imaging. All MRI scans from this exploratory study will be performed at the Brain Institute of Rio Grande do Sul (BraIns). Only patients with previous brain demyelinating lesions will be included in this exploratory sub-study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- In this observational study, we will select 8 MS centers in Brazil to recruit at least 100 pediatric patients currently followed on each center with idiopathic inflammatory CNS disorders over a 2-year study period. We will collect retrospective and prospective clinical and MRI data to determine the proportion of patients who fulfill the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for MS, especially on those below 10 years where the use of McDonald 2010 criteria is not recommended routinely. Following the inclusion on the study, subjects will be followed for at least 2 years.
Key inclusion criteria (6 listed)
- Parents / patient have an understanding, ability and willingness to fully comply with study procedures
- Parents / patient have the ability to provide voluntary written, signed and dated informed consent to participate in the study
- Be 6 months - 18 years of age at screening
- Have clinical evidence of at least 1 attack suggestive of idiopathic inflammatory CNS disorder
- Have at least one brain MRI with available images (for review)
Key exclusion criteria (6 listed)
- Current evidence or known history of clinically significant infection including:
- Current malignancy or history of malignancy in the past 5 years
- Significant concurrent, uncontrolled medical condition that could affect subject's safety or impair the subject's participation in the study.
- Current participation in any interventional trial.
- Pregnant or breastfeeding
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 |
|---|---|---|
| anti-aquaporin-4 antibodySerum anti-aquaporin-4 antibody | Diagnostic test | – |
| anti-myelin oligodendrocyte glycoproteinAlso: (anti-MOG)Serum anti-myelin oligodendrocyte glycoprotein | Diagnostic test | – |
Primary outcome
Convertion rate to MS
Time frame: 2 years
To evaluate the proportion of patients (below and above 10 years-old) with idiopathic inflammatory CNS disorders converting to pediatric MS in Brazilian MS referral centers.
4 secondary outcomes
Clinical features
Time frame: 2 years
epidemiology
Time frame: 2 years
autoantibodies
Time frame: 2 years
treatments
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Douglas K Sato principal investigator
Pontifical Catholic University of Rio Grande do Sul
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Pontificia Universidade Católica do Rio Grande do Sul at 8 sites in Brazil.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Convertion rate to MS (time frame: 2 years). 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 8 Jan 2024.