Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03087136
Other study ID # 61080516.4.1001.5336
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2017
Est. completion date March 31, 2025

Study information

Verified date January 2024
Source Pontificia Universidade Católica do Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria: 1. Parents / patient have an understanding, ability and willingness to fully comply with study procedures 2. Parents / patient have the ability to provide voluntary written, signed and dated informed consent to participate in the study 3. Be 6 months - 18 years of age at screening 4. Have clinical evidence of at least 1 attack suggestive of idiopathic inflammatory CNS disorder 5. 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. Exclusion Criteria: 1. 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 2. Current malignancy or history of malignancy in the past 5 years 3. Significant concurrent, uncontrolled medical condition that could affect subject's safety or impair the subject's participation in the study. 4. Current participation in any interventional trial. 5. Pregnant or breastfeeding

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
anti-aquaporin-4 antibody
Serum anti-aquaporin-4 antibody
anti-myelin oligodendrocyte glycoprotein
Serum anti-myelin oligodendrocyte glycoprotein

Locations

Country Name City State
Brazil Instituto de Neurologia de Curitiba Curitiba PR
Brazil Pontifical Catholic University of Rio Grande do Sul Porto Alegre RS
Brazil Santa Casa de Misericordia de Porto Alegre Porto Alegre RS
Brazil Hospital da Restauração de Recife Recife PE
Brazil Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto / Universidade de São Paulo Ribeirao Preto SP
Brazil Universidade Federal do Estado do Rio de Janeiro Rio de Janeiro RJ
Brazil Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Sao Paulo SP
Brazil Universidade Federal de Uberlândia Uberlandia MG

Sponsors (2)

Lead Sponsor Collaborator
Pontificia Universidade Católica do Rio Grande do Sul Teva Pharmaceuticals USA

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years
Secondary Clinical features • To compare the clinical and MRI features between pediatric MS patients with disease onset < 10 and > 10 years 2 years
Secondary epidemiology • To analyze the influence of latitude, ethnicity and past viral infections on the development of pediatric MS 2 years
Secondary autoantibodies • To determine the proportion of patients with pediatric MS and other inflammatory demyelinating CNS disorders with autoantibodies (anti-AQP4 and anti-MOG) 2 years
Secondary treatments • To identify the disease-modifying treatments used in pediatric MS cases by the treating physician and the occurrence of adverse events 2 years
See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT03269175 - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies Phase 4