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Metabolomics of Children With SMA

U

University Medical Centre Ljubljana

Status

Completed

Conditions

Spinal Muscular Atrophy

Treatments

Drug: Nusinersen

Study type

Observational

Funder types

Other

Identifiers

NCT04587492
0120-305/2018/11

Details and patient eligibility

About

The aim of the proposed project is to evaluate whether the metabolome of patients with spinal muscular atrophy (SMA) before the initiation of treatment with nusinersen differs from the metabolome of healthy individuals and whether it changes 14 months after treatment with nusinersen.

Full description

Spinal muscular atrophy (SMA) is a severe, debilitating disease and is an important source of morbidity and mortality of children. Novel disease modifying therapies can alter the natural course of the disease. However, many aspects of their action remain unknown. Metabolomics is the large-scale study of metabolites, within cells, biofluids, tissues or organisms. Collectively, these small molecules and their interactions within a biological system are known as the metabolome.

The aim of this study is to evaluate whether the metabolome of patients with SMA before the initiation of disease modifying therapy with nusinersen differs from the metabolome of healthy individuals. Next, we would like to asses whether tretament with nusinersen alters the metabolome of patients with SMA. Utilizing metabolomics, we would like to assess whether we can identify parameters reflecting the state of the disease in a particular patient, and parameters with diagnostic and/or prognostic value. Using metabolomics, we will aim to identify SMA patients that will positively respond to gene therapy.

Enrollment

35 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Genetically confirmed SMA
  • Age up to 21 years

Exclusion criteria

  • None

Trial design

35 participants in 1 patient group

Children with SMA
Description:
All children with SMA are eligible for the study
Treatment:
Drug: Nusinersen

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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