Actively Recruiting

Phase Not Applicable
Age: 0Years - 16Years
All Genders
NCT06321965

Characterization of New Phenotypes of Patients With Spinal Muscular Atrophy Treated With SMN Restoring Therapy

Led by Hospices Civils de Lyon · Updated on 2026-01-30

60

Participants Needed

8

Research Sites

235 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

With the advent of new treatments for ASI, new phenotypes are emerging. The investigators propose to describe these new phenotypes by prospectively following children with ASI of all types treated with TRS and aged under 16 for 2 years. The investigators also propose to evaluate potential assessment tools to determine whether they are relevant for monitoring this population, either routinely or for future clinical trials. The investigators also aim to collect the total costs associated with ASI in order to propose a first prospective medico-economic study in France.

CONDITIONS

Official Title

Characterization of New Phenotypes of Patients With Spinal Muscular Atrophy Treated With SMN Restoring Therapy

Who Can Participate

Age: 0Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Genetically confirmed infantile or juvenile spinal muscular atrophy
  • Treated with a therapy that restores SMN protein expression (e.g. nusinersen, risdiplam, onasemnogene abeparvovec)
  • Aged 0 to 15 years inclusive
  • Informed consent signed by both parent(s)/legal guardian(s) and patient's assent
  • Affiliated or beneficiary of a health insurance plan (for inclusion in France)
Not Eligible

You will not qualify if you...

  • Other condition likely to interfere significantly with ASI assessment and clearly unrelated to the disease
  • Other associated neurological disease
  • Current pregnancy or breast-feeding (a pregnancy test will also be performed at inclusion)
  • Specific contraindication to MRI (metallic foreign body, claustrophobia, or other reasons) will exclude MRI but not study participation

AI-Screening

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Trial Site Locations

Total: 8 locations

1

Pediatric Rehabilitation Service - L'Escale Mother and Child Hospital

Bron, Rhone, France, 69500

Actively Recruiting

2

CHRU of Brest

Brest, France, 29609

Not Yet Recruiting

3

Pediatric Neurology and Resuscitation Raymond-Poincare Hospital

Garche, France, 92380

Not Yet Recruiting

4

Pediatric Neurology Swynghedauw Hospital

Lille, France, 59037

Not Yet Recruiting

5

Marseille University Hospital - Timone Hospital Department of Pediatric Neurology - Specialized Pediatrics and Child Medicine

Marseille, France, 13005

Not Yet Recruiting

6

I-Motion Pediatric Clinical Trial Platform Armand Trousseau Hospital

Paris, France, 75012

Not Yet Recruiting

7

Hautepierre Hospital - Mother and Child Hospital

Strasbourg, France, 67200

Not Yet Recruiting

8

Department of Pediatrics - Neurology and Infectious Diseases Toulouse University Hospital - Children's Hospital

Toulouse, France, 31059

Not Yet Recruiting

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Research Team

L

Laure LE GOFF, PI

CONTACT

T

Tiphanie GINHOUX

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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