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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other, Biological, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHRU of Brest
NOT_YET_RECRUITING
Brest
Pediatric Rehabilitation Service - L'Escale Mother and Child Hospital
RECRUITING
Bron
Pediatric Neurology and Resuscitation Raymond-Poincare Hospital
NOT_YET_RECRUITING
Garche
Pediatric Neurology Swynghedauw Hospital
NOT_YET_RECRUITING
Lille
Marseille University Hospital - Timone Hospital Department of Pediatric Neurology - Specialized Pediatrics and Child Medicine
NOT_YET_RECRUITING
Marseille
I-Motion Pediatric Clinical Trial Platform Armand Trousseau Hospital
NOT_YET_RECRUITING
Paris
Hautepierre Hospital - Mother and Child Hospital
NOT_YET_RECRUITING
Strasbourg
Department of Pediatrics - Neurology and Infectious Diseases Toulouse University Hospital - Children's Hospital
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Laure LE GOFF, PI
laure.le-goff@chu-lyon.fr
04.72.12.95.04
Backup
Tiphanie GINHOUX
Tiphanie.ginhoux01@chu-lyon.fr
04.27.85.77.23
Time Frame
Start Date: 2024-07-24
Estimated Completion Date: 2029-01-24
Participants
Target number of participants: 60
Treatments
Experimental: SMA patient treated with SRT
Patients aged 0-15 with SMA type 1, 2 or 3, treated with TRS (nusinersen/risdiplam/onasemnogene abeparvovec/other).
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov