European Registry of Patients With Infantile-onset Spinal Muscular Atrophy

NCT ID: NCT03339830

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-10

Study Completion Date

2020-11-15

Brief Summary

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IO-SMA-Registry is a prospective, longitudinal and observational study which objective is to collect prospectively information on longevity, psychomotor development and respiratory function of patients with infantile-onset spinal muscular atrophy.

Detailed Description

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Conditions

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Spinal Muscular Atrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Spinal Muscular Atrophy diagnosed in childhood (before 18 months) and genetically confirmed.
* For patients with SMA type 1: Never acquired independent sitting position (more than 30 seconds, without hand support or any external support)
* For patients with SMA type 2 or 3: Patient treated with a market approved treatment for SMA or with a treatment in an expanded access program
* Any age
* Patients over 18 years of age or parent(s)/legal guardian(s) of patients \< 18 years of age not opposed to data collection for research purposes

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Myologie, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Servais, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Myology

Locations

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Hopital Morvan - CHU de Brest

Brest, , France

Site Status

Service de Rééducation Pédiatrique Infantile " L'Escale " - Hôpital Femme Mère Enfant

Bron, , France

Site Status

Hôpital le Bocage - CHU Dijon

Dijon, , France

Site Status

Maladie Neuromusculaire de l'enfant - Service Maladies infectieuses et neurologie infantile - Hôpital Roger Salengro

Lille, , France

Site Status

I-Motion Institute

Paris, , France

Site Status

Unité de neurologie pédiatrique - Hôpital des enfants

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2017-A02291-52

Identifier Type: OTHER

Identifier Source: secondary_id

IO-SMA-Registry

Identifier Type: -

Identifier Source: org_study_id

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