NCT05866939

Brief Summary

The goal of this observational study is to to establish profiles of clinical progression in patients affected by the different types of SMA (type I, II and III) treated with the currently approved drugs using a structured battery of clinical tests. Another goal of the study is to assess the progression of the disease in patients identified through neonatal screening.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 19, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

April 18, 2023

Last Update Submit

May 10, 2023

Conditions

Keywords

spinal muscular atrophy

Outcome Measures

Primary Outcomes (3)

  • Establish profiles of clinical progression in patients affected by the different types of SMA (type I, II and III) treated with the currently approved drugs using a structured battery of clinical tests.

    2-year

  • Assess the progression of the disease in patients identified through neonatal screening

    2-year

  • Identification of molecular biomarkers that associate with disease course and response to therapies

    2-year

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with spinal muscular atrophy regardless of age, type of SMA or treatment

You may qualify if:

  • All SMA patients

You may not qualify if:

  • Inability to understand or to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesNeuromuscular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 19, 2023

Study Start

June 30, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2025

Last Updated

May 19, 2023

Record last verified: 2023-04