Actively Recruiting

Age: 12Years +
All Genders
NCT06955897

Characterizing Perceived Physical Fatigability in Nusinersen-treated SMA

Led by Columbia University · Updated on 2026-05-14

45

Participants Needed

1

Research Sites

96 weeks

Total Duration

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Sponsors

C

Columbia University

Lead Sponsor

B

Biogen

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this project is to investigate the utility of the SMA EFFORT, an SMA-specific patient-reported outcome measure, to assess perceived physical fatigability that is anchored to intensity and duration of activities. We aim to characterize perceived physical fatigability (PPF) in a diverse cohort of people with SMA (pwSMA) and evaluate the change of PPF before and after nusinersen dosing.

CONDITIONS

Official Title

Characterizing Perceived Physical Fatigability in Nusinersen-treated SMA

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All types of 5qSMA with homozygous deletion or point mutation of the SMN1 gene and any number of SMN2 copies
  • Receiving a stable dosing regimen of 12 or 28 mg nusinersen for at least 6 months
Not Eligible

You will not qualify if you...

  • Injury or surgery within the previous 3 months affecting ability to perform function or fatigability assessments
  • Enrolled in an ongoing clinical trial, extension study, expanded access program, or long-term registry of investigational or recently approved medication
  • Receiving adjuvant and/or dual therapy such as muscle-targeted, NMJ, or symptomatic treatments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

R

Rafael Rodriguez-Torres, DPT

CONTACT

C

Cara Kanner, DPT

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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