Characterizing Perceived Physical Fatigability in Nusinersen-treated SMA

StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 8 months later Dec 7, 2026 → Sep 6, 2027
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Record History

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  1. Primary completion pushed from Dec 7, 2026 to Sep 6, 2027
    • Study completion pushed from Feb 26, 2027 to Mar 26, 2028
    • Eligibility criteria expanded, about 5 words
  2. Eligibility criteria expanded, about 3 wordsv3
  3. Site contact updatedv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06955897
Lead Sponsor Columbia University
Collaborators: Biogen
Conditions
(from sponsor)		 Spinal Muscular Atrophy
Related terms Fatigue, Motor Activity, Muscular Atrophy, Spinal, Neuromuscular Diseases
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov