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SMOBNCT04690998

Outcome Measures and Biomarkers in a Cohort of Spinal Muscular Atrophy Type III/ IV Patients

StatusCompleted
PhaseNot applicable
Primary completion
Track this trial

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Record History

All 9 versions: 7 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Unknown → Completed Show 4 more changesShow less
    • Study completion date changed from estimate of Oct 8, 2025 to Dec 3, 2025
    • Eligibility criteria expanded, about 8 words
    • Study description expanded, about 9 words
    • Site details revised at 2 of 11 sites
  2. Changed Registry marked status Unknown; last known: Active, Not Recruiting
  3. Trial status: Recruiting to Unknownv8 Show 4 more changesShow less
    • Enrollment target: estimated 100 to confirmed 104
    • Primary completion date changed from estimate of Jul 13, 2023 to Oct 8, 2023
    • Study completion date: Jul 13, 2025 to Oct 8, 2025
    • Site details revised at 11 of 11 sites
  4. Primary completion date: Jul 13, 2025 to Jul 13, 2023v6
  5. Primary and study completion dates: Dec 2024 to Jul 13, 2025v5
Show 2 earlier versionsHide 2 earlier versions
  1. Site details revised at 9 of 11 sitesv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2021 to Jul 13, 2021
    • Study sites: 0 to 11
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Clinical examination
Timeframe: Change from Baseline at 6 months, 12 months, 18 months, 24 months
VAS
Timeframe: Change from Baseline at 6 months, 12 months, 18 months, 24 months
Fatigue Severity Scale (FSS)
Timeframe: Change from Baseline at 6 months, 12 months, 18 months, 24 months
Muscle strength
Timeframe: Change from Baseline at 6 months, 12 months, 18 months, 24 months
Timed test
Timeframe: Change from Baseline at 6 months, 12 months, 18 months, 24 months
Pulmonary function test
Timeframe: Change from Baseline at 12 months and 24 months
Quality of Life of patients
Timeframe: Change from Baseline at 6 months, 12 months, 18 months, 24 months
Blood samples
Timeframe: Change from Baseline at 12 months and 24 months
MRI
Timeframe: Change from Baseline at 24 months

Arms and interventions

Without treatment for SMAOther

Patient that will not take treatment for SMA during the two years of the study.

Under treatment for SMAOther

Patient that will take treatment for SMA during the two years of the study

Other: Blood Samples, MRI

Sites

11 sites in 1 country