GRASP-01-002NCT05257473
Defining Endpoints in Becker Muscular Dystrophy
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Record History
All 20 versions: 18 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗
Minor Trial completed Show 4 more changesShow less
- Final enrollment: 59 participants (planned 80)
- Eligibility criteria expanded, about 20 words
- Site details revised at 1 of 11 sites
- Publications: details revised at 1 of 1 entry
- Minor Primary and study completion pushed from Aug 2026 to Sep 30, 2026v19
- Minor Primary and study completion dates: May 2026 to Aug 2026v18
- Notable Primary completion date: May 2025 to May 2026
- Trial status: Recruiting to Active, Not Recruiting
- Site details revised at 11 of 11 sites
- Minor Site contacts updated at 2 of 11 sitesv15
Show 12 earlier versionsHide 12 earlier versions
- Minor Study sites revised (11)v14
- Minor Study sites revised (11)v13
- Minor Site contacts updated at 5 of 11 sitesv12
- Minor Site contacts updated at 1 of 11 sitesv11
- Notable Primary completion date: May 2024 to May 2025
- Study sites: 10 to 11
- Study completion date: Jan 2025 to May 2026
- Minor Site contacts updated at 1 of 10 sitesv9
- Notable Enrollment target: 150 to 80
- Eligibility criteria expanded, about 12 words
- Site contacts updated at 2 of 10 sites
- Minor Study sites: 9 to 10v7
- Minor Study sites: 1 to 9v5
- Minor Site contact updatedv4
- Notable Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Mar 2022 to Apr 13, 2022
- Site details revised
- Minor Primary completion date: Apr 2024 to May 2024
- Start date: Feb 2022 to Mar 2022
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
To assess the natural history of measures of muscle function in BMD
Timeframe: Through study completion, an average of 2 years
4-Stair Climb
Timeframe: Through study completion, an average of 2 years
100-Meter Timed Test
Timeframe: Through study completion, an average of 2 years
PERFORMANCE OF UPPER LIMB 2.0 (PUL)
Timeframe: Through study completion, an average of 2 years
HAND HELD DYNAMOMETRY (HHD) AND GRIP
Timeframe: Through study completion, an average of 2 years
TIMED UP-AND-GO (TUG)
Timeframe: Through study completion, an average of 2 years
Measures of Pulmonary Function (Seated and supine FVC)
Timeframe: Through study completion, an average of 2 years
Measures of Pulmonary Function (MEP and MIP)
Timeframe: Through study completion, an average of 2 years
Measures of Pulmonary Function (other)
Timeframe: Through study completion, an average of 2 years
Measure of ejection fraction (ECHO)
Timeframe: Through study completion, an average of 2 years
Measure of systolic and diastolic function (ECHO)
Timeframe: Through study completion, an average of 2 years
Sites
11 sites in 3 countries
United States 9, New Zealand 1, United Kingdom 1