Trial · NCT02193074
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Motor Milestones Responders | assessed at the later of the Day 183, Day 302, or Day 394 study visits | Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.) | percentage of participants | NUMBER |
| PRIMARY | Time to Death or Permanent Ventilation | Day 91, Day 182, Day 273, Day 364, Day 394 | Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and who died or required permanent ventilation. | proportion of participants | NUMBER |
| SECONDARY | Percentage of Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) Responders | assessed at Baseline and the later of the Day 183, Day 302, or Day 394 study visits | Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.) | percentage of participants | NUMBER |
| SECONDARY | Summary of Time to Death | Day 91, Day 182, Day 273, Day 364, Day 394 | Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and who died. Results are based on all available data. | proportion of particiants | NUMBER |
| SECONDARY | Percentage of Participants Not Requiring Permanent Ventilation | Up to Day 394 | Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Compound Muscular Action Potential (CMAP) Responders | assessed at the later of the Day 183, Day 302, or Day 394 study visits | Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.) | percentage of participants | NUMBER |
| SECONDARY | Time to Death or Permanent Ventilation in the Subgroup of Participants Below the Study Median Disease Duration | Day 91, Day 182, Day 273, Day 364, Day 394 | Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and were below the study median disease duration. | proportion of participants | NUMBER |
| SECONDARY | Time to Death or Permanent Ventilation in the Subgroup of Participants Above the Study Median Disease Duration | Day 91, Day 182, Day 273, Day 364, Day 394 | Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and were above the study median disease duration. | proportion of participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Adverse Events (AEs), Serious AEs (SAEs) and Discontinuations Due to AEs | Screening through Day 394 (± 7 days) or early termination | Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure. | participants | NUMBER |
| SECONDARY | Number of Participants With AEs Corresponding to Changes in Hematology Values | up to Day 394 (± 7 days) or early termination | Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure. | participants | NUMBER |
| SECONDARY | Number of Participants With AEs Corresponding to Changes in Blood Chemistry Values | up to Day 394 (± 7 days) or early termination | Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure. | participants | NUMBER |
| SECONDARY | Number of Participants Meeting Selected Vital Sign Criteria Post-Baseline | up to Day 394 (± 7 days) or early termination | Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure and had an assessment. | participants | NUMBER |
| SECONDARY | Summary of Shifts in 12-lead Electrocardiogram (ECG) Results | up to Day 394 (± 7 days) or early termination | Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure and whose baseline value was not abnormal and who had at least one post-baseline value. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Changes From Baseline in Urinalysis Values | up to Day 394 (± 7 days) or early termination | Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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