Trial · NCT03179631
Outcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
21 to 39 of 39
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | DB Period: Time to Loss of Stair-Climbing - mITT Population | Baseline up to approximately Week 72 (Due to COVID, many participants attended the protocol-defined Week 72 visit late) | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. Here, 'Overall number of participants analyzed' = participants with loss of stair-climbing by Week 72. | weeks | MEDIAN |
| SECONDARY | DB Period: Time to Loss of Stair-Climbing - ITT Population | Baseline up to approximately Week 72 (Due to COVID, many participants attended the protocol-defined Week 72 visit late) | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. Here, 'Overall number of participants analyzed' = participants with loss of stair-climbing by Week 72. | weeks | MEDIAN |
| SECONDARY | DB Period: Time to Loss of Stair-Descending - mITT Population | Baseline up to approximately Week 72 (Due to COVID, many participants attended the protocol-defined Week 72 visit late) | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. Here, 'Overall number of participants analyzed' = participants with loss of stair-descending by Week 72. | weeks | MEDIAN |
| SECONDARY | DB Period: Time to Loss of Stair-Descending - ITT Population | Baseline up to approximately Week 72 (Due to COVID, many participants attended the protocol-defined Week 72 visit late) | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. Here, 'Overall number of participants analyzed' = participants with loss of stair-descending by Week 72. | weeks | MEDIAN |
| SECONDARY | DB Period: Number of Participants With Function Loss of NSAA Items at Week 72 - mITT Population | Week 72 | The mITT population included all randomized participants who met the following additional criteria: 7 to 16 years old with 6MWD ≥300 meters and time to stand from supine ≥5 seconds at baseline. Here, 'Number analyzed' = number of participants with baseline score of 2 or 1 of NSAA items and at least one post-baseline assessment for the specific activity. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DB Period: Number of Participants With Function Loss of NSAA Items at Week 72 - ITT Population | Week 72 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. Here, 'Number analyzed' = number of participants with baseline score of 2 or 1 and at least one post-baseline assessment for the specific activity of NSAA items. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline up to Week 76 | The as-treated population included all randomized participants who received study treatment, with treatment assignments designated according to actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Treatment Period: Change From Baseline in 6MWD at Week 144 | Baseline, Week 144 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | meters | LEAST_SQUARES_MEAN |
| SECONDARY | Overall Treatment Period: Composite of Average Change From Baseline in TFTs at Week 144 | Baseline, Week 144 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Overall Treatment Period: Change From Baseline in Time to Run/Walk 10 Meters at Week 144 | Baseline, Week 144 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Overall Treatment Period: Change From Baseline in Time to Climb 4 Stairs at Week 144 | Baseline, Week 144 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Overall Treatment Period: Change From Baseline in Time to Descend 4 Stairs at Week 144 | Baseline, Week 144 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Overall Treatment Period: Change From Baseline in NSAA Total Score at Week 144 | Baseline, Week 144 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Overall Treatment Period: Time to Loss of Ambulation Over 144 Weeks | Baseline up to Week 144 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. Here, 'Overall number of participants analyzed' = participants with loss of ambulation by Week 144. | weeks | MEDIAN |
| SECONDARY | Overall Treatment Period: Time to Loss of Stair-Climbing Over 144 Weeks | Baseline up to Week 144 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. Here, 'Overall number of participants analyzed' = participants with loss of stair-climbing by Week 144. | weeks | MEDIAN |
| SECONDARY | Overall Treatment Period: Time to Loss of Stair- Descending Over 144 Weeks | Baseline up to Week 144 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. Here, 'Overall number of participants analyzed' = participants with loss of stair-descending by Week 144. | weeks | MEDIAN |
| SECONDARY | Overall Treatment Period: Number of Participants With Function Loss of NSAA Items at Week 144 | Week 144 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. Here, 'Number analyzed' = number of participants with baseline score of 2 or 1 and at least one post-baseline assessment for the specific activity in NSAA items. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Treatment Period: Number of Participants With TEAEs | Baseline up to Week 148 | The as-treated-OA population included all randomized participants who received at least 1 dose of ataluren anytime during the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | OL Period: Plasma Pharmacokinetic (PK) Concentration of Ataluren | Predose and 2 hours postdose at Week 144 | The ITT population included all participants who were randomized, with treatment assignments designated according to initial randomization, regardless of whether participants received a different study treatment from the one randomized. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | micrograms (µg)/milliliter (mL) | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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