Phase 3 Study of Ataluren in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)
Trial · NCT01826487
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in 6MWD at Week 48 | Baseline, Week 48 | ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Multiple imputation was applied to impute missing values within the treatment groups. | meters | LEAST_SQUARES_MEAN |
| SECONDARY | Time to 10 Percent (%) Persistent Worsening in 6MWD | Baseline to Week 48 | ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Multiple imputation was applied to impute missing values within treatment groups. Here, 'Number analyzed 'signifies participants evaluable for specified categories. | days | MEDIAN |
| SECONDARY | Change From Baseline in Time to Walk/Run 10 Meters at Week 48 | Baseline, Week 48 | ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | seconds | MEAN |
| SECONDARY | Change From Baseline in Time to Climb 4 Stairs at Week 48 | Baseline, Week 48 | ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | seconds | MEAN |
| SECONDARY | Change From Baseline in Time to Descend 4 Stairs at Week 48 | Baseline, Week 48 | ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | seconds | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Physical Function Total Score as Measured by NSAA at Week 48 | Baseline, Week 48 | ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Change From Baseline in Activities of Daily Living and Disease Status at Week 48, as Assessed by a Standardized Survey Administered by Site Personnel | Baseline, Week 48 | ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Number analyzed 'signifies participants evaluable for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline in PODCI Transfers/Basic Mobility and Sports/Physical Functioning Scores at Week 48 | Baseline, Week 48 | ITT population included all participants who were randomized and received any study treatment; and had a valid baseline, and at least one valid post-baseline 6MWD value. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Ataluren Plasma Concentration | Weeks 8, 16, 24, 32, 40, and 48 | As-treated population included all randomized participants who actually received any study treatment. Here, 'Number analyzed 'signifies participants evaluable at specified timepoint. | mcg/mL | MEAN |
| OTHER_PRE_SPECIFIED | Study Drug Compliance | Baseline to Week 48 | As-treated population included all randomized participants who actually received any study treatment. | percentage of drug | MEAN |
| SECONDARY | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) | Baseline up to Week 54 | As-treated population included all randomized participants who actually received any study treatment. | percentage of 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01826487/outcomes