Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 19 of 19

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Baseline up to Week 89	All enrolled participants who received at least 1 dose of study drug (As-Treated Population).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in 6-Minute Walk Distance (6MWD) as Measured by the 6-minute Walk Test (6MWT)	Baseline, Week 48 and Week 60	All enrolled participants who received at least 1 dose of study drug, were ambulatory, and had evaluable 6MWT data. Participants who were ambulatory were able to walk ≥75 meters unassisted at screening.	meters	MEAN
SECONDARY	Change From Baseline in Proximal Muscle Function as Assessed by Speed During Timed Function Tests	Baseline, Week 48 and Week 60	All enrolled participants who received at least 1 dose of study drug, were ambulatory, and had evaluable data for the applicable timed function test. Participants who were ambulatory were able to walk ≥75 meters unassisted at screening.	seconds	MEAN
SECONDARY	Change From Baseline in Standing From Supine Position as Assessed by Method Scores During Timed Function Tests	Baseline, Week 48 and Week 60	All enrolled participants who received at least 1 dose of study drug, were ambulatory, and had evaluable method data for standing from supine. Participants who were ambulatory were able to walk ≥75 meters unassisted at screening.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Run/Walk 10-Meters as Assessed by Method Scores During Timed Function Tests	Baseline, Week 48 and Week 60	All enrolled participants who received at least 1 dose of study drug, were ambulatory, and had evaluable method data for running/walking 10 meters. Participants who were ambulatory were able to walk ≥75 meters unassisted at screening.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Ascending 4 Stairs as Assessed by Method Scores During Timed Function Tests	Baseline, Week 48 and Week 60	All enrolled participants who received at least 1 dose of study drug, were ambulatory, and had evaluable method data for ascending 4 stairs. Participants who were ambulatory were able to walk ≥75 meters unassisted at screening.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Descending 4 Stairs as Assessed by Method Scores During Timed Function Tests	Baseline, Week 48 and Week 60	All enrolled participants who received at least 1 dose of study drug, were ambulatory, and had evaluable method data for descending 4 stairs. Participants who were ambulatory were able to walk ≥75 meters unassisted at screening.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Force Exerted During Knee Flexion and Extension, Elbow Flexion and Extension, Shoulder Abduction, and Hand Grip as Assessed by Myometry	Baseline, Week (Wk) 48 and Wk 60	All enrolled participants who received at least 1 dose of study drug and had Baseline and on-treatment data (Evaluable Population) with evaluable myometry data.	pounds	MEAN
SECONDARY	Change in Resting, Active, and Recovery Heart Rate as Assessed by Heart Rate Monitoring With the Polar RS400	Baseline, Week 48 and Week 60	All enrolled participants who received at least 1 dose of study drug, were ambulatory, and had evaluable heart rate data. Participants who were ambulatory were able to walk ≥75 meters unassisted at screening.	beeps per minute	MEAN
SECONDARY	Change From Baseline in Verbal Memory and Attention as Assessed by the Digit Span Task	Baseline, Week 48 and Week 60	All enrolled participants who received at least 1 dose of study drug and had Baseline and on-treatment data (Evaluable Population) with evaluable verbal memory and attention data.	digits recalled	MEAN
SECONDARY	Change From Baseline in Participant-Reported Health-Related Quality of Life (HRQL) as Measured by the Pediatric Quality of Life Inventory (PedsQL) Inventory	Baseline, Week 48 and Week 60	All enrolled participants who received at least 1 dose of study drug and had Baseline and on-treatment data (Evaluable Population) with evaluable participant-reported PedsQL data.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Parent- or Caregiver-Reported HRQL as Measured by the PedsQL Inventory	Baseline, Week 48 and Week 60	All enrolled participants who received at least 1 dose of study drug and had Baseline and on-treatment data (Evaluable Population) with evaluable parent- or caregiver-reported PedsQL data.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Serum Creatine Kinase (CK) Levels	Baseline, Week 48 and Week 60	All enrolled participants who received at least 1 dose of study drug and had Baseline and on-treatment data (Evaluable Population) with evaluable CK data.	U/L	MEAN
SECONDARY	Change From Baseline in Dystrophin Expression on Biceps Muscle Biopsy as Measured by Immunofluorescence Staining of the Sarcolemmal Membrane With an Antibody to the C-Terminal Portion of the Dystrophin Protein	Baseline, Week 24	All enrolled participants who received at least 1 dose of study drug (As-Treated Population) and had evaluable dystrophin expression data.	dystrophin positive fibers	MEAN
SECONDARY	Study Drug Compliance	Baseline up to Week 89	All enrolled participants who received at least 1 dose of study drug (As-Treated Population).	percentage of doses of study drug	MEDIAN
SECONDARY	Pharmacokinetics: Ataluren Plasma Exposure in All Participants	0 (pre-dose), 0.5, 1, 2, 3, and 4 hours post-morning dose and 0 (pre-dose) and 2 hours post-midday dose on Day 2 of Week 1 and Day 2 of Week 6	All enrolled participants who received at least 1 dose of study drug (As-Treated Population) and had evaluable plasma data.	μg/mL	MEAN
SECONDARY	Pharmacokinetics: Ataluren Plasma Exposure in Ambulatory Participants	0 (pre-dose), 0.5, 1, 2, 3, and 4 hours post-morning dose and 0 (pre-dose) and 2 hours post-midday dose on Day 2 of Week 1 and Day 2 of Week 6	All enrolled participants who received at least 1 dose of study drug, were ambulatory, and had evaluable plasma data. Participants who were ambulatory were able to walk ≥75 meters unassisted at screening.	μg/mL	MEAN
SECONDARY	Corticosteroid Plasma Concentrations as Assessed by a Validated Bioanalytical Method, in Participants Who Received a Daily Corticosteroid Regimen With Prednisone or Deflazacort	0 (pre-dose), 0.5, 1, 2, 3, and 4 hours post-morning dose and 0 (pre-dose) and 2 hours post-midday dose on Day 2 of Week 1 and Day 2 of Week 6	All enrolled participants who received at least 1 dose of study drug (As-Treated Population) and had evaluable prednisone or deflazacort plasma data.	ng/mL	MEAN
SECONDARY	Change in Muscle Composition as Assessed by Limb Magnetic Resonance (MR) Testing	Baseline, Week 48, Week 60	All enrolled participants who received at least 1 dose of study drug and had Baseline and on-treatment data (Evaluable Population) with evaluable muscle composition data. Muscle composition data were not collected or analyzed for this extension study.

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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