Trial · NCT01009294
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline up to Day 50 | All enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Complete Upper Limb Function Tasks as Measured by the Jebsen Test | Baseline and Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable upper limb function tasks data. | seconds | MEDIAN |
| SECONDARY | Upper Limb Function as Measured by the Brooke Upper Extremity Functional Rating Scale | Baseline and Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable upper limb function tasks data. | score on a scale | MEDIAN |
| SECONDARY | Participant Activities of Daily Living as Assessed Using the Egen Klassifikation (EK) Scale | Baseline and Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable EK Scale data. | score on a scale | MEDIAN |
| SECONDARY | Shoulder, Elbow, and Wrist Passive and Active Range of Motion as Measured by Goniometry | Baseline and Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable range of motion data. | degrees | MEDIAN |
| SECONDARY | Force Exerted During Elbow Flexion and Extension, Shoulder Abduction, Hand Grip, Key Grip, and Finger Pinch as Assessed by Upper Extremity Myometry | Baseline and Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable upper extremity myometry data. | Newton | MEDIAN |
| SECONDARY | Time to Complete Hand Fine Motor Coordination and Dexterity Tasks as Measured by 9-Hole Peg Test (9HPT) | Baseline and Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable 9HPT data. | seconds | MEDIAN |
| SECONDARY | Forced Vital Capacity (FVC) as Measured by Spirometry | Baseline and Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable spirometry data. Data was not collected at Week 6 as no participants were evaluable at this timepoint. | liters | MEDIAN |
| SECONDARY | Systolic and Diastolic Function as Measured by Echocardiography With Tissue Doppler | Week 24 and Week 48 | All enrolled participants who received at least 1 dose of study drug and with evaluable echocardiography data. Since the study was terminated early, echocardiography data were not collected after the start of study drug administration. | ||
| SECONDARY | Heart Rate as Assessed by Radial Pulse | Baseline and Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable heart rate data. | beats per minute | MEDIAN |
| SECONDARY | Verbal Memory and Attention as Assessed by the Digit Span Task | Baseline and Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable verbal memory and attention data. The test was repeated until the participant had 0 correct responses, which was up to 7 times for the Forward Condition and up to 5 times for the Backward Condition at Baseline and at Week 6. | correct responses | NUMBER |
| SECONDARY | HRQL as Measured by the PedsQL Inventory Generic Core Scale | Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable PedsQL Inventory Generic Core Scale data at Week 6. | units on a scale | MEDIAN |
| SECONDARY | HRQL as Measured by the PedsQL Multidimensional Fatigue Scale | Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable PedsQL Multidimensional Fatigue Scale data at Week 6. | units on a scale | MEDIAN |
| SECONDARY | HRQL as Measured by the INQoL | Week 24 and Week 48 | All enrolled participants who received at least 1 dose of study drug and with evaluable INQoL data. Since the study was terminated early, INQoL data were not collected. | ||
| SECONDARY | Muscle Fragility as Determined by Serum Creatine Kinase (CK) Levels | Baseline and Week 6 | All enrolled participants who received at least 1 dose of study drug and with evaluable CK data. Data was not collected at Week 6 for CK Levels with the reference range of 18-363 UL as no participants were evaluable at this timepoint. | units/liter (U/L) | MEDIAN |
| SECONDARY | Gastrocnemius Muscle Dystrophin Expression as Determined by Immunofluoresence or by Western Blotting Techniques | Week 36 | All enrolled participants who received at least 1 dose of study drug and with evaluable dystrophin production data. Since the study was terminated early, gastrocnemius muscle dystrophin expression data were not collected after the start of study drug administration. | ||
| SECONDARY | Study Drug Compliance | Baseline to Day 50 | All enrolled participants who received at least 1 dose of study drug and with evaluable study drug compliance data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics: Ataluren Plasma Exposure | 0, 2, 3, 6, 8, 9, 12, 14, 15, and 24 hours after the morning dose | All enrolled participants who received at least 1 dose of study drug and with evaluable plasma data. Since the study was terminated early, steady state data were not collected at Week 6. |
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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GET https://conductscience.org/api/trials/v1/NCT01009294/outcomes