Trial · NCT01603407
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Forced Vital Capacity | Average of Months 3, 6, 12, 18, 24, 30 and 36 visits | Forced vital capacity was measured during a spirometry test. Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. |
| Primary | Rise From the Floor Velocity | Average of Months 3, 6, 12, 18, 24, 30 and 36 visits | Reciprocal of time to rise from the floor |
| Primary | Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction With Treatment Score | Average of Months 3, 6, 12, 18, 24, 30 and 36 visits | The TSQM Global Satisfaction with Treatment is a 14-item questionnaire that ranges from 0 - 100 with higher scores indicating better outcomes. |
| Secondary | North Star Ambulatory Assessment (NSAA) Score | Average of Months 3, 6, 12, 18, 24, 30 and 36 visits | The North Star Ambulatory Assessment (NSAA) is a 17-item rating scale that is used to measure functional motor abilities in ambulant children with Duchenne Muscular Dystrophy (DMD). It is usually used to monitor the progression of the disease and treatment effects. The activities are graded as follows: 2 - "Normal" - no obvious modification of activity 1 - Modified method but achieves goal independent of physical assistance from another 0 - Unable to achieve independently This scale is ordinal with 34 as the maximum score indicating fully-independent function. |
| Secondary | 6 Minute Walk Test | Average of Months 3, 6, 12, 18, 24, 30 and 36 visits | Measures the total distance walked in 6 minutes averaged over all post-baseline follow-up visits through Month 36. |
| Secondary | Range of Motion (Goniometry) of Left Ankle | Average of Months 3, 6, 12, 18, 24, 30 and 36 visits | Range of motion at the ankle joint in dorsiflexion measured in degrees from plantigrade averaged over all post-baseline visits. |
| Secondary | Range of Motion (Goniometry) of Right Ankle | Average of Months 3, 6, 12, 18, 24, 30 and 36 visits | Range of motion at the ankle joint in dorsiflexion measured in degrees from plantigrade averaged over all post-baseline visits. |
| Secondary | Number of Participants Who Tolerated the Regimen | 3 years | The number of participants who completed 36 months of follow-up on the originally assigned dosage (for weight) of study medication. |
| Secondary | Heart Rate | 36 months | Measured by trans-thoracic echocardiogram and 12-lead ECG. |
| Secondary | Quality of Life - Parent | Average of Months 12, 24, and 36 visits | Quality of life was measured by parent/guardian self-report for all children utilizing the PEDSQL measurement tool. This is a 23-question tool. Scores can range from 0 to 100, with higher scores indicating better quality of life for the child. |
| Secondary | Quality of Life- Child | Average of Months 12, 24, and 36 visits | Quality of life was measured by child self-report in children age 5 and older utilizing the PEDSQL measurement tool. This is a 23-question tool. Scores can range from 0 to 100, with higher scores indicating better quality of life. |
| Secondary | Left Ventricular Ejection Fraction Percent | 36 months | Measured by trans-thoracic echocardiogram and 12-lead ECG. |
| Secondary | Fractional Shortening Percent | 36 months | Measured by trans-thoracic echocardiogram and 12-lead ECG. |
| Secondary | PR Interval | 36 months | Measured by trans-thoracic echocardiogram and 12-lead ECG. |
| Secondary | Participant Weight | 36 months | |
| Secondary | Participant Height | 36 months | |
| Secondary | Participant Body Mass Index | 36 months |
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.
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GET https://conductscience.org/api/trials/v1/NCT01603407/registered