Trial · NCT07070999
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-related adverse events (AEs) and serious adverse events (SAEs) at Grade 3 or higher as characterized by CTCAEv5.0 | Up to 18 months across multiple visits | Assess the number of treatment-related AEs and SAEs as characterized by CTCAEv5.0 |
| Primary | Number of Participants with Clinically Significant Changes in Physical Functions | Up to 18 months across multiple visits | Assess the number of participants with clinically significant changes in physical functions. |
| Primary | Number of Participants with Clinically Significant Changes in Neurological Functions | Up to 18 months across multiple visits | Assess the number of participants with clinically significant changes in neurological functions. |
| Primary | Number of Participants with Clinically Significant Changes in Vital signs | Up to 18 months across multiple visits | Assess the number of participants with clinically significant changes in vital signs. |
| Primary | Change in electrocardiogram results | Up to 18 months across multiple visits | ECG will measure RR interval, P Wave, PR interval, PR segment, QRS Complex, ST segment, T wave and QT Interval. |
| Primary | Change in serum cardiac troponin I levels | Up to 18 months across multiple visits | |
| Primary | Number of Participants with Clinically Significant Laboratory Abnormalities as Measured Using Hematology, Chemistry and Coagulation Tests | Up to 18 months across multiple visits | Assess the number of participants with clinically significant laboratory changes including hematology, serum chemistry, and coagulation tests. |
| Primary | Number of Participants with Clinically Significant Laboratory Abnormalities as Measured Using Urine and CSF Tests | Up to 18 months across multiple visits | Assess the number of participants with clinically significant laboratory changes including urine and CSF tests. |
| Primary | Change in markers of immunogenicity | Up to 18 months across multiple visits | Assessment of humoral (NAb and TAb titers) and T-cell (IFNγ ELISpot) immune responses to the AAVhu68 capsid and SMN transgene product in serum and CSF. |
| Secondary | Assess the number of participants who experience permanent ventilation or death | Up to 18 months across multiple visits | |
| Secondary | Percentage of infants with improvement in the motor milestones categories in Section 2 of the Hammersmith Infant Neurological Examination (HINE), with the exclusion of voluntary grasp. | Baseline, 6 months and 18 months post dose. | * improvement in at least one category, i.e., an increase in the score for head control, rolling, sitting, crawling, standing, or walking of ≥1 point, * an increase in the score for kicking of ≥2 points, or achievement of the maximal score for kicking. |
| Secondary | Change from baseline in mean Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) Score. | Baseline, 6 months and 18 months post dose. | Assess 16 types of muscle movements, each given a score from zero (the person can't complete the movement) to 4 (the person can complete the movement on their own, without assistance) to produce a score of 0 to 64. |
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/NCT07070999/registered