Clinical Trial Search

Primary: Muscle, Nerve, or Vascular Damage — 16 participants

Primary: Incidence of Treatment-Emergent Adverse Events — 14; 9; 10 Participants

Primary: Change From Baseline in 6MWD at Week 48 — -41.81; -12.86; -42.56 meters — p=0.4756

Primary: Fasting Glucose — 93; 102 mg/dL

Primary: Number of Participants With Adverse Events Related to AVI-4568 — 0; 0 Participants

Primary: Change From Baseline in 6MWD at Week 48 — -60.67; -47.69 meters — p=0.213

Primary: Number of Subjects With an Adverse Event. — 1; 0; 0; 0 participants

Primary: Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month) — 4.8 units on a scale

Primary: Change in BMI — 0.67; 1.34; 1.8 kg/m^2

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 3; 6; 6; 5 Participants

Primary: Number of Participants With Adverse Events — 2; 1; 5; 4 Participants

Primary: Difference in 6-Minute Walk Distance Between Groups (Control Minus IGF-1) for Change at 6 Months Versus Baseline — 3.4; -5.1 meters — p=0.53

Primary: Patient-reported Stiffness on the IVR — 2.53; 4.21; 1.60; 5.27 units on a scale — p=<0.001

Primary: 12-month Change in Myocardial Strain — 2.2; 1.0 percent change in heart dimension

Primary: Mean Change From Baseline in Muscle Function Using the 6 Minute Walking Distance — -10.98; -19.93; 16.12 Meters — p=0.554

Primary: Body Composition (Body Fat) — 172.1; 232.7; 180.2; 274.8 g/Kg of body weight — p=<0.05

Primary: Forced Vital Capacity — 1.4; 1.4; 1.5 liters — p=0.3904

Primary: Number of Dose Limiting Toxicity (DLT) Adverse Events as Assessed by 21 CFR 312.32. — 0 Number of Events

Primary: Time to Sedation Score of 3-4 — 3.7; 2.8 minutes

Primary: Age of Participants When They Failed to Walk — NA; 14.4; 14.4; 11.1 Years

Primary: Percent Change in Range of Motion From Baseline to 180 Days — 67; 33 percentage of change

Primary: Change in FVC (%-Predicted) From Baseline to 2 Years. — -9.2; -6.4 Mean difference in FVC %-predicted — p=0.68

Primary: Change From Baseline in Muscle Tissue PGC1alpha (AU) at 8 Weeks — 0.55; 0.86 AU — p=0.0434

Primary: Left Ventricular Strain — 0.2; 0.4 Percent change in circumference — p=0.5867

Primary: Percent Change From Baseline in Dystrophin Level at Week 40, as Measured by ECL — 6.559 percent change

Primary: Number of Unanticipated Grade III or Higher Treatment-Related Toxicities — 0; 0 events

Primary: Change From Baseline in Muscle Function Using the 6 Minute Walking Distance (6MWD) Test Assessed at Week 48 — -52.65; -42.32 Meters — p=0.415

Primary: Change From Baseline to Week 24 in Distance Walked as Assessed by the Six-minute Walk Test (6MWT) Distance — 12.40; 20.11 meters

Primary: Part 1: Change From Baseline in North Star Ambulatory Assessment (NSAA) Total Score at Week 52 — 2.57; 1.92 scores on a scale — p=0.2441

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 91; 31; 26 Participants