Clinical Trial Search

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

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: Number of Participants With Adverse Events Related to AVI-4568 — 0; 0 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: Change From Baseline in 6MWD at Week 48 — -60.67; -47.69 meters — p=0.213

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

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

Primary: Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) — 15.1; 33.9; 20.6; 481.2 nM — p=0.0482

Primary: Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE) In Participants With Duchenne Muscular Dystrophy — 3; 5 Participants

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

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

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

Primary: Incidence of Adverse Events as Assessed by CTCAE v4.0. — 3; 4; 4; 5 Participants

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

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

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

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

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

Primary: Baseline for the North Star Ambulatory Assessment (NSAA) Total Score — 23.1; 24.5; 22.7 score on a scale

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation — 26; 5; 4; 0 Participants

Primary: Change From Baseline in North Star Ambulatory Assessment (NSAA) — -1.5; -1.8 score on a scale

Primary: Change From Baseline in Time to Stand (TTSTAND) Versus Matched Historical Controls — 0.17; -0.38; -0.11; 0.69 seconds

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

Primary: Number of Participants With Treatment Emergent Adverse Events — 24 Participants

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

Primary: Mean Change From Baseline to 24 Weeks in the 6-minute Walk Distance (6MWD) — -3.5; -7.5; -17.0 meter

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: Incidence of Adverse Events — 0; 3; 1; 1 participants