Clinical Trial Search

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

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

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

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

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

Primary: Mean Dystrophin Levels as Measured by Electrochemiluminescence (ECL) — 0.0844; 0.1002; 0.1054 nanograms (ng)/mg

Primary: DB Period: Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 72 - Modified Intention-to-treat (mITT) Population — -81.83; -90.09 meters — p== 0.3626

Primary: Number of Participants With Unacceptable Toxicity. — 0 Participants

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

Primary: Restoration of Full-length Type VII Collagen as Assessed by Immunofluorescence. — 5; 5; 4; 4 Fluorescence Intensity (MFI) for C7

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 in Time to Stand (TTSTAND) Versus Matched Historical Controls — 0.17; -0.38; -0.11; 0.69 seconds

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

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

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

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 Adverse Events (AEs) — 4 Participants

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 Participants With Treatment-Emergent Adverse Events (TEAEs) — 5 Participants

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

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 4; 5; 3; 3 Participants

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious Adverse Events (SAEs) — 14; 5; 8; 1 Participants

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

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

Primary: Increase in Dystrophin Expression in the Muscle Biopsies by Immunofluorescence Analyses of Cross-sections and by Western Blot Analyses of Total Protein Extracts — 1; 1…

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