Clinical Trial Search

Primary: Change From Baseline in the Ashworth Scale (AS) Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle (1st IC) — -0.7; -0.66…

Primary: Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus — -0.08; 0.00; -0.09; -0.01 ml/kg*m

Primary: Change in Muscle Size Parameter — 3.7; 1.6; 1.4; 0.1 milliliters — p=<0.01

Primary: MP: Change From Baseline in Ashworth Scale (AS) in UL Primary Clinical Target Pattern at Week 4 — -0.93; -1.15; -0.96; -1.02 Unit on a scale — p== 0.017

Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Reported in the Double Blind (DB) + Open Label (OL) Period. — 177; 5; 91; 151 participants

Primary: Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle — 53; 44; 26; 31 participants

Primary: Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb — -0.86; -0.97; -0.48 units on a scale — p=0.0029

Primary: Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG — -1.5; -1.9; -2.2 score on a scale — p=0.0118

Primary: Oxygen Consumption (ml/kg/Min) — 14.82; 16.75; 28.77 ml/kg/min

Primary: Change in Head Holding Active Time From Baseline to 6 Months — 83.63 Seconds

Primary: Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score — 4 Participants

Primary: Ankle Passive Range of Motion — 8.3; 10.4 degree

Primary: Congruent Trial (Hearts) Accuracy — 87.96; 87.50 percentage of correct

Primary: Change From Baseline in the Movement Disorder-Childhood Rating Scale (MD-CRS) Part II Total Score (Movement Disorder Severity, Centrally Read) at Week 15 — -0.4; -1.5…

Primary: Step Width — 10.4 cm

Primary: Unit on Gross Motor Function Measure Scale (GMFM) — 5.12; 2.00 units on a scale — p=0.007

Primary: Self-Selected Velocity (SSV) — 0.41; .48; 0.48; 0.52 m/s

Primary: Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb — 2 percentage of muscle synergies

Primary: Pediatric Balance Scale (PBS) Mean Group Score — 48.43; 49.43 score on a scale — p=<0.05

Primary: Sitting Assessment Scale — 12.56; 15.06 units on a scale — p=0.001

Primary: Bone Structure — 10.4; 7.6; 6.7; 9.0 percent change

Primary: Change in Self-selected Gait Speed (Normalized) — -0.0010; 0.0163 dimensionless

Primary: Gross Motor Function Measure Dimension E — 15.6; 12.7; 18.7; 17.1 score on a scale

Primary: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) — 65.4 percentage of participants

Primary: First Scoliotic Curve — 71.4029 degrees

Primary: Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6 — -1.06; -1.01; -0.80 score on a scale — p=0.010

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

Primary: Dynamic Gait Index (DGI) — 19; 24; 18.5 units on a scale — p=<0.01

Primary: Changes in pVO2 — 1.72; -0.61 mL/kg-1/min-1

Primary: Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics — 0.41; -0.48 units on a scale — p=0.36