Clinical Trial Search

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: 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: Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6 — -1.87; -1.92; -1.21 score on a scale…

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: Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE) — 58.7 percentage of participants

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

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

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

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: Dynamic Component of Spasticity (Spasticity Angle) — 70; 60; 57.5 degree — p=<0.001

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

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

Primary: Change in Assisting Hand Assessment (AHA) — 6.4; 8; 5.5; 7.6 score on a scale

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

Primary: Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery — -2.4 normalized z-score

Primary: Change in Assisting Hands Assessment Logit Score at End of Treatment — 2.63; 4.33 Scores on a scale

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

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

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: Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG) — -0.3; -1.2; -1.4 units on a scale

Primary: Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Dissociated Movements — 3.5 units on a scale

Primary: Jebsen Taylor Hand Function Test for Dominant Hand — 130.1; 115.2 seconds

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: Change From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Test — 0.83; 0.00; 0.50; -0.05 score on a scale

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

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

Primary: Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the High-dose Groups…

Primary: Train of Four 0,9 (90%) — 49.9; 41.7 minutes

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