Clinical Trial Search

Primary: Percent Change From Baseline in Calculated LDL-C at Week 24 - ITT Analysis — -6.6; -45.7 percent change — p=<0.0001

Primary: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 — -1.22; -3.92 unit on a scale — p=0.0915

Primary: Young Mania Rating Scale (YMRS) — 25.09; 30.59; 15.24; 10.22 units on a scale — p=<0.01

Primary: No Emetic Episodes and No Rescue Medication — 71.3; 61.6 percentage of particpants — p=<0.001

Primary: No Emetic Episodes and No Rescue Medication — 72.7; 58.4 percentage of participants — p=<0.001

Primary: Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine. — 42; 47; 41; 38 percentage of Subjects

Primary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis — 9.1; -48.8 percent change — p=<0.0001

Primary: No Emetic Episodes and No Rescue Medication — 70.1; 61.9 percentage of participants — p=0.043

Primary: Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events — 90.8; 9.2; 52.3 percentage of participants

Primary: Number of Subjects Reporting Unsolicited Adverse Events (AEs). — 0; 0; 0; 0 Subjects

Primary: Variability of Intracranial Pressure (ICP) — 5.66; 5.61 mmHg

Primary: Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4 — -0.86; -0.83; -1.00; -1.18 nocturnal voids — p=0.9303

Primary: Progression-free Survival — 9.90; 6.20; 12.30; 7.20 Months — p=0.0001

Primary: Rectus Femoris Cross Sectional Height — 17.5; 17.6 cm

Primary: Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24 — -0.66; -0.65; 0.13 Percent HbA1c — p=<0.001