Clinical Trial Search

Primary: Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint — 0.35 units on a scale — p=<0.001

Primary: Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period — 50.45; 49.75 percentage of days — p=0.63

Primary: Plasma Potassium — 4.0; 4.0; 4.1; 3.7 mmol/l — p=0.007

Primary: Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12 — -0.6; 0.7 Units on a scale — p=0.070

Primary: Area Under the Concentration-Time Curve(AUC) — 3.6; 3.4; 85.8; 79.2 hour*milligram/liter

Primary: Hemoglobin A1c (HbA1c) at 36 Week Endpoint — 7.66; 7.49 percent HbA1c — p=0.097

Primary: Percentage Change in Exercise Tolerance From Baseline at 2 Weeks — 68; 124 Percentage change — p=0.038

Primary: Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies — 164; 164; 162 Participants

Primary: Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% — 22.4; 8.8 percentage of participants — p=0.0499

Primary: Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug — 155; 150 milliliters (mL) — p=0.021

Primary: Change From Baseline in Rey Auditory Verbal Learning Test — 1.53; 1.00; 5.30; 4.02 number of words correctly recalled

Primary: Number of Joint Bleeds — 18.5; 1.5 Number of joint bleeds — p=<0.001

Primary: Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks — -13.7; -11.1 Scores on a scale — p=0.0077

Primary: Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies — 0; 22; 2; 21 subjects

Primary: Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) — 8.68; 7.87 points on a scale — p=<0.001