Clinical Trial Search

Primary: Change From Baseline in Daily Urine Volume — 481.0 ml

Primary: Annualized Rate of Decrease in Percent Predicted Forced Vital Capacity (FVC) Over 52 Weeks — -6.1876; -5.2065; -6.0430; -5.5430 percent predicted FVC/year — p=0.4555

Primary: Percentage of Participants With Response to Treatment Based on Hemoglobin Levels — 46.2 percentage of participants

Primary: Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33 — 330; 440; 329; 461 ng/mL

Primary: Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. — -1.84; -2.59; -3.17; -3.78 mg/dL

Primary: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) — 29.9; 30.2; 30.9 Score on scale — p=0.7408

Primary: Cmax — 340.4; 524.8; 348.4 ng/mL

Primary: Number of Participants That Experience Serious Adverse Events.

Primary: The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests — 99.5; 117.5 summed-ranks — p=0.25

Primary: Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off — 21; 28; 91; 103 Participants

Primary: Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period — 1.81; 1.61; 1.55; 0.92 Seizures per week — p==0.240

Primary: Functional Magnetic Resonance Imaging (fMRI) Changes in Response to Estrogen and Aging - Dorsolateral Pre-frontal Cortex (DLPFC) — 455.8; -214.4; -348.1; 90.1 linear…

Primary: Primary Outcome Measure: Time in Therapeutic Range — 74.1; 71.6 percentage of time

Primary: Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population — 33.3 Percentage of participants

Primary: Number of Participants With Negative Fungal Culture — 14; 2 Participants