Clinical Trial Search

Primary: Overall Response Rate (Complete or Partial Response) by Month 12 — 60; 84 percentage of patients

Primary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants

Primary: The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 2 Hours After Dosing as Reported by the Subject in the eDiary — 51.0; 30.8 Percentage of…

Primary: ICU Transfer — 52; 51 participants

Primary: Patient Morphine Equivalent Consumption — 35.1; 50.5; 28.0; 29.6 mg

Primary: Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days — -2.38; -2.10; -1.69 units on a scale

Primary: Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6 — -0.4; -12.7 units on a scale — p=0.001

Primary: Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12 — 30.4; 33.2 percentage of subjects

Primary: Incidence of Adverse Events (AEs) — 98.5; 42.6; 68.9; 23.8 Percentage of patients (%)

Primary: Number of Participants Who Experience at Least One Adverse Events — 286 Participants

Primary: Number of Participants Experiencing Any Grade 2 or Higher AEs During Injection Phase — 59; 31 Participants

Primary: Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA) — 10.8 percentage of BMD change

Primary: Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale — 59; 56 units on a scale

Primary: Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire — 50.39; 45.25; 41.22…

Primary: Number of Participants With Complete Remission (CR) — 17; 19; 12; 13 Participants