Phase 1 N=56 Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation
Epilepsy
Primary: Cmax - Maximum Observed Plasma Concentration of 9-1067 — 600; 567; 955; 917 ng/mL
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=6 An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites
Parkinson's Disease (PD)
Primary: Cumulative Recovery of [14C]-Radioactivity — 12.8; 67.2; 15.9; 95.9 Recovery % of dose
Phase 1 N=25 Effect of Rasagiline on BIA 9-1067 Pharmacokinetics
Parkinson Disease
Primary: Cmax - Maximum Observed Plasma Drug Concentration — 647; 703; 640; NA ng/mL
N/A N=35 The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception
Pregnancy · HIV · AIDS
Primary: AUC Norethindrone — 37.81; 25.21 ng*h/mL — p=<0.05
Phase 1 N=27 Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide
Parkinson Disease
Primary: Cmax - Maximum Observed Plasma Concentration — 400; NA; 11.6; 9.76 ng/mL
Phase 1 N=24 A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis
Rheumatoid Arthritis
Primary: Number of Participants With Clinically Significant Clinical Laboratory Results — 3; 0; 1; 1 participants
Phase 4 N=53 Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures
Pain
Primary: Pre Procedure 0 - 10 Pain Numerical Rating Scale — 0; 0; 7; 5 0 - 10 Pain Numerical Rating Scale
Phase 4 N=353 Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy
Epilepsy
Primary: Percentage of Subjects With a Treatment Failure — 12.7; 23.4 percentage of subjects
Phase 2 N=38 Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients
Post-operative Pain · Respiratory Depression
Primary: Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. — 49; 29; 54; 35 IV morphine equivalency in mg — p=0.03
Phase 1 N=24 Effect of BIA 9-1067 on Rasagiline Pharmacokinetics
Parkinson Disease
Primary: Cmax - Maximum Observed Plasma Concentration — NA; 672; 643; 6152 ng/mL
Phase 1 N=82 Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic
Parkinson Disease
Primary: Cmax - Maximum Plasma Concentration of Levodopa — 1076; 1106; 943; 981 ng/mL
N/A N=203 Educational Intervention in Pharmacovigilance for Hospital Health Professionals
Adverse Drug Reaction
Primary: Absolute Number of ADE Reporting (Change Behavior of Health Professionals) — 215; 3 absolute number of adverse drug events
Phase 4 N=68 A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris
Acne Vulgaris
Primary: Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician — 2.8; -1.2 score on a scale
N/A N=87 Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
Combat Disorders · Post-traumatic Stress Disorder
Primary: PTSD Checklist (PCL) — 57.46; 59.98; 47.00; 58.06 units on a scale
N/A N=300 The Evicel Post-Authorization Surveillance Study
Peripheral Vascular Disease · Hemorrhage
Primary: Specific Safety Parameters — 12; 7; 0 participants