Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Dignity Health; St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
University of California San Francisco
San Francisco, California, United States
University of Maryland Medical Systems
Baltimore, Maryland, United States
University of Alberta Hospital/Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Incidence and severity of adverse events
Time frame: 90 Days
Proportion of subjects with delayed cerebral infarctions present on CT at Day 30
Time frame: 30 Days
Pharmacokinetic (PK) profile of EG-1962 as measured by maximum drug concentration in plasma (Cmax)
Time frame: At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30
Pharmacokinetic (PK) profile of EG-1962 as measured by time to reach maximum drug concentration in plasma (Tmax)
Time frame: At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30
Pharmacokinetic (PK) profile of EG-1962 as measured by steady state concentration (Css)
Time frame: At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30
Pharmacokinetic (PK) profile of EG-1962 as measured by AUC area under the plasma concentration-time curve (AUC) from 0 to 24 hours (AUC024h)
Time frame: At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours
Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 10 (AUC0-10)
Time frame: At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to Day 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 14 (AUC0-14)
Time frame: At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to Day 14
Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to last plasma concentration (AUC0-last)
Time frame: At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to last plasma concentration