Safety/Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With aSAH
Phase 1
Terminated
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Interventions
- Drug: EG-1962 (nimodipine microparticles)
- Registration Number
- NCT02893826
- Lead Sponsor
- Edge Therapeutics Inc
- Brief Summary
Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Ruptured saccular aneurysm repaired by neurosurgical clipping
- Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale
- WFNS grade 1 or 2 assessed during the Pre-randomization Phase. If WFNS grade 2, must not require an EVD prior to aneurysm repair
Exclusion Criteria
- Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm
- Angiographic vasospasm prior to randomization
- Evidence of cerebral infarction with neurological deficit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EG-1962 Group EG-1962 (nimodipine microparticles) 1 dose of intracisternal EG-1962 (nimodipine microparticles) 600 mg Enteral Nimodipine Group Enteral Nimodipine Up to a total of 21 days of enteral nimodipine (including nimodipine received prior to randomization)
- Primary Outcome Measures
Name Time Method Proportion of subjects with delayed cerebral infarctions present on CT at Day 30 30 Days Incidence and severity of adverse events 90 Days
- Secondary Outcome Measures
Name Time Method Pharmacokinetic (PK) profile of EG-1962 as measured by time to reach maximum drug concentration in plasma (Tmax) 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) 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) 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 14 (AUC0-14) 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 Day 10 (AUC0-10) 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 Pharmacokinetic (PK) profile of EG-1962 as measured by maximum drug concentration in plasma (Cmax) 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 from 0 to last plasma concentration (AUC0-last) 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
Trial Locations
- Locations (4)
University of Alberta Hospital/Mackenzie Health Sciences Centre
🇨🇦Edmonton, Alberta, Canada
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