Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage
This is a Phase 1/2a multicenter, controlled, open label, and randomized, study. Part 1 of the study is a single dose escalation period to determine the MTD of EG-1962. During this period, a maximum of 6 dose level cohorts with up to 12 patients per cohort will be enrolled. In each cohort, patients will be randomly assigned in a ratio of 3:1 to receive either intraventricular EG 1962 or enteral nimodipine, respectively. The first cohort will receive 100 mg EG 1962. Upon completion of the dose escalation period, a safe and tolerable dose will be selected for further study. Part 2 of the study is a treatment period to assess the safety and tolerability of the selected dose of EG-1962. The safety and tolerability of a single intraventricular dose of EG 1962 will be compared to enteral nimodipine (60 mg given every 4 hours orally or via nasogastric or gastrostomy tube) for 21 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Based upon Investigator Judgement
Based upon Investigator Judgement
Barrow Neurological Institute
Phoenix, Arizona, United States
Dose Escalation Period
To determine the maximum tolerated dose (MTD) of intraventricular EG 1962.
Time frame: 3 Months
PK measurements
To measure plasma and cerebrospinal fluid (CSF) concentrations of nimodipine
Time frame: 3 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Maryland Medical Cnter
Baltimore, Maryland, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Overlook Medical Center
Summit, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
...and 13 more locations