RAISE: A Study of Ganaxolone for Treatment of Status Epilepticus
Research Question:
What is the efficacy and safety of IV ganaxolone for the treatment of Status Epilepticus
(after failure of first-line benzodiazepines and two second-line IV antiepileptic
drugs)?
Basic Study Information
Purpose:
Potential participants may be identified in the emergency department, ICU or other
units in the hospital, and will be consented/assented and then screened for inclusion/exclusion
criteria prior to being randomized to start IP treatment. Investigational product
(ganaxalone) will be administered as a 3-minute bolus that will be started with a
continuous IV infusion lasting for 36 hours and followed by a 12- hour taper. After
the Investigational Product has been discontinued, the follow-up period assessments/procedures
will be collected every 24 hours through 120 hours and at the time of hospital discharge
followed by weekly visits/contacts at Week 1, 2, 3 and 4. Males or females aged 18
or older and admitted to the hospital in a state of status epilepticus are eligible.
Patients with a history of status epilepticus may pre-consent to participate in the
study.
Location: University of Rochester Medical Center - Strong Memorial Hospital
Study Reference #: 5459
Lead Researcher (Principal Investigator)
Lead Researcher:
Trenton Tollefson
Study Contact Information
Study Coordinator: Noreen Connolly
Phone: (585) 275-0589
Email: noreen_connolly@urmc.rochester.edu
Additional Study Details
Reimbursement:
No
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