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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

Learn More About These Conditions

More information about Epilepsy

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