A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SAGE-547 INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS Save

Date Added
July 28th, 2015
PRO Number
Pro00044382
Researcher
Ekrem Kutluay
Keywords
Epilepsy
Summary

The purpose of the study is to find out if SAGE-547 has any effect on continuous seizures and if it is safe to use in subjects in super-refractory status epilepticus (SRSE). Subjects in SRSE have continuous seizures that will not stop even after they have been given seizure medications that are expected to cause the seizures to stop. Subjects in SRSE are given anesthetic medications that make them unconscious in order to control the seizures. This is thought to help lessen the damage to the brain caused by the seizures and to reset the brain to try to stop the seizures.

If the subject continues to have continuous seizures during the 24 hours following the end of the initial treatment period, the subject may be eligible to receive the active study drug (SAGE-547) during the retreatment period. The study doctor will determine if the subject is eligible for the retreatment period, and the decision to retreat the subject will be discussed with you. The retreatment period is open-label, meaning the study doctor, the subject, and you will know that SAGE-547 (active substance) will be given. The length of the retreatment period will be identical to the initial treatment. Subjects who are eligible for the retreatment period will have more visits and be in the study longer than subjects who only receive the initial treatment.

As a part of this study, information will be collected on how much allopregnanolone (the active ingredient in SAGE-547) is present in the subject?s blood during the study, and whether SAGE-547 affects the subject?s level of consciousness/drowsiness, mental ability, overall condition, outcome and improvement.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
843-792-3855
hamrickr@musc.edu

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