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SAGE


Title 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
Therapeutic Area Seizures
Principal Investigator Kimberly Parkerson, MD
Min Age 18 Years
Gender Both
Contact Haley Huggins
617-636-7606
More Information https://clinicaltrials.gov/ct2/show/NCT02052739

Overview

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 patients in super-refractory status epilepticus (SRSE). SAGE-547 Injection (SAGE-547) is an investigational drug being studied in patients with continuous seizures (seizures that have little or no break between them) that do not respond to seizure medications.

Study Details

Inclusion Criteria

  • Subjects 18 years of age and older.
  • Failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment), according to institution standard of care
  • Failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AED), according to institution standard of care

Exclusion Criteria

  • Subjects who are pregnant.
  • Subjects with a known allergy to progesterone or allopregnanolone or any excipients in SAGE-547.
  • Subjects with SRSE due to anoxic/hypoxic encephalopathy.

Study Requirements

The patient’s participation in this study could last up to 36 days and potentially include 20 study visits based on the required treatment for inpatients only. Several evaluations of the patient’s level of consciousness/drowsiness, overall condition and improvement, mental ability, and outcome. The electrical activity of the patient’s brain will be monitored with an Electroencephalogram (EEG). If the EEG remains for the duration of the patient’s participation, only information collected from the EEG at some of the study visits will be used for the study. Blood samples will be collected at different time points to assess the amount of allopregnanolone (active ingredient in SAGE-547) and its break-down products in the patient’s blood.