Study and Safety and Effects of Midazolam Nasal Spray for the Treatment of Seizure Clusters in the Epilepsy Monitoring Unit (EMU)

What we are studying

The purpose of this research study is to evaluate the efficacy (how well does it work, does it work), safety (look at side effects), and tolerability (would you take it again if you could) of Midazolam Intranasal Spray compared with that of a placebo administered through the nose (intranasal) for the treatment of intermittent bouts of increased seizure.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 12 - 65

Eligibility Criteria

  • The subject has to be admitted the the EMU or have a planned admission within 28 days
  • Body weight is ? 40 kg to ? 125 kg
  • Has an established diagnosis of partial or generalized epilepsy.

What is involved

  • Medical history
  • Medications
  • Physical Examination
  • Nasal Exam
  • Neurolgoical exam
  • Blood testing
  • Saliva Sample
  • Urine testing
  • Pregnancy Testing
  • ECG
  • Questionnaires

Contact Information

Study Coordinator
Janet Hutchens
Email
jahutche@wakehealth.edu
Phone
336-716-1715
Principal Investigator
Jane Boggs, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.