Study of the Safety and Efficacy of Intranasal Midazolam in the Treatment of Subjects with Seizure Clusters

What we are studying

The purpose of this study is to learn about the safety of USL261 (intranasal midazolam) and the effects of USL261 on your seizures when the seizures occur one after the other in clusters (seizure cluster)

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+

Eligibility Criteria

  • Have a diagnosis of partial or generalized epilepsy
  • Weigh between 40 kg to 125 kg (88 lbs to 275 lbs)
  • Not be pregnant or planning to become pregnant
  • Not be allergic to midazolam
  • Not have changed anti-epileptic medications dose and/or medications recently

What is involved

  • The study is divided into 2 parts and will involve up to 4 planned visits to the study doctor. Telephone calls will be done as applicable (up to 6 calls).

Compensation

None

Contact Information

Study Coordinator
Jessica Dimos
Email
jdimos@wakehealth.edu
Phone
336-716-8694
Principal Investigator
Cormac O'Donovan, 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.