Midazolam nasal spray for treatment of epilepsy (seizure clusters)
Brief Description Of Study
Midazolam is approved by the FDA in the United States to be given by an injection in the vein or muscle. In this study a spraying device will be used to spray midazolam in the nose. The purpose of this study is to learn more about how safe intranasal midazolam is, how many side effects it may cause and how well it controls seizure clusters when added to a subject's current antiepileptic drugs.
Detailed Study Description
During the double-blind study, subjects will receive 2 doses of the study drug (intranasal midazolam) in the clinical research facility at Penn. During the open-label study, subjects will treat seizure clusters at home with the study drug and return for research visits after every 1-2 treatments. Subjects have to have recognizable seizure clusters (acute repetitive seizures). They cannot be taking any chronic benzodiazepines, and they must have a caregiver, friend or relative join the research study with them. Caregivers will be trained how to administer the study drug. General study evaluations include the collection of medical and epilepsy history, vital signs, physical and neurological exams, ECG, blood and urine sample collection and questionnaires. In addition to caregiver training for study drug administration, breathing counts, and rescue airway management, the subject/caregiver and study doctor will develop a personalized document to tell the caregiver how to recognize a treatable seizure cluster, when to administer the study drug and what to do in case of an emergency. They will be asked to complete a workbook for the treatment at home.
Additional Information About The Study
This study takes place at the University of Pennsylvania campus in the Neuroscience Center and the Clinical and Translational Research Center in Philadelphia. Subjects will be compensated $75 per visit.