Pharmacodynamics of Nasal and Buccal Midazolam Using EEG
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | July 2011 |
| End Date: | April 2012 |
| Contact: | Derek Chong, MD |
| Email: | dc2223@columbia.edu |
| Phone: | 212 305 1742 |
Comparing the Pharmacodynamics of Nasal and Buccal Midazolam Using EEG
Approximately 3 million individuals suffer from epilepsy in America alone and about 200,000
new cases of epilepsy in America are diagnosed each year (Epilepsy Foundation, 2005).
Epilepsy can be defined as a condition in which a person has recurrent, unprovoked seizures.
Prolonged or back-to-back repetitive seizures, known as "acute repetitive seizures" (ARS),
are medical emergencies. ARS can occur unexpectedly, a circumstance for which quick and
efficient antiepileptic drugs are needed for household and prehospital use. Currently,
benzodiazepines are the antiepileptic drug of choice when dealing with ARS because they are
proven to be efficient and take little time to work. Benzodiazepines can be administered by
mouth, by vein via a needle (intravenously; IV), rectally, between the cheek and gum
(buccally), or in the nose (intranasally; IN). The nasal formulation is not yet
FDA-approved. The rectal treatment route has been commonly used for acute seizure treatment
in past years, but recent studies propose that the nasal route for benzodiazepines may be
better overall for home treatment and easier to administer (see Wermeling, 2009). For many
"out of hospital" situations, nasal benzodiazepines can be more convenient and more
comfortable than rectal treatment. In addition to the above benefits, nasal benzodiazepines
are rapidly absorbed by the blood vessels in the nose and the time of drug administration
and cessation of seizures may thus be reduced using nasal routes. This study sets out to
characterize how fast buccal and nasal treatments begin to work on the brain by monitoring
brain waves during administration of the drug, and to determine whether nasal or buccal
administration is best.
Past out-of-hospital treatments for acute epileptic seizures have met with limited
effectiveness, convenience, speed, and safety. The only FDA-approved treatment for acute
repetitive seizures must be given rectally, but nasal or buccal midazolam have been shown to
be at least as effective. The purpose of this study is to characterize the time to effect on
brain activity of intranasal (or nasal) midazolam and compare it with buccal midazolam. This
research will recruit patients with epilepsy who are undergoing EEG recordings for clinical
purposes, including those with intracranial EEG. EEG will be evaluated during
administration of buccal or nasal midazolam for augmentation of beta waves signifying action
of midazolam on the brain, and the time to effect will be compared between buccal and nasal
formulations. Subjects will be given a brief survey after the administration to evaluate
sedation, discomfort and other adverse effects of the medication. This study will help
characterize the action of nasal and buccal benzodiazepines and to determine the most
effective method of administration.
Inclusion Criteria:
- adults undergoing extracranial EEG in an Epilepsy Monitoring Unit
- adults undergoing intracranial EEG in an Epilepsy Monitoring Unit
- adults with chronically implanted intracranial neurostimulators with the capacity for
continuous intracranial EEG monitoring
Exclusion Criteria:
- any patient on additional sedative medications (narcotics, other central nervous
system depressants)
- any patient with documented sensitivity or adverse reaction to any benzodiazepine
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