Epilepsy Rescue Therapy with USL261 Over a Long-Term – Phase III

Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters

Protocol Description

This study is an extension of the related ARTEMIS-1 study, that evaluates the investigational drug midazolam for its impact on the control of seizure clusters when taken as a nasal spray by adolescents and adults with epilepsy. Researchers believe the liquid formulation of intranasal midazolam (USL261), may be effective for treatment of seizure cluster episodes. Through this extension, participants may use the investigational drug for up to 4 years.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting people of both genders, ages 12 and older, who have completed the ARTEMIS-1 study. As with ARTEMIS-1, participants must have a diagnosis of epilepsy that includes a history of seizure clusters occurring in an observable pattern, and have an adult caregiver who can recognize and observe the participant’s seizure cluster episodes.
Males and Females: Ages 12 years and older


After screening and physical examinations, participants’ caregivers will be provided with kits containing dosages of the study drug. The medicine is to be administered by the caregiver when a seizure cluster occurs, in accordance with instructions provided by the research team, keeping a workbook journal of information about when seizures occur and how the patient responds. Follow up visits, which will include provision of new kits, will be required after the first treated seizure cluster and after every other seizure cluster thereafter until the final visit.
Visits: Dependent on number of cluster seizures that occur
Duration: Up to 4 years

Status: Open to Enrollment

Source(s) of Support

Upsher-Smith Laboratories

Primary Investigator

Inna Ilana Vaisleib, MD

Contact Information

For more information about the study or enrollment, please contact:
Jennifer Monahan, Clinical Research Coordinator