Epilepsy Rescue Therapy with USL261 Spray: The ARTEMIS-1 Study – Phase III

Study of the Safety and Efficacy of Intranasal Midazolam (USL261) in the Outpatient Treatment of Subjects with Seizure Clusters

Protocol Description

The purpose of this multicenter study is to learn about the investigational drug midazolam and its impact on control of seizure clusters when taken as a nasal spray by adolescents and adults with epilepsy. When given intravenously, midazolam is approved for use as an anesthetic and sedative, and researchers believe the liquid formulation of intranasal midazolam (USL261) may be effective for treatment of seizure cluster episodes. The study sponsors have nicknamed this study ARTEMIS-1, for Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray-1.

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 a diagnosis of epilepsy that includes a history of seizure clusters occurring in an observable pattern. Participants must have an adult caregiver who can recognize and observe the participant’s seizure cluster episode.
Males and Females: Ages 12 years and older


At the initial screening visit, participants will receive a medical exam, including blood tests, and a patient management plan will be initiated. Participants will return to the study center for a second visit in which test doses of midazolam will be administered under observation by the research team. At the third study visit, each participant will be provided with a kit containing either two doses of the study drug or a placebo dose and a dose of the study drug. The kit is to be taken home and administered by the caregiver when a seizure cluster occurs, in accordance with instructions provided by the research team. The fourth and final visit occurs within 1 to 5 days of when the study drug was administered for seizure treatment.
Visits: 4
Duration: Up to 8 months

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