Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters (ARTEMIS1)
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|ClinicalTrials.gov Identifier: NCT01390220|
Recruitment Status : Terminated
First Posted : July 8, 2011
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: USL261 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||292 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Intranasal Midazolam (USL261) in the Outpatient Treatment of Subjects With Seizure Clusters. ARTEMIS-1: Acute Rescue Therapy in Epilepsy With Midazolam Intranasal Spray-1|
|Actual Study Start Date :||June 2011|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
intranasal midazolam 5mg
Other Name: Midazolam nasal spray (MDZ NS)
- Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP) [ Time Frame: 6 hours ]Treatment Success is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after double-blind study drug administration, and 2) no recurrence of seizure(s) beginning 10 minutes after study drug administration to 6 hours after study drug administration. Participants who received the open-label second dose within 6 hours of administration of the double-blind dose were analyzed as having had a seizure.
- Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose [ Time Frame: 4 hours ]Participants with recurrence of seizure(s) >10 minutes and up to 4 hours after administration of the double-blind dose in the CP. Participants who received the open-label second dose within 4 hours of administration of the double-blind dose were analyzed as having had a seizure.
- Occurrence of and Time to Next Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose [ Time Frame: 24 hours ]Time to next seizure with a start time >10 minutes and up to 24 hours after administration of the double-blind dose in the CP. Participants who did not have another seizure before the end of the 24-hour observation period were censored at the end of the observation period. Participants administered the open-label second dose who did not have a seizure were censored at the time of the administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390220
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