Safety and effectiveness of long‐term treatment with diazepam auto‐injector administered by caregivers in an outpatient setting for the treatment of acute repetitive seizures

• Published in: Epilepsia (Copenhagen) 2014-09, Vol.55 (9), p.1444-1451
• Main Authors: Rogin, Joanne, Wheless, James, Abou‐Khalil, Bassel, Wolter, Kevin D., Pixton, Glenn C., Sherman, Nancy A., Shukla, Rajesh B., Roland, Carl L., Sommerville, Kenneth W.
• Format: Article
• Language: English
• Subjects: Acute Disease; Adolescent; Anticonvulsants - administration & dosage; Autoinjection; Benzodiazepines; Caregivers - psychology; Child; Clinical trial; Cluster seizures; Diazepam - administration & dosage; Double-Blind Method; Drug Delivery Systems; Drug therapy; Emergency medical care; Female; Follow-Up Studies; Humans; Male; Outpatients; Seizures - drug therapy; Serial seizures; Treatment Outcome
• ISSN: 0013-9580; 1528-1167
• DOI: 10.1111/epi.12685

Summary Objective Part 1 of this phase III study was a randomized, double‐blind, parallel‐group, placebo‐controlled, multicenter study of caregiver administered diazepam auto‐injector (AI) in subjects with acute repetitive seizures (ARS) and demonstrated that diazepam AI was well‐tolerated and significantly more effective than placebo AI in delaying the time to next seizure or rescue. Part 2 of this study, presented herein, was an open‐label continuation to assess the long‐term safety and effectiveness of diazepam AI for the treatment of ARS. Methods Of the 234 subjects randomized in part 1, 161 continued into part 2 and were provided open‐label diazepam AI. Effectiveness measures were time to next seizure or rescue, number of subsequent rescues by type (rescue medication, emergency room visit, or other medical care), and number of subsequent seizures during the 12‐h follow‐up period. Safety data (adverse events and respirations