NCT01529034

Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters

An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects With Seizure Clusters

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

Detailed description

Participants who completed study P261-401 (NCT01390220), a randomized double-blind study of USL261 (intranasal midazolam) versus placebo to acutely treat a seizure cluster episode, were eligible to to enroll in this open-label extension study (P261-402). The participant's caregiver administered a USL261 5 milligram (mg) dose for a seizure episode meeting study criteria. A second USL261 5 mg dose could be administered after 10 minutes and up to 6 hours after the first dose for persistent or recurrent seizures, unless the participant met exclusions to administration of the second dose. A participant could have more than 1 seizure cluster episode treated during his/her study participation.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	USL261

Timeline

• Start date: 2012-07-01
• Primary completion: 2017-04-01
• First posted: 2012-02-08
• Last updated: 2023-01-20
• Results posted: 2019-06-25

Locations

58 sites across 10 countries: United States, Australia, Canada, Germany, Hungary, Israel, New Zealand, Poland, Spain, Ukraine