Overview

Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting

Status:
Completed

Trial end date:
2020-10-13

Target enrollment:

Participant gender:

Summary

The purpose of this study is to determine if the investigational treatment, MHOS/SHP615, is safe and effective in children with status epilepticus (SE) (convulsive) in the community setting. This study is open-label extension for patients who completed the SHP615-301 study and who tolerated and responded to MHOS/SHP615 treatment in the hospital setting.

Phase:

Phase 3

Details

Lead Sponsor:

Shire

Collaborator:

Takeda Development Center Americas, Inc.

Treatments:

Midazolam
Pharmaceutical Solutions