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

PHASE3CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

April 23, 2018

Primary Completion Date

October 13, 2020

Study Completion Date

October 13, 2020

Conditions
Nervous System Diseases
Interventions
DRUG

SHP615

SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg).

DRUG

MHOS/SHP615

MHOS/SHP615

Trial Locations (23)

400-8506

Yamanashi Prefectural Central Hospital, Kofu

060-8648

Hokkaido University Hospital, Sapporo

701-0304

NHO Minami-Okayama Medical Center, Okayama

276-8524

Tokyo Women's Medical University Yachiyo Medical Center, Yachiyo

420-8688

Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka

813-0017

Fukuoka Children's Hospital(NW), Fukuoka

500-8717

Gifu Prefectural General Medical Center, Gifu

063-0005

NHO Hokkaido Medical Center, Hokkaidō

861-1196

Kumamoto Saishunso National Hospital, Kumamoto

856-8562

NHO Nagasaki Medical Center, Nagasaki

950-2085

NHO Nishi Niigata Chuo National Hospital, Niigata

700-0914

Okayama University Hospital, Okayama

535-0022

Nakano Children's Hospital, Osaka

594-1101

Osaka Women's and Children's Hospital(NW), Osaka

474-8710

Aichi Children's Health and Medical Center(NW), Ōbu

330-8777

Saitama Children's Medical Center(NW), Saitama

330-8503

Jichi Children's Medical Center Tochigi, Saitama-shi

565-0871

Osaka University Hospital, Suita

Osaka University Hospital, Yamadaoka

162-8666

Tokyo Women's Medical University Hospital, Tokyo

187-0031

National Center Hospital, NCNP, Tokyo

683-8504

Tottori University Hospital, Tottori

232-0066

Kanagawa Children's Medical Center(NW), Yokohama

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Takeda Development Center Americas, Inc.

INDUSTRY

lead

Shire

INDUSTRY