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

NCT03336450 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-09-14

Study results available
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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.

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

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda Development Center Americas

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
216 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2020-10-13
Completion
2020-10-13

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336450 on ClinicalTrials.gov