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

NCT ID: NCT03336450

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-23
• Study Completion Date: 2020-10-13

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHP615

Participants will receive a single age-specific dose (approximately 0.25 to 0.5 milligram per kilogram \[mg/kg\] as midazolam) of SHP615 oromucosal solution through buccal route upon onset of seizures.

Group Type: EXPERIMENTAL

SHP615

Intervention Type: DRUG

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

MHOS/SHP615

Intervention Type: DRUG

MHOS/SHP615

Interventions

SHP615

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

Intervention Type: DRUG

MHOS/SHP615

MHOS/SHP615

Intervention Type: DRUG

Other Intervention Names

MHOS; Midazolam hydrochloride oromucosal solution

Eligibility Criteria

Inclusion Criteria

• Subjects who completed the SHP615-301 study and who tolerated and responded to treatment with MHOS/SHP615 in the hospital and/or emergency room, and are considered stable for discharge from the hospital.
• Subjects who are greater than (>) 6 months and less than (<) 18 years of age at the time of investigational product administration. If the subject's exact age is not known, the subject should be excluded.
• Parent, guardian, or legally authorized representative of the child who provides informed consent and assent (when applicable) to participate in the study after initial stabilization of the subject with SE in hospital or emergency room during the SHP615-301 study. The subject also provides informed consent prior to participation, where applicable.
• Parent, guardian, or legally authorized representative who have received appropriate training/education and are deemed qualified by the investigator and are willing to:

1. Properly administer MHOS/SHP615.

2. Record seizure information and dosing of MHOS/SHP615 in a subject diary (including time of seizure onset, type of seizure, time necessary to administer MHOS/SHP615, time between MHOS/SHP615 administration to seizure cessation, etc.)

3. Follow the necessary instructions to secure the safety of the subject.

• Subjects who experience generalized tonic-clonic SE with seizures accompanied by loss of consciousness with any of the following characteristics persistent at the time of study drug administration:

1. Currently presenting with seizure (convulsive) activity and 3 or more convulsions within the preceding hour

2. Currently presenting with seizure (convulsive) and 2 or more convulsions in succession without recovery of consciousness.

3. Currently presenting with a single seizure (convulsive) persisting greater than or equal to (>=) 5 minutes.

Exclusion Criteria

• Female subjects who are pregnant, suspected to be pregnant, or nursing.
• Subjects with major trauma, not necessarily restricted to the head, as the cause of the seizure.
• Subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal.
• Subjects with seizures due to illegal drug or acute alcoholic intoxication.
• Subjects with seizures of psychogenic origin.
• Subjects with seizures due to severe encephalitis or meningitis, as determined by the PI
• Subjects with known history of hypersensitivities, nonresponsiveness or contraindications to benzodiazepines (that is (ie), clinically significant respiratory depression, severe acute hepatic failure, myasthenia gravis, syndrome of sleep apnea, glaucoma with closed angle, or use of concomitant drugs determined by the investigator to have a contraindication to the use of benzodiazepines.)
• Subjects with a known history of benzodiazepine abuse.
• Subjects who have not responded to previous administrations of midazolam systemic therapies, including MIDAFRESA and/or DORMICUM.
• Subjects who need emergent surgical intervention and general anesthesia/intubation.
• Subjects who have been receiving human immunodeficiency virus (HIV) protease inhibitors or HIV reverse transcriptase inhibitors.
• Subjects with severe cerebral anoxia (except cerebral palsy), in the judgment of the healthcare provider.
• Have used an investigational product or been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
• Subject has prior placement of a vagus nerve stimulator.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 216 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Development Center Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda Development Center Americas

Locations

Yamanashi Prefectural Central Hospital

Kofu, Fujimi, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

NHO Minami-Okayama Medical Center

Okayama, Okayama-ken, Japan

Tokyo Women's Medical University Yachiyo Medical Center

Yachiyo, Owada Shinden, Japan

Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Shizuoka, Japan

Fukuoka Children's Hospital(NW)

Fukuoka, , Japan

Gifu Prefectural General Medical Center

Gifu, , Japan

NHO Hokkaido Medical Center

Hokkaidō, , Japan

Kumamoto Saishunso National Hospital

Kumamoto, , Japan

NHO Nagasaki Medical Center

Nagasaki, , Japan

NHO Nishi Niigata Chuo National Hospital

Niigata, , Japan

Okayama University Hospital

Okayama, , Japan

Nakano Children's Hospital

Osaka, , Japan

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

Osaka, , Japan

Aichi Children's Health and Medical Center(NW)

Ōbu, , Japan

Saitama Children's Medical Center(NW)

Saitama, , Japan

Jichi Children's Medical Center Tochigi

Saitama-shi, , Japan

Osaka University Hospital

Suita, , Japan

Tokyo Women's Medical University Hospital

Tokyo, , Japan

National Center Hospital, NCNP

Tokyo, , Japan

Tottori University Hospital

Tottori, , Japan

Osaka University Hospital

Yamadaoka, , Japan

Kanagawa Children's Medical Center(NW)

Yokohama, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SHP615-302

Identifier Type: -

Identifier Source: org_study_id