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:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shire
Collaborator:
Takeda Development Center Americas, Inc.
Treatments:
Midazolam
Pharmaceutical Solutions
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.