Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting
Condition: Nervous System Diseases
MeSH terms: Nervous System Diseases; Status Epilepticus
Intervention: SHP615; MHOS/SHP615
Intervention description: SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg).; MHOS/SHP615
Intervention MeSH terms: Midazolam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 6 Months
Maximum age: 216 Months
Healthy volunteers: No

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.
    

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.