CompletedPhase 3

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

Japan3 participantsStarted 2018-04-23

Plain-language 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.

Who can participate

Age range6 Months – 216 Months

SexALL

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Inclusion criteria

✓. Properly administer MHOS/SHP615.
✓. 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.)
✓. Follow the necessary instructions to secure the safety of the subject.
✓. Currently presenting with seizure (convulsive) activity and 3 or more convulsions within the preceding hour
✓. Currently presenting with seizure (convulsive) and 2 or more convulsions in succession without recovery of consciousness.
✓. Currently presenting with a single seizure (convulsive) persisting greater than or equal to (\>=) 5 minutes.

What they're measuring

Efficacy: Number of Participants With Therapeutic Success

Timeframe: From start of study drug administration up to 30 minutes post-dose

Safety: Number of Participants With Respiratory Depression

Timeframe: Up to 24 hours post-dose

Trial details

NCT IDNCT03336450

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-13

Results submitted2021-06-30

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