CompletedPhase 3

Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan

Japan25 participantsStarted 2017-10-23

Plain-language summary

The purpose of this study is to assess the efficacy, safety and pharmacokinetics of MHOS/SHP615 administered buccally in children with status epilepticus (convulsive) in a healthcare setting.

Who can participate

Age range3 Months – 216 Months

SexALL

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Inclusion criteria

✓. 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) lasting \>=5 mins

What they're measuring

Percentage of Participants With Response Rate

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

Trial details

NCT IDNCT03336645

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-19

Results submitted2020-07-06

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