At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 25 enrolled
Drug / intervention
SHP615drug
Likely dose
SHP615 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Open-label Study to Determine the Efficacy, Safety, and Pharmacokinetics of Buccally Administered MHOS/SHP615 in Pediatric Patients With Status Epilepticus (Convulsive) in the Hospital or Emergency Room
In Brief
A Phase 3 clinical trial evaluating SHP615 for Nervous System Diseases. Completed, enrolled 25 participants across 23 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNervous System Diseases
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartOct 2017
First PostedNov 2017
Primary CompletionAug 2019
TodayJul 2026
First PostedNov 8, 2017
Enrollment StartOct 23, 2017
Primary CompletionAug 19, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.7 years ago
Interventions
SHP615drug
SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg).