At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3 enrolled
Drug / intervention
SHP615 +1 moredrug
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 Extension Study of Buccally Administered MHOS/SHP615 in Pediatric Patients With Status Epilepticus (Convulsive) in Community Settings
In Brief
A Phase 3 clinical trial evaluating SHP615 and MHOS/SHP615 for Nervous System Diseases. Completed, enrolled 3 participants across 23 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNervous System Diseases
CountriesJapan
CollaboratorsTakeda Development Center Americas, Inc.
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartApr 2018
Primary CompletionOct 2020
TodayJul 2026
First PostedNov 8, 2017
Enrollment StartApr 23, 2018
Primary CompletionOct 13, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 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).
MHOS/SHP615drug
MHOS/SHP615