Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pediatric ALL
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: A Phase 2/3 prospective, open-label trialMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Younger than 17 years
- Gender
- Both males and females
Description
This trial is part of the European Paediatric Investigational Plan and the US Pediatric Study Plan and has been developed in line with guidance from the EMA Paediatric Committee and the US FDA. The trial will commence with cohort 1 (aged ?6 and <18 years) and proceed to lower age groups: cohort 2 (?...
This trial is part of the European Paediatric Investigational Plan and the US Pediatric Study Plan and has been developed in line with guidance from the EMA Paediatric Committee and the US FDA. The trial will commence with cohort 1 (aged ?6 and <18 years) and proceed to lower age groups: cohort 2 (?3 and <6 years); and, in European sites only, cohort 3 (full-term birth to <3 years). The Data Monitoring committee (DMC) may convene any time after at least half of the subjects in cohort 1 or 2 have completed the study, to review PK,safety and efficacy data. If there are no concerns, the DMC may recommend to initiate concurrent dosing in the next younger cohort (cohort 2 or 3) in parallel to dosing the remaining subjects in cohort 1 or 2 Dosing for cohort 3 will be predicted based on PK modelling as well as efficacy and safety outcomes of the older age groups. Enrolment of patients aged <2 years will not be permitted until supported by adequate juvenile toxicity data. The trial will consist of three visits: Screening (Day -21 to day 1),Treatment (Day 1), and Follow-up (Day 4 [+3/-1 days]).
Tracking Information
- NCT #
- NCT04851717
- Collaborators
- Paion UK Ltd.
- Investigators
- Not Provided