NCT04851717

Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures

A Phase 2/3, Prospective, Open-label Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Remimazolam for Intravenous Sedation in Paediatric Patients Undergoing Diagnostic and/or Therapeutic Procedures

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Acacia Pharma Ltd · Industry
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures

Detailed 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 (≥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 \[+3/-1 days\]).

Conditions

• Pediatric ALL

Interventions

Type	Name	Description
DRUG	Remimazolam	Remimazolam for intravenous sedation

Timeline

• Start date: 2021-11-15
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2021-04-20
• Last updated: 2025-07-01

Locations

8 sites across 2 countries: United States, Denmark

Regulatory

• FDA-regulated drug study