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

Sponsors

Lead Sponsor: Acacia Pharma Ltd

Collaborator: Paion UK Ltd.

Source Acacia Pharma Ltd
Brief 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]).

Overall Status Not yet recruiting
Start Date 2021-05-01
Completion Date 2022-12-01
Primary Completion Date 2022-12-01
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Success of the procedure 2 hours
Secondary Outcome
Measure Time Frame
Target depth of sedation achieved 2 hours
Target range of sedation achieved during 80% of procedure duration 2 hours
Percentage of time within target range of sedation 2 hours
Adequacy of sedation 2 hours
Time to start of procedure 2 hours
Time to fully alert 2 hours
Time to ready for discharge 2 hours
Signs of re-sedation 2 hours
Procedure success excluding cases where the procedure could not be completed for non sedative reasons 2 hours
Safety: AEs 4 days
Safety: emergence of delirium 2 hours
Safety: need for ventilation 2 hours
Safety: need for reversal 2 hours
PK: assessment of plasma concentration-time relationship 3.5 hours
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Remimazolam

Description: Remimazolam for intravenous sedation

Arm Group Label: All Patients

Eligibility

Criteria:

Inclusion Criteria: - Signed informed consent form and/or assent and willingness of patient and parent(s) to participate in the trial. - In US sites: Paediatric male or female patients, aged ≥3 and <18 years scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial. - In European sites: Paediatric male or female patients, aged full term birth to <18 years scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial. - Maximum planned duration of procedure: 2 hours - ASA Physical Status I-III - Planned spontaneous breathing during sedation - A female who is of child bearing potential (i.e. after menarche) and sexually active must use a highly effective method of birth control during the trial period (from the time of consent until all specified observations are completed) - Negative pregnancy test at screening and on treatment day - Exclusion Criteria: - Emergency procedures - Condition/procedure that requires planned airway control via endotracheal tube or LMA/IGEL insertion - Cranio-facial malformation, which would severely limit the possibilities for emergency airway rescue - Other abnormalities relating to the airway (including large tonsils and anatomical abnormalities of upper airway or lower airway) which may compromise emergency airway rescue - Known hypersensitivity to benzodiazepines, flumazenil, dextran or any of the ingredients of the drug product - Known paradoxical reactions to benzodiazepines - History of sleep apnoea - Active respiratory failure - Active neuromuscular disease - Active cardiac failure - Active hepatic failure - Breast feeding females - Prohibited medication - Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the trial for any other reason

Gender:

All

Minimum Age:

N/A

Maximum Age:

17 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Gabriel Fox

Phone: +44-(0)1223-919764

Email: [email protected]

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: All Patients

Type: Experimental

Description: All paediatric patients undergoing diagnostic and/or therapeutic procedures

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: A Phase 2/3 prospective, open-label trial

Primary Purpose: Supportive Care

Masking: None (Open Label)

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