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Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04851717
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : February 16, 2022
Sponsor:
Collaborator:
Paion UK Ltd.
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Pediatric ALL Drug: Remimazolam Phase 2 Phase 3

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]).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A Phase 2/3 prospective, open-label trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : November 15, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All Patients
All paediatric patients undergoing diagnostic and/or therapeutic procedures
Drug: Remimazolam
Remimazolam for intravenous sedation




Primary Outcome Measures :
  1. Success of the procedure [ Time Frame: 2 hours ]
    Success of the procedure defined as: Completion of the procedure AND no requirement for rescue sedative medication AND no requirement for more than the permitted bolus or infusion regimen


Secondary Outcome Measures :
  1. Target depth of sedation achieved [ Time Frame: 2 hours ]
    Proportion of patients achieving predefined target depth of sedation (assessed using University of Michigan Sedation Score [UMSS]) during procedure

  2. Target range of sedation achieved during 80% of procedure duration [ Time Frame: 2 hours ]
    Proportion of patients in whom predefined target range of sedation (assessed using University of Michigan Sedation Score [UMSS]) was achieved during at least 80% of procedure duration

  3. Percentage of time within target range of sedation [ Time Frame: 2 hours ]
    Percentage of time spent by patients within predefined target range of sedation (assessed using University of Michigan Sedation Score [UMSS]) during procedure

  4. Adequacy of sedation [ Time Frame: 2 hours ]
    Depth of sedation (assessed using Nurse Interpretation of Sedation Scale [NISS]) of patients over time

  5. Time to start of procedure [ Time Frame: 2 hours ]
    Time between initial administration of study drug and start of procedure

  6. Time to fully alert [ Time Frame: 2 hours ]
    Time between last dose of study drug, end of procedure and full alertness, defined as the first of three consecutive sedation scores showing no sedation

  7. Time to ready for discharge [ Time Frame: 2 hours ]
    Time between last dose of study drug, end of procedure and discharge readiness

  8. Signs of re-sedation [ Time Frame: 2 hours ]
    Occurrence, after reaching a University of Michigan Sedation Score (UMSS) of 0 after end of procedure, of a UMSS greater than zero

  9. Procedure success excluding cases where the procedure could not be completed for non sedative reasons [ Time Frame: 2 hours ]
    Success of the procedure defined as: Completion of the procedure AND no requirement for rescue sedative medication AND no requirement for more than the permitted bolus or infusion regimen; excluding any patients where procedure was not completed for reasons other than failure of sedation

  10. Safety: AEs [ Time Frame: 4 days ]
    Incidence of treatment-emergent adverse events

  11. Safety: emergence of delirium [ Time Frame: 2 hours ]
    Incidence of paediatric anaesthesia emergence delirium between end of procedure until fit for discharge

  12. Safety: need for ventilation [ Time Frame: 2 hours ]
    Incidence of use of any manual or mechanical ventilation

  13. Safety: need for reversal [ Time Frame: 2 hours ]
    Incidence of use of flumazenil for reversal of benzodiazepine effect

  14. PK: assessment of plasma concentration-time relationship [ Time Frame: 3.5 hours ]
    Graphical description of plasma concentration over time and comparison to predicted concentration-time relationship as calculated from existing pharmacokinetic/pharmacodynamic model



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851717


Contacts
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Contact: Gabriel Fox +44-(0)1223-919764 gabrielfox@acaciapharma.com
Contact: Joanna L Walker +44-(0)1223-919762 joannawalker@acaciapharma.com

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94306
Contact: Gregory Hammer, MD         
University of California Davis Children's Hospital Recruiting
Sacramento, California, United States, 95817
Contact: Rajvinder Dhamrait, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Keira Mason, MD         
United States, Minnesota
University of Minnesota Masonic Children's Hospital Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Kumar Belani, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center - Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Peter Davis, MD         
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Chyongjy Joyce Liu, DO         
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Volker Classen, MD         
Odense Universitetshospital Recruiting
Odense, Denmark
Contact: Tom Hansen, MD, PhD         
Sponsors and Collaborators
Acacia Pharma Ltd
Paion UK Ltd.
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Responsible Party: Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT04851717    
Other Study ID Numbers: DA10030
CNS7056-026 ( Other Identifier: PAION )
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No