Status:
ACTIVE_NOT_RECRUITING
Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
Lead Sponsor:
Acacia Pharma Ltd
Collaborating Sponsors:
Paion UK Ltd.
Conditions:
Pediatric ALL
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE2
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04851717
Start Date
November 15 2021
End Date
October 1 2027
Last Update
July 1 2025
Active Locations (8)
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1
Stanford University
Palo Alto, California, United States, 94306
2
University of California Davis Children's Hospital
Sacramento, California, United States, 95817
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
4
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States, 55455