Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures

NCT04851717 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: DA10030CNS7056-026
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 8

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

Conditions

Pediatric ALL

Outcome Measures

Primary Outcomes (1)

• Success of the procedure

  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

  2 hours

Secondary Outcomes (14)

• 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

Study Arms (1)

All Patients

EXPERIMENTAL

All paediatric patients undergoing diagnostic and/or therapeutic procedures

Drug: Remimazolam

Interventions

Remimazolam DRUG

Remimazolam for intravenous sedation

All Patients

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Acacia Pharma Ltd: lead
• Paion UK Ltd.: collaborator

Study Sites (8)

Stanford University

Palo Alto, California, 94306, United States

Location

University of California Davis Children's Hospital

Sacramento, California, 95817, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55455, United States

Location

University of Pittsburgh Medical Center - Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Rigshospitalet

Copenhagen, Denmark

Location

Odense Universitetshospital

Odense, Denmark

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

remimazolam

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: November 15, 2021
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); DK (2)