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Benzodiazepine

Remimazolam for Sedation in Children's Medical Procedures

Phase 2 & 3
Waitlist Available
Research Sponsored by Acacia Pharma Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 hours
Awards & highlights

Study Summary

This trial will test how well remimazolam works in children undergoing medical procedures.

Who is the study for?
This trial is for children with acute lymphoblastic leukemia needing sedation for medical procedures. In the US, it's for those aged 3-17; in Europe, from birth to <18 years. Participants must be able to breathe on their own during sedation and girls of childbearing age must use effective birth control. It excludes emergencies, known drug allergies, active organ failures, airway abnormalities that complicate emergency procedures, neuromuscular diseases, sleep apnoea or cardiac issues.Check my eligibility
What is being tested?
The trial tests intravenous remimazolam's ability to safely induce and maintain sedation in pediatric patients undergoing various medical procedures. The goal is to find out if this medication can keep children comfortably asleep without affecting their breathing during short-term treatments lasting up to two hours.See study design
What are the potential side effects?
Possible side effects of remimazolam may include reactions similar to other benzodiazepines such as drowsiness after the procedure, headaches, nausea or vomiting. There might also be a risk of slowed breathing or paradoxical reactions like restlessness and increased anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I, and if applicable, my parent(s), agree to participate in the trial.
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I am a child aged 3 to 17, scheduled for a medical procedure not related to this trial.
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I am under 18, in Europe, and scheduled for a medically necessary procedure unrelated to the trial.
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I am using effective birth control as a sexually active woman who can have children.
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My procedure is planned to last no more than 2 hours.
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My overall health is good to moderately impaired.
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I will breathe on my own during sedation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Success of the procedure
Secondary outcome measures
Adequacy of sedation
PK: assessment of plasma concentration-time relationship
Percentage of time within target range of sedation
+11 more

Side effects data

From 2016 Phase 3 trial • 461 Patients • NCT02290873
39%
Hypotension
20%
Hypertension
11%
Bradycardia
10%
Diastolic Hypertension
8%
Tachycardia
8%
Diastolic Hypotension
5%
Systolic hypertension
2%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Remimazolam
Placebo
Midazolam

Trial Design

1Treatment groups
Experimental Treatment
Group I: All PatientsExperimental Treatment1 Intervention
All paediatric patients undergoing diagnostic and/or therapeutic procedures
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remimazolam
2022
Completed Phase 4
~2850

Find a Location

Who is running the clinical trial?

Paion UK Ltd.Industry Sponsor
15 Previous Clinical Trials
2,537 Total Patients Enrolled
Acacia Pharma LtdLead Sponsor
17 Previous Clinical Trials
4,560 Total Patients Enrolled

Media Library

Remimazolam (Benzodiazepine) Clinical Trial Eligibility Overview. Trial Name: NCT04851717 — Phase 2 & 3
Acute Lymphoblastic Leukemia Research Study Groups: All Patients
Acute Lymphoblastic Leukemia Clinical Trial 2023: Remimazolam Highlights & Side Effects. Trial Name: NCT04851717 — Phase 2 & 3
Remimazolam (Benzodiazepine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04851717 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I enroll in the clinical research?

"This study needs 100 young participants, 17 years old or younger, who currently have all pediatric. Furthermore, it is essential that potential participants also meet the following requirements: For US patients: Male or female patients, aged 3 to <18 years, who are scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial. For European patients: Male or female patients, aged full term birth to <18 years, who are scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial. A female who is of child bearing potential (i.e. after menarche) and"

Answered by AI

Does the age limit for this trial include people over 75 years old?

"This particular clinical trial is testing the experimental medication on patients that are below the age of 18."

Answered by AI

In how many different geographical areas is this medical study being run today?

"Right now, this trial has 6 sites where patients can enroll. The sites are in Pittsburgh, Palo Alto, Sacramento, and 6 other locations. If you want to participate in the study, try to choose the location that is closest to you so that you won't have to travel too much."

Answered by AI

What other research studies have included Remimazolam as a variable?

"Remimazolam was first studied in 2020 at Tianjin NanKai hospital. As of now, there have been a total of 37 completed studies. Currently, there are 14 live clinical trials, with a large portion of these taking place in Pittsburgh, Pennsylvania."

Answered by AI
~22 spots leftby Dec 2024