Study Summary
This trial tests how a drug affects the body in babies up to 23 months old, given intravenously before a MRI.
- Pediatric Disorders
- Body Dysmorphia
- Central Nervous System Disorders
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
7 Primary · 0 Secondary · Reporting Duration: A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
3 Treatment Groups
Age Group 1: patients aged 3 to 23 months
1 of 3
Age Group 3: patients aged from birth to 27 days (term newborns)
1 of 3
Age Group 2: patients aged 28 days to less than 3 months
1 of 3
Experimental Treatment
50 Total Participants · 3 Treatment Groups
Primary Treatment: Age Group 1: patients aged 3 to 23 months · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age < 18 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Are there still vacancies to participate in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this experiment has been recruiting since September 21st 2022 and is still ongoing with the last update taking place on October 21st 2022. The research team are currently seeking 50 participants from two separate sites for their study." - Anonymous Online Contributor
What is the scale of participation in this trial?
"Affirmative, clinicaltrials.gov's information indicates that this experiment is still recruiting individuals. This initiative began on September 21st 2022 and was recently edited on October 21st 2022. For the study to be successful, 50 people must enroll from two different sites." - Anonymous Online Contributor
What risks do people in Age Group 1: patients aged 3 to 23 months face?
"Given the Phase 2 trial status of this medication, with some safety data but none regarding efficacy, our team at Power rated its safety for Age Group 1 (3 to 23 months) a score of two." - Anonymous Online Contributor