Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554288
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Pharmacogenomic Contributions to Trihexyphenidyl Biotransformation and Response in Children With Dystonic Cerebral Palsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pharmacogenomic Contribution to the Biotransformation of Trihexyphenidyl and Development of a Precision Dosing Model for Children With Dystonia and Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIKE2
Brief Summary:
This study looks at how a medicine called trihexyphenidyl works in children with dystonic cerebral palsy The study aims to understand how trihexyphenidyl is broken down and used in the body of pediatric patients and whether this is impacted by a persons genetics Information from this study will also be used to design future clinical trials
Detailed Description:
This is a 16-week single-arm nonrandomized pilot study of trihexyphenidyl in children with dystonic cerebral palsy DCP to 1 evaluate the pharmacokinetics PK of trihexyphenidyl THP and variation in PK parameters between CYP2D6 and CYP2C19 genotypes and 2 evaluate the feasibility of a future exposure-controlled clinical trial of THP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None