Status:
RECRUITING
Pharmacogenomic Contributions to Trihexyphenidyl Biotransformation and Response in Children With Dystonic Cerebral Palsy
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
University of Kansas Medical Center
Conditions:
Pediatric Disorder
Genetic Predisposition
Eligibility:
All Genders
5-17 years
Phase:
PHASE1
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 pediat...
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...
Eligibility Criteria
Inclusion
- Ages 5-17 years of age
- Diagnosis of cerebral palsy and dystonia causing interference
- Parent/legal guardian of a child with a diagnosis of cerebral palsy and dystonia
- Parent/legal guardian is willing and able to provide informed permission/assent for the study
Exclusion
- Previously or currently taking trihexyphenidyl
- Patients turning 18 years of age within the study period (16 weeks from Study Day 1)
- A language barrier for the patient that precludes communication and/or the ability to complete study-related requirements
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06554288
Start Date
October 15 2024
End Date
December 31 2029
Last Update
July 18 2025
Active Locations (1)
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1
Children's Mercy Hospital Kansas City
Kansas City, Missouri, United States, 64108