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NCT06554288PHASE1Recruiting

Pharmacogenomic Contributions to Trihexyphenidyl Biotransformation and Response in Children With Dystonic Cerebral Palsy

Children's Mercy Hospital Kansas City

Start Date

10/15/2024

Completion Date

12/31/2029

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 person's 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.

Eligibility Criteria

Age Range: 5 years to 17 years

Inclusion Criteria: * 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 Criteria: * 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

Interventions

DRUG

Trihexyphenidyl

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Conditions

Pediatric DisorderGenetic PredispositionDystonia, SecondaryDystoniaCerebral Palsy, Dystonic-RigidCerebral Palsy, DyskineticTrihexyphenidyl Adverse ReactionPharmacogenomic Drug Interaction

Locations

Children's Mercy Hospital Kansas City

Kansas City, Missouri 64108

United States