RecruitingPhase 1NCT06554288

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

Pharmacogenomic Contribution to the Biotransformation of Trihexyphenidyl and Development of a Precision Dosing Model for Children With Dystonia and Cerebral Palsy


Sponsor

Children's Mercy Hospital Kansas City

Enrollment

40 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 5 YearsMax Age: 17 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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

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Interventions

DRUGTrihexyphenidyl

6-week dose escalation up to 0.25mg/kg TID, followed by a 9-week maintenance period at this dose


Locations(1)

Children's Mercy Hospital Kansas City

Kansas City, Missouri, United States

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NCT06554288


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