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

Last updated: July 17, 2025
Sponsor: Children's Mercy Hospital Kansas City
Overall Status: Active - Recruiting

Phase

1

Condition

Cataplexy

Dyskinesias

Cerebral Palsy

Treatment

Trihexyphenidyl

Clinical Study ID

NCT06554288
STUDY00003228
  • Ages 5-17
  • All Genders

Study 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 Criteria

Inclusion

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 forthe study

Exclusion

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 abilityto complete study-related requirements

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Trihexyphenidyl
Phase: 1
Study Start date:
October 15, 2024
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • Children's Mercy Hospital Kansas City

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

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