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

NCT06554288 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-18

No results posted yet for this 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.

Conditions

  • Pediatric Disorder
  • Genetic Predisposition
  • Dystonia, Secondary
  • Dystonia
  • Cerebral Palsy, Dystonic-Rigid
  • Cerebral Palsy, Dyskinetic
  • Trihexyphenidyl Adverse Reaction
  • Pharmacogenomic Drug Interaction

Interventions

DRUG

Trihexyphenidyl

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

Sponsors & Collaborators

  • University of Kansas Medical Center

    collaborator OTHER

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Rose Gelineau-Morel, MD · Children's Mercy Kansas City

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2029-11-30
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06554288 on ClinicalTrials.gov