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Trihexyphenidyl for Dystonic Cerebral Palsy Study

This study is looking at how the medicine trihexyphenidyl works in children with dystonic cerebral palsy. Researchers want to understand how the body processes trihexyphenidyl and if a child's genes (genetics) play a role. The study will also help plan future research. You may be able to join if you are a child between 5 and 17 years old with cerebral palsy and dystonia that causes problems, and you have not taken trihexyphenidyl before. The study aims to measure how much of the drug is in the body at different times. The current status of the study is unclear, and it plans to enroll 40 participants.

Study design
This is a single-arm study, meaning all participants receive the same treatment, and it plans to enroll 40 children. It is a pilot study, which helps test the approach for future, larger studies.
What's involved
Participants will take trihexyphenidyl, starting with a 6-week period where the dose gradually increases, followed by a 9-week period at a stable dose.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for the study are taken at Baseline, but the study intervention lasts for 16 weeks.

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NCT06554288

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

Recruiting
PHASE1Ages 5–17InterventionalTreatment
Children's Mercy Hospital Kansas City
~40 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Trihexyphenidyl

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in Cmax between CYP2D6 and CYP2C19 phenotype groups
Measured over Baseline
+5 more outcomes measured

Conditions

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

Explore related trials

Cerebral PalsyDystonia

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

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

Who to contact

Rose Gelineau-Morel, MD
[email protected]
816-302-3331
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Difference in Cmax between CYP2D6 and CYP2C19 phenotype groupsBaseline

    Cmax will be measured in first-dose pharmacokinetic study on study day 1

  • Difference in AUC0-n between CYP2D6 and CYP2C19 phenotype groupsBaseline

    AUC0-n will be measured in first-dose pharmacokinetic study on study day 1

  • Difference in AUC0-∞ between CYP2D6 and CYP2C19 phenotype groupsBaseline

    AUC0-∞ will be measured in first-dose pharmacokinetic study on study day 1

  • Recruitment percentageThrough study completion, an average of 2 years

    Measure percent of participants who were approached for the study that enrolled in the study

  • Retention percentageThrough study completion, an average of 2 years

    Measure percent of participants enrolled who completed the study

  • Dystonia Efficacy Measures Outcome CompletionThrough study completion, an average of 2 years

    Measure percent of participants enrolled who were able to complete each dystonia efficacy measure (see secondary outcome measures)