RecruitingPhase 1

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

United States40 participantsStarted 2024-10-15

Plain-language 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.

Who can participate

Age range5 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Difference in Cmax between CYP2D6 and CYP2C19 phenotype groups

Timeframe: Baseline

Difference in AUC0-n between CYP2D6 and CYP2C19 phenotype groups

Timeframe: Baseline

Difference in AUC0-∞ between CYP2D6 and CYP2C19 phenotype groups

Timeframe: Baseline

Recruitment percentage

Timeframe: Through study completion, an average of 2 years

Retention percentage

Timeframe: Through study completion, an average of 2 years

Dystonia Efficacy Measures Outcome Completion

Timeframe: Through study completion, an average of 2 years

Trial details

NCT IDNCT06554288

SponsorChildren's Mercy Hospital Kansas City

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-11-30

Contact for this trial

Rose Gelineau-Morel, MD

816-302-3331 rngelineaumorel@cmh.edu

View on ClinicalTrials.gov More Pediatric Disorder trials

Plain-language summary

Who can participate

Age range5 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Difference in Cmax between CYP2D6 and CYP2C19 phenotype groups

Timeframe: Baseline

Difference in AUC0-n between CYP2D6 and CYP2C19 phenotype groups

Timeframe: Baseline

Difference in AUC0-∞ between CYP2D6 and CYP2C19 phenotype groups

Timeframe: Baseline

Recruitment percentage

Timeframe: Through study completion, an average of 2 years

Retention percentage

Timeframe: Through study completion, an average of 2 years

Dystonia Efficacy Measures Outcome Completion

Timeframe: Through study completion, an average of 2 years