Understanding how trihexyphenidyl works in children with dystonic cerebral palsy
Official title: Pharmacogenomic Contribution to the Biotransformation of Trihexyphenidyl and Development of a Precision Dosing Model for Children With Dystonia and Cerebral Palsy
Run by Children's Mercy Hospital Kansas City · NCT06554288 · Data updated 2026-11-12
This study is testing how well the medication trihexyphenidyl works for children with dystonic cerebral palsy and if their genes affect how the drug works.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Status | Recruiting |
| Started | October 15, 2024 |
| Main results expected | November 30, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT06554288 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 5-17 diagnosed with cerebral palsy and dystonia that interferes with their daily activities.
✕Probably not a fit
Patients who are currently taking trihexyphenidyl or will turn 18 during the study period may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of trihexyphenidyl in children aged 5-17 with dystonic cerebral palsy. It aims to evaluate how the medication is metabolized in the body and whether genetic factors influence its effectiveness. The study will last for 16 weeks and will help inform the design of future clinical trials based on the findings regarding pharmacokinetics and genetic variations. It is a single-arm, nonrandomized pilot study focused on understanding the drug's biotransformation and response in pediatric patients.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for children with dystonic cerebral palsy.
How similar studies have gone: While pharmacogenomic approaches in pediatric populations are being explored, this specific study's focus on trihexyphenidyl and its genetic interactions is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Children's Mercy Hospital Kansas City
Kansas City, Missouri, United States Recruiting
Study contacts
- Principal investigator: Rose Gelineau-Morel, MD — Children's Mercy Kansas City
- Study coordinator: Rose Gelineau-Morel, MD
- Email: rngelineaumorel@cmh.edu
- Phone: 816-302-3331
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.