What this study is
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.
What's being tested
- Trihexyphenidyl
Intervention · DRUG
6-week dose escalation up to 0.25mg/kg TID, followed by a 9-week maintenance period at this dose
Study details
- Official title
- Pharmacogenomic Contribution to the Biotransformation of Trihexyphenidyl and Development of a Precision Dosing Model for Children With Dystonia and Cerebral Palsy
- Sponsor
- Children's Mercy Hospital Kansas City
- Conditions
- Pediatric Disorder · Genetic Predisposition · Dystonia, Secondary · Dystonia · Cerebral Palsy, Dystonic-Rigid · Cerebral Palsy, Dyskinetic · Trihexyphenidyl Adverse Reaction · Pharmacogenomic Drug Interaction
- Enrolling
- 40 people
- Starts
- 2024-10-15
- Est. completion
- 2029-12-31
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 5 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChildren's Mercy Hospital Kansas City
Kansas City, Missouri, United States
- Rachel Nass · Contact816-601-1354rnass@cmh.edu
- Rose Gelineau-Morel, MD · Principal investigator
Recruiting
Study team
Sponsor
Children's Mercy Hospital Kansas City
Study ID STUDY00003228
Principal investigator
Rose Gelineau-Morel, MD
Children's Mercy Kansas City
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.