Pharmacogenomic Contribution to the Biotransformation of Trihexyphenidyl and Development of a Precision Dosing Model for Children With Dystonia and Cerebral Palsy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:
• 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
Locations
United States
Missouri
Children's Mercy Hospital Kansas City
RECRUITING
Kansas City
Contact Information
Primary
Rose Gelineau-Morel, MD
rngelineaumorel@cmh.edu
816-302-3331
Backup
Rachel Nass
rnass@cmh.edu
8166011354
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Trihexyphenidyl
Participants receive trihexyphenidyl following the dose escalation schedule below:~Week 1: 0.05 mg/kg BID Week 2: 0.05 mg/kg TID Week 3: 0.1 mg/kg TID Week 4: 0.15 mg/kg TID Week 5: 0.20 mg/kg TID Week 6-15: 0.25 mg/kg TID
Related Therapeutic Areas
Sponsors
Collaborators: University of Kansas Medical Center
Leads: Children's Mercy Hospital Kansas City