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

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Children's Mercy Hospital Kansas City
Study ID
NCT06554288
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Trihexyphenidyl — DRUG
    6-week dose escalation up to 0.25mg/kg TID, followed by a 9-week maintenance period at this dose

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Jul 2025
Primary completion
Nov 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Difference in Cmax between CYP2D6 and CYP2C19 phenotype groups [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Mercy Hospital Kansas CityKansas CityMissouri64108
Rachel Nass
[email protected]
8166011354
Rose Gelineau-Morel, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Children's Mercy Hospital Kansas City· Kansas City, MO

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