Trihexyphenidyl for Cerebral Palsy
(TRIKE2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
Is trihexyphenidyl safe for use in children with cerebral palsy?
Trihexyphenidyl has been studied in children with cerebral palsy and is generally considered safe, though some children experienced nonserious side effects like chorea (involuntary movements), drug rash, and hyperactivity. Most side effects were temporary, but there is a potential for dependence, so it should be used with caution.12345
How does the drug trihexyphenidyl differ from other treatments for cerebral palsy?
Trihexyphenidyl is unique because it is an anticholinergic drug that helps improve motor function in children with dystonic cerebral palsy, particularly in those without spasticity and with higher cognitive abilities. It works by inhibiting muscarinic cholinergic receptors in the brain, which can enhance dopamine activity, and is often used when oral medications are the first line of treatment for dystonia.12367
What evidence supports the effectiveness of the drug trihexyphenidyl for treating cerebral palsy?
Research shows that trihexyphenidyl can improve arm and hand function, as well as expressive language, in children with cerebral palsy, especially those without spasticity and with higher cognitive abilities. Younger children tend to respond better, and while some side effects may occur, they are generally not serious.12346
Who Is on the Research Team?
Rose Gelineau-Morel, MD
Principal Investigator
Children's Mercy Kansas City
Are You a Good Fit for This Trial?
This trial is for children aged 5-17 with dystonic cerebral palsy, where the condition interferes with their daily life. A parent or legal guardian must give informed permission for the child to participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive trihexyphenidyl following a dose escalation schedule to evaluate pharmacokinetics and genotype variations
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Trihexyphenidyl
Trihexyphenidyl is already approved in United States, European Union for the following indications:
- Parkinson's disease
- Drug-induced extrapyramidal symptoms
- Dystonic cerebral palsy
- Parkinson's disease
- Drug-induced extrapyramidal symptoms
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Mercy Hospital Kansas City
Lead Sponsor
University of Kansas Medical Center
Collaborator