40 Participants Needed

Trihexyphenidyl for Cerebral Palsy

(TRIKE2 Trial)

RG
RN
Overseen ByRachel Nass
Age: < 18
Sex: Any
Trial Phase: Phase 1
Sponsor: Children's Mercy Hospital Kansas City
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

RG

Rose Gelineau-Morel, MD

Principal Investigator

Children&#39;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

I have cerebral palsy and dystonia that affects my daily activities.
I am between 5 and 17 years old.
My parent or guardian agrees to let me join the study.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trihexyphenidyl following a dose escalation schedule to evaluate pharmacokinetics and genotype variations

16 weeks
Weekly visits for dose adjustments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Trihexyphenidyl
Trial Overview The study investigates how trihexyphenidyl, a medication used to treat dystonia in cerebral palsy patients, is processed by the body and if genetics affect this process. It will help design future trials.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: TrihexyphenidylExperimental Treatment1 Intervention
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

Trihexyphenidyl is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Artane for:
  • Parkinson's disease
  • Drug-induced extrapyramidal symptoms
  • Dystonic cerebral palsy
🇪🇺
Approved in European Union as Trihexyphenidyl for:
  • 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

Trials
261
Recruited
941,000+

University of Kansas Medical Center

Collaborator

Trials
527
Recruited
181,000+

Published Research Related to This Trial

In a study of 22 children with extrapyramidal cerebral palsy, trihexyphenidyl showed significant improvements in upper extremity function and expressive language, with many parents reporting high levels of positive change.
Younger children tended to respond better to trihexyphenidyl, indicating that age at treatment initiation may influence the effectiveness of the medication, particularly for fine motor skills and communication.
Age-dependent effects of trihexyphenidyl in extrapyramidal cerebral palsy.Hoon, AH., Freese, PO., Reinhardt, EM., et al.[2022]
A retrospective analysis of 31 children with dystonia showed that high-dose trihexyphenidyl (>0.5 mg/kg/day) led to reported improvements in motor function, especially in those without spasticity and with higher cognitive abilities.
Most caregivers noted improvements in areas like arm and hand function, with side effects being mostly transient, indicating that trihexyphenidyl can be a safe and effective treatment option for specific subgroups of children with dystonia.
Trihexyphenidyl improves motor function in children with dystonic cerebral palsy: a retrospective analysis.Ben-Pazi, H.[2013]
In a pilot trial involving 23 children with cerebral palsy and secondary dystonia, high-dose trihexyphenidyl showed significant improvement in arm function after 15 weeks, indicating potential efficacy for this treatment.
However, some children with hyperkinetic dystonia experienced worsening symptoms at 9 weeks, suggesting that trihexyphenidyl may not be suitable for all types of dystonia, highlighting the need for further research to clarify its effectiveness and safety.
Prospective open-label clinical trial of trihexyphenidyl in children with secondary dystonia due to cerebral palsy.Sanger, TD., Bastian, A., Brunstrom, J., et al.[2022]

Citations

Age-dependent effects of trihexyphenidyl in extrapyramidal cerebral palsy. [2022]
Trihexyphenidyl improves motor function in children with dystonic cerebral palsy: a retrospective analysis. [2013]
Prospective open-label clinical trial of trihexyphenidyl in children with secondary dystonia due to cerebral palsy. [2022]
Gabapentin as Add-on Therapy to Trihexyphenidyl in Children with Dyskinetic Cerebral Palsy: A Randomized, Controlled Trial. [2023]
Trihexyphenidyl in posthemorrhagic dystonia: motor and language effects. [2019]
Trihexyphenidyl dependence. [2019]
Trihexyphenidyl for dystonia in cerebral palsy. [2022]
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