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Anticholinergic

Trihexyphenidyl for Cerebral Palsy (TRIKE2 Trial)

Phase 1

Recruiting

Led By Rose Gelineau-Morel, MD

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Ages 5-17 years of age

* Diagnosis of cerebral palsy and dystonia causing interference

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating how a medication called trihexyphenidyl affects children with dystonic cerebral palsy. Researchers want to learn how the body processes this medication in pediatric patients and if genetics play

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, trihexyphenidyl can typically cause dry mouth, blurred vision, dizziness, nausea, and constipation among other anticholinergic effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 5 and 17 years old.

Select...

I have cerebral palsy and dystonia that affects my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in AUC0-n between CYP2D6 and CYP2C19 phenotype groups

Difference in AUC0-∞ between CYP2D6 and CYP2C19 phenotype groups

Difference in Cmax between CYP2D6 and CYP2C19 phenotype groups

+3 more

Secondary study objectives

Change from baseline in dystonia amplitude as measured by the Dyskinesia Impairment Scale (exploratory)

Change from baseline in dystonia as measured by the Quality of Upper Extremity Skills Test (QUEST) (exploratory)

Change from baseline in dystonia duration as measured by the Dyskinesia Impairment Scale (exploratory)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 2Eligibility criteria met