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Personalized dosing for kids with dystonia? new study investigates genetic factors

NCT ID NCT06554288

Knowledge-focused Sponsor: Children's Mercy Hospital Kansas City Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing how the drug trihexyphenidyl is processed in the bodies of 40 children aged 5-17 with dystonic cerebral palsy. Researchers want to see if a child's genetic makeup changes how the drug works, which could help create personalized dosing plans. Participants will take the drug for 15 weeks, and the study will measure drug levels, side effects, and how well dystonia symptoms are controlled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trihexyphenidyl
What this could lead to
If successful, this could lead to personalized dosing guidelines for trihexyphenidyl in children with dystonia, improving treatment effectiveness and safety.
What could go wrong
This is an early Phase 1 study with only 40 participants, so results may not apply to all children. The focus is on understanding drug metabolism, not on proving the drug works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Previously or currently taking trihexyphenidyl * Patients turning 18 years of age within the study period (16 weeks from Study Day 1) * A language barrier for the patient that precludes communication and/or the ability to complete study-related requirements

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Conditions

The condition(s) this trial relates to.

athetoid cerebral palsy cerebral palsy Dystonia dystonic disorder inherited disease susceptibility mixed cerebral palsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebral palsy, dyskinetic Cerebral palsy, dystonic-rigid Dystonia Dystonia, secondary Genetic predisposition Pediatric disorder Pharmacogenomic drug interaction Trihexyphenidyl adverse reaction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Mercy Hospital Kansas City

    RECRUITING

    Kansas City, Missouri, 64108, United States

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